Prurigo Nodularis, Pruritis
Conditions
Brief summary
Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).
Detailed description
This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus. Phase 2a portion: Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus are treated in the Phase 2a portion of the study. At Baseline, subjects are randomized 1:1 to receive double-blind (DBL) vixarelimab or placebo: vixarelimab 720 mg loading dose followed by 360 mg every week; placebo loading dose followed by placebo every week. The treatment period is 8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol amendment \[Protocol Version 3\]). Phase 2b portion: The Phase 2b study consists of a 4-week Screening Period and a 16-week Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately 180 subjects with PN, experiencing severe pruritus, are randomized (at 1:1:1:1 ratio) into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug are administered during the Double-Blind Period to measure the efficacy, safety, and PK of Vixarelimab. After the Double-Blind Period, all subjects have the option to receive vixarelimab during the OLE Period to evaluate the long-term safety and PK.
Interventions
DRUGVixarelimab
solution for injection
DRUGPlacebo
solution for injection
Sponsors
Kiniksa Pharmaceuticals, Ltd.
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Phase 2a: 2 arms; Phase 2b: 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(apply to both Phase 2a and Phase 2b unless otherwise specified): 1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b) 2. Have clinical diagnosis of prurigo nodularis for at least 6 months 3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1 4. Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b) 5. Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration 6. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
Exclusion criteria
(apply to both Phase 2a and Phase 2b unless otherwise specified): 1. Use of prohibited medications within the indicated timeframe from Day 1 2. Is currently using medication known to cause pruritus 3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor 4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit 5. Has an active infection, including skin infection 6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the subject at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | at Week 8 (Phase 2a); at Week 16 (Phase 2b) | Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Baseline, Week 8 | At every visit, participants rated the intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). |
| Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). |
| Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult). |
| Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep). |
| Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL. |
| Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL. |
| Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
| Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Estimate of Hardness of Nodules Over the Whole Body score: 0=No nodules are hard; 1=Up to one-third of nodules are hard; 2=One-third to two-thirds of nodules are hard; and 3=More than two-thirds of nodules are hard. A higher score indicates worse disease. |
| Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Extent of Excoriations over the Whole Body score: 0=No nodules are excoriated; 1=Up to one-third of nodules are excoriated; 2=One-third to two-thirds of nodules are excoriated; and 3=More than two-thirds of nodules are excoriated. A higher score indicates worse disease. |
| Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease). |
| Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | Baseline, Week 16 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | Baseline, Week 16 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 | Week 16 | PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease); 0 (clear) indicates no nodules and 1 (almost clear) indicates nodules are present, few of the nodules are moderately raised. |
| Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1 through 52 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1 through 52 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1 through 52 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1 through 52 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease); 0 (clear) indicates no nodules and 1 (almost clear) indicates nodules are present, few of the nodules are moderately raised. |
| Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease). |
| Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | IGA-CNPG-S is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe); 0 (clear) indicates no nodules and 1 (almost clear) indicates rare palpable pruriginous nodules (approximately 1-5 nodules). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state. |
| Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state. |
| Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). A score was set to missing after a participant received prohibited/rescue medication that potentially impact efficacy analyses prior to Week 16, and the participant's worst post baseline observation before the time of the medication usage was carried forward (WOCF) to impute missing endpoint value (for participants whose postbaseline values were all missing, the baseline was used to impute). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). A score was set to missing after a participant received prohibited/rescue medication that potentially impact efficacy analyses prior to Week 16, and the participant's worst post baseline observation before the time of the medication usage was carried forward (WOCF) to impute missing endpoint value (for participants whose postbaseline values were all missing, the baseline was used to impute). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2b: Change From Baseline in ItchyQoL Over Time | Baseline, Weeks 4, 8, 12, 16, 18, 20, 32, 48, 52 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Baseline, Weeks 4, 8, 12, 16, 18, 20, 32, 48, 52 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Number of Nodules over the Whole Body score: 0=0 nodules; 1=1 to 9 nodules; 2=10 to 50 nodules; and 3=more than 50 nodules. A higher score indicates worse disease. |
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Poland, South Korea, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
Participants were randomized 1:1 to receive vixarelimab or placebo in Phase 2a. In Phase 2b, participants were randomized 1:1:1:1:1 to receive 4 different dosing regimens of vixarelimab or placebo in a 16-week Double-Blind Period followed by a 36-week Open-Label-Extension (OLE) Period.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW Vixarelimab 720 mg loading dose followed by 360 mg subcutaneously (SC) weekly (QW) for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2). | 23 |
| Phase 2a - Placebo SC QW Placebo loading dose followed by placebo SC QW for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2). | 26 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) Vixarelimab 540 mg SC, every 4 weeks (Q4W) for 16 weeks during the double blind (DBL) period. Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during open label extension (OLE). | 47 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) Vixarelimab 360 mg SC, Q4W for 16 weeks during the double blind (DBL) period. Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during open label extension (OLE). | 47 |
| Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) Vixarelimab 120 mg SC, Q4W for 16 weeks during double blind (DBL) period. Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during open label extension (OLE). | 47 |
| Phase 2b - Placebo SC, Q4W (DBL), Then Vixarelimab (OLE) Placebo SC, Q4W for 16 weeks during double blind (DBL) period. Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during open label extension (OLE). | 48 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Double-Blind Period | Adverse Event | 0 | 0 | 2 | 0 | 0 | 0 |
| Double-Blind Period | Coronavirus Disease (COVID-19) | 0 | 0 | 0 | 0 | 0 | 1 |
| Double-Blind Period | Lost to Follow-up | 2 | 0 | 0 | 0 | 0 | 1 |
| Double-Blind Period | Other | 1 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Period | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 |
| Double-Blind Period | Withdrawal by Subject | 1 | 2 | 0 | 2 | 0 | 0 |
| Open-Label Period (Phase 2b Only) | Adverse Event | 0 | 0 | 2 | 2 | 2 | 1 |
| Open-Label Period (Phase 2b Only) | Lack of Efficacy | 0 | 0 | 1 | 0 | 3 | 0 |
| Open-Label Period (Phase 2b Only) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 |
| Open-Label Period (Phase 2b Only) | Other | 0 | 0 | 0 | 0 | 0 | 1 |
| Open-Label Period (Phase 2b Only) | Withdrawal by Subject | 0 | 0 | 4 | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Phase 2a - Placebo SC QW | Total | Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | Phase 2b - Placebo SC, Q4W (DBL), Then Vixarelimab (OLE) | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) |
|---|---|---|---|---|---|---|---|
| Age, Continuous Phase 2a | 64.1 years STANDARD_DEVIATION 7.86 | 58.4 years STANDARD_DEVIATION 13.41 | 52.0 years STANDARD_DEVIATION 15.56 | — | — | — | — |
| Age, Continuous Phase 2b | — | 55.4 years STANDARD_DEVIATION 13.83 | — | 54.4 years STANDARD_DEVIATION 16.11 | 54.8 years STANDARD_DEVIATION 13.35 | 56.7 years STANDARD_DEVIATION 12.18 | 55.9 years STANDARD_DEVIATION 13.73 |
| Ethnicity (NIH/OMB) Phase 2a Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Phase 2a Not Hispanic or Latino | 26 Participants | 47 Participants | 21 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Phase 2a Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Phase 2b Hispanic or Latino | — | 12 Participants | — | 4 Participants | 3 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Phase 2b Not Hispanic or Latino | — | 177 Participants | — | 43 Participants | 45 Participants | 47 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Phase 2b Unknown or Not Reported | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Phase 2a American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a Asian | 0 Participants | 2 Participants | 2 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a Black or African American | 3 Participants | 8 Participants | 5 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a More than one race | 0 Participants | 1 Participants | 1 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2a White | 21 Participants | 36 Participants | 15 Participants | — | — | — | — |
| Race (NIH/OMB) Phase 2b American Indian or Alaska Native | — | 4 Participants | — | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Phase 2b Asian | — | 34 Participants | — | 3 Participants | 11 Participants | 9 Participants | 11 Participants |
| Race (NIH/OMB) Phase 2b Black or African American | — | 22 Participants | — | 8 Participants | 6 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Phase 2b More than one race | — | 2 Participants | — | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Phase 2b Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Phase 2b Unknown or Not Reported | — | 6 Participants | — | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Phase 2b White | — | 121 Participants | — | 34 Participants | 29 Participants | 31 Participants | 27 Participants |
| Sex: Female, Male Phase 2a Female | 16 Participants | 29 Participants | 13 Participants | — | — | — | — |
| Sex: Female, Male Phase 2a Male | 10 Participants | 20 Participants | 10 Participants | — | — | — | — |
| Sex: Female, Male Phase 2b Female | — | 114 Participants | — | 28 Participants | 29 Participants | 29 Participants | 28 Participants |
| Sex: Female, Male Phase 2b Male | — | 75 Participants | — | 19 Participants | 19 Participants | 18 Participants | 19 Participants |
| Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score at Baseline Phase 2a | 8.0 score on a scale STANDARD_DEVIATION 1.09 | 8.3 score on a scale STANDARD_DEVIATION 1.05 | 8.7 score on a scale STANDARD_DEVIATION 0.88 | — | — | — | — |
| Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score at Baseline Phase 2b | — | 8.5 score on a scale STANDARD_DEVIATION 0.98 | — | 8.4 score on a scale STANDARD_DEVIATION 1.17 | 8.6 score on a scale STANDARD_DEVIATION 0.89 | 8.4 score on a scale STANDARD_DEVIATION 0.93 | 8.7 score on a scale STANDARD_DEVIATION 0.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 26 | 0 / 47 | 0 / 47 | 0 / 47 | 0 / 48 | 0 / 181 |
| other Total, other adverse events | 17 / 23 | 14 / 26 | 18 / 47 | 13 / 47 | 10 / 47 | 14 / 48 | 77 / 181 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 | 3 / 47 | 0 / 47 | 1 / 47 | 3 / 48 | 8 / 181 |
Outcome results
Primary
Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score
Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: at Week 8 (Phase 2a); at Week 16 (Phase 2b)
Population: Modified Intent to Treat (mITT) Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Part 2a: Last Observation Carried Forward (LOCF); Part 2b: Multiple imputation (WI)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -50.6 percentage change | Standard Error 6.99 |
| Phase 2a - Placebo SC QW | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -29.4 percentage change | Standard Error 6.8 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -56.2 percentage change | Standard Error 4.84 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -51.0 percentage change | Standard Error 4.83 |
| Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -33.0 percentage change | Standard Error 4.86 |
| Phase 2b - Placebo SC, Q4W (DBL), Then Vixarelimab (OLE) | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | -14.5 percentage change | Standard Error 4.76 |
p-value: 0.034795% CI: [-40.82, -1.6]ANCOVA
p-value: <0.000195% CI: [-54.9, -28.5]ANCOVA
p-value: <0.000195% CI: [-49.6, 23.3]ANCOVA
p-value: 0.006195% CI: [-31.6, -5.3]ANCOVA
Secondary
Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus).
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 8 | -7.7 score on a scale | Standard Error 1.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 14 | -7.1 score on a scale | Standard Error 1.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 6 | -7.2 score on a scale | Standard Error 1.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 16 | -7.5 score on a scale | Standard Error 1.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 10 | -7.7 score on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 18 | -6.8 score on a scale | Standard Error 1.6 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 4 | -6.7 score on a scale | Standard Error 1.12 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 20 | -6.8 score on a scale | Standard Error 1.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 12 | -7.4 score on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 24 | -7.9 score on a scale | Standard Error 1.82 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 2 | -5.8 score on a scale | Standard Error 0.95 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 24 | -3.7 score on a scale | Standard Error 1.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 2 | -2.7 score on a scale | Standard Error 0.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 4 | -3.9 score on a scale | Standard Error 0.76 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 6 | -4.2 score on a scale | Standard Error 0.76 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 8 | -4.3 score on a scale | Standard Error 0.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 10 | -5.0 score on a scale | Standard Error 0.77 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 12 | -4.8 score on a scale | Standard Error 0.83 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 14 | -4.7 score on a scale | Standard Error 1.13 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 16 | -4.6 score on a scale | Standard Error 0.72 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 18 | -3.4 score on a scale | Standard Error 1.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Week 20 | -3.5 score on a scale | Standard Error 1.4 |
Secondary
Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Estimate of Hardness of Nodules Over the Whole Body score: 0=No nodules are hard; 1=Up to one-third of nodules are hard; 2=One-third to two-thirds of nodules are hard; and 3=More than two-thirds of nodules are hard. A higher score indicates worse disease.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 8 | -0.7 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 14 | -1.2 score on a scale | Standard Error 0.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 6 | -0.6 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 16 | -1.1 score on a scale | Standard Error 0.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 10 | -1.1 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 18 | -1.2 score on a scale | Standard Error 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 4 | -0.5 score on a scale | Standard Error 0.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 20 | -1.3 score on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 12 | -1.0 score on a scale | Standard Error 0.22 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 24 | -1.2 score on a scale | Standard Error 0.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 2 | -0.2 score on a scale | Standard Error 0.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 24 | -0.8 score on a scale | Standard Error 0.18 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 2 | -0.2 score on a scale | Standard Error 0.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 4 | -0.4 score on a scale | Standard Error 0.15 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 6 | -0.5 score on a scale | Standard Error 0.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 8 | -0.6 score on a scale | Standard Error 0.17 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 10 | -0.8 score on a scale | Standard Error 0.17 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 12 | -0.8 score on a scale | Standard Error 0.19 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 14 | -0.9 score on a scale | Standard Error 0.25 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 16 | -0.8 score on a scale | Standard Error 0.2 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 18 | -0.9 score on a scale | Standard Error 0.26 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body | Week 20 | -1.2 score on a scale | Standard Error 0.24 |
Secondary
Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Extent of Excoriations over the Whole Body score: 0=No nodules are excoriated; 1=Up to one-third of nodules are excoriated; 2=One-third to two-thirds of nodules are excoriated; and 3=More than two-thirds of nodules are excoriated. A higher score indicates worse disease.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 8 | -0.4 score on a scale | Standard Error 0.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 14 | -1.0 score on a scale | Standard Error 0.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 6 | -0.6 score on a scale | Standard Error 0.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 16 | -1.1 score on a scale | Standard Error 0.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 10 | -0.7 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 18 | -1.0 score on a scale | Standard Error 0.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 4 | -0.5 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 20 | -1.0 score on a scale | Standard Error 0.33 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 12 | -0.8 score on a scale | Standard Error 0.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 24 | -0.8 score on a scale | Standard Error 0.29 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 2 | -0.2 score on a scale | Standard Error 0.14 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 24 | -0.8 score on a scale | Standard Error 0.27 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 2 | -0.2 score on a scale | Standard Error 0.1 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 4 | -0.7 score on a scale | Standard Error 0.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 6 | -0.7 score on a scale | Standard Error 0.17 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 8 | -0.7 score on a scale | Standard Error 0.17 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 10 | -0.8 score on a scale | Standard Error 0.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 12 | -0.8 score on a scale | Standard Error 0.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 14 | -1.0 score on a scale | Standard Error 0.23 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 16 | -0.7 score on a scale | Standard Error 0.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 18 | -1.0 score on a scale | Standard Error 0.25 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body | Week 20 | -1.1 score on a scale | Standard Error 0.26 |
Secondary
Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. The first three components (number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriations over the whole body) were analyzed as secondary endpoints. For the Number of Nodules over the Whole Body score: 0=0 nodules; 1=1 to 9 nodules; 2=10 to 50 nodules; and 3=more than 50 nodules. A higher score indicates worse disease.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 8 | -0.5 score on a scale | Standard Error 0.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 14 | -0.9 score on a scale | Standard Error 0.28 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 6 | -0.5 score on a scale | Standard Error 0.14 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 16 | -1.0 score on a scale | Standard Error 0.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 10 | -0.5 score on a scale | Standard Error 0.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 18 | -0.9 score on a scale | Standard Error 0.28 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 4 | -0.4 score on a scale | Standard Error 0.14 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 20 | -0.9 score on a scale | Standard Error 0.28 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 12 | -0.7 score on a scale | Standard Error 0.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 24 | -0.9 score on a scale | Standard Error 0.28 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 2 | -0.2 score on a scale | Standard Error 0.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 24 | -0.5 score on a scale | Standard Error 0.15 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 2 | -0.1 score on a scale | Standard Error 0.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 4 | -0.2 score on a scale | Standard Error 0.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 6 | -0.2 score on a scale | Standard Error 0.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 8 | -0.3 score on a scale | Standard Error 0.11 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 10 | -0.3 score on a scale | Standard Error 0.09 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 12 | -0.4 score on a scale | Standard Error 0.11 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 14 | -0.5 score on a scale | Standard Error 0.14 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 16 | -0.3 score on a scale | Standard Error 0.09 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 18 | -0.5 score on a scale | Standard Error 0.15 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score | Week 20 | -0.4 score on a scale | Standard Error 0.15 |
Secondary
Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time
Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 6 | -4.7 units on a scale | Standard Error 0.75 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 11 | -4.7 units on a scale | Standard Error 1.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 4 | -4.5 units on a scale | Standard Error 0.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 12 | -4.8 units on a scale | Standard Error 0.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 7 | -5.0 units on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 13 | -4.6 units on a scale | Standard Error 1.2 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 3 | -3.5 units on a scale | Standard Error 0.63 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 14 | -4.8 units on a scale | Standard Error 1.1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 8 | -5.0 units on a scale | Standard Error 0.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 15 | -4.5 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 5 | -4.5 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 16 | -5.1 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 9 | -4.3 units on a scale | Standard Error 1.08 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 18 | -4.8 units on a scale | Standard Error 1.14 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 2 | -2.9 units on a scale | Standard Error 0.62 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 20 | -4.6 units on a scale | Standard Error 1.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 10 | -5.0 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 24 | -4.9 units on a scale | Standard Error 1.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 1 | -1.9 units on a scale | Standard Error 0.55 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 24 | -2.9 units on a scale | Standard Error 0.8 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 1 | -1.4 units on a scale | Standard Error 0.33 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 2 | -1.8 units on a scale | Standard Error 0.51 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 3 | -2.2 units on a scale | Standard Error 0.52 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 4 | -3.3 units on a scale | Standard Error 0.58 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 5 | -2.7 units on a scale | Standard Error 0.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 6 | -2.9 units on a scale | Standard Error 0.54 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 7 | -3.2 units on a scale | Standard Error 0.56 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 8 | -3.0 units on a scale | Standard Error 0.48 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 9 | -3.8 units on a scale | Standard Error 0.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 10 | -3.7 units on a scale | Standard Error 0.49 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 11 | -4.3 units on a scale | Standard Error 0.58 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 12 | -3.8 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 13 | -3.5 units on a scale | Standard Error 0.64 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 14 | -3.7 units on a scale | Standard Error 0.68 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 15 | -3.9 units on a scale | Standard Error 0.69 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 16 | -3.3 units on a scale | Standard Error 0.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 18 | -3.0 units on a scale | Standard Error 0.67 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 20 | -2.9 units on a scale | Standard Error 0.74 |
Secondary
Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).
Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 6 | -27.6 units on a scale | Standard Error 4.6 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 12 | -26.0 units on a scale | Standard Error 7.57 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 4 | -25.3 units on a scale | Standard Error 4.32 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 16 | -29.6 units on a scale | Standard Error 4.96 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 8 | -30.0 units on a scale | Standard Error 4.8 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 24 | -26.3 units on a scale | Standard Error 8.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 2 | -16.3 units on a scale | Standard Error 3.18 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 24 | -19.1 units on a scale | Standard Error 5.15 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 2 | -6.2 units on a scale | Standard Error 1.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 4 | -11.0 units on a scale | Standard Error 2.22 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 6 | -14.5 units on a scale | Standard Error 2.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 8 | -16.0 units on a scale | Standard Error 2.54 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 12 | -18.1 units on a scale | Standard Error 3.51 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Week 16 | -15.8 units on a scale | Standard Error 2.49 |
Secondary
Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time
QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL.
Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 6 | -8.9 score on a scale | Standard Error 1.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 12 | -6.8 score on a scale | Standard Error 2.22 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 4 | -8.3 score on a scale | Standard Error 1.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 16 | -8.1 score on a scale | Standard Error 1.64 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 8 | -9.4 score on a scale | Standard Error 1.62 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 24 | -7.0 score on a scale | Standard Error 2.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 2 | -6.7 score on a scale | Standard Error 1.23 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 24 | -7.3 score on a scale | Standard Error 1.92 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 2 | -2.8 score on a scale | Standard Error 0.82 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 4 | -4.5 score on a scale | Standard Error 0.87 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 6 | -6.1 score on a scale | Standard Error 0.85 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 8 | -6.3 score on a scale | Standard Error 0.94 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 12 | -7.3 score on a scale | Standard Error 1.33 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Week 16 | -6.9 score on a scale | Standard Error 0.88 |
Secondary
Phase 2a: Change From Baseline in Sleep Loss VAS Over Time
Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 10 | -4.8 units on a scale | Standard Error 0.74 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 3 | -3.3 units on a scale | Standard Error 0.63 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 11 | -4.0 units on a scale | Standard Error 1.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 6 | -4.1 units on a scale | Standard Error 0.73 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 12 | -4.3 units on a scale | Standard Error 0.64 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 2 | -2.8 units on a scale | Standard Error 0.58 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 13 | -4.1 units on a scale | Standard Error 1.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 7 | -4.8 units on a scale | Standard Error 0.73 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 14 | -4.1 units on a scale | Standard Error 1.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 4 | -3.9 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 15 | -3.9 units on a scale | Standard Error 1.21 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 8 | -4.5 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 16 | -4.4 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 1 | -2.0 units on a scale | Standard Error 0.54 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 18 | -4.3 units on a scale | Standard Error 1.2 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 9 | -4.3 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 20 | -4.0 units on a scale | Standard Error 1.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 24 | -4.3 units on a scale | Standard Error 1.2 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 5 | -4.2 units on a scale | Standard Error 0.71 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 24 | -2.6 units on a scale | Standard Error 1.07 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 1 | -1.5 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 2 | -1.2 units on a scale | Standard Error 0.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 3 | -1.4 units on a scale | Standard Error 0.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 4 | -2.5 units on a scale | Standard Error 0.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 5 | -2.3 units on a scale | Standard Error 0.59 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 6 | -1.7 units on a scale | Standard Error 0.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 7 | -2.4 units on a scale | Standard Error 0.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 8 | -2.5 units on a scale | Standard Error 0.53 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 9 | -3.1 units on a scale | Standard Error 0.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 10 | -2.7 units on a scale | Standard Error 0.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 11 | -3.8 units on a scale | Standard Error 0.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 12 | -3.1 units on a scale | Standard Error 0.55 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 13 | -2.7 units on a scale | Standard Error 0.82 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 14 | -3.1 units on a scale | Standard Error 0.85 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 15 | -3.2 units on a scale | Standard Error 0.9 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 16 | -2.8 units on a scale | Standard Error 0.59 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 18 | -2.9 units on a scale | Standard Error 0.81 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Week 20 | -2.8 units on a scale | Standard Error 0.97 |
Secondary
Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 2 | -1.9 units on a scale | Standard Error 0.46 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 13 | -3.6 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 7 | -3.7 units on a scale | Standard Error 0.73 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 14 | -3.5 units on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 4 | -3.2 units on a scale | Standard Error 0.63 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 15 | -3.6 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 8 | -3.8 units on a scale | Standard Error 0.74 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 16 | -3.6 units on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 1 | -1.3 units on a scale | Standard Error 0.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 17 | -3.0 units on a scale | Standard Error 1.14 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 9 | -3.6 units on a scale | Standard Error 0.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 18 | -3.3 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 5 | -3.5 units on a scale | Standard Error 0.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 10 | -3.6 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 20 | -3.4 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 3 | -2.6 units on a scale | Standard Error 0.54 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 21 | -3.4 units on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 11 | -3.5 units on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 22 | -3.4 units on a scale | Standard Error 1.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 6 | -3.7 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 23 | -3.4 units on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 12 | -3.4 units on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 24 | -3.3 units on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 19 | -3.3 units on a scale | Standard Error 1.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 24 | -3.2 units on a scale | Standard Error 0.84 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 1 | -0.9 units on a scale | Standard Error 0.3 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 2 | -1.7 units on a scale | Standard Error 0.34 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 3 | -2.1 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 4 | -2.4 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 5 | -2.7 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 6 | -2.9 units on a scale | Standard Error 0.4 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 7 | -3.0 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 8 | -3.1 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 9 | -3.2 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 10 | -3.3 units on a scale | Standard Error 0.39 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 11 | -3.4 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 12 | -3.2 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 13 | -3.2 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 14 | -3.0 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 15 | -3.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 16 | -3.2 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 17 | -2.9 units on a scale | Standard Error 0.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 18 | -2.9 units on a scale | Standard Error 0.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 19 | -2.9 units on a scale | Standard Error 0.76 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 20 | -3.0 units on a scale | Standard Error 0.83 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 21 | -3.1 units on a scale | Standard Error 0.83 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 22 | -2.8 units on a scale | Standard Error 0.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 23 | -3.1 units on a scale | Standard Error 0.83 |
Secondary
Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 2 | -1.9 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 13 | -3.5 units on a scale | Standard Error 0.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 7 | -3.8 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 14 | -3.6 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 4 | -3.1 units on a scale | Standard Error 0.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 15 | -3.7 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 8 | -3.8 units on a scale | Standard Error 0.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 16 | -3.7 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 1 | -1.4 units on a scale | Standard Error 0.38 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 17 | -2.6 units on a scale | Standard Error 1.1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 18 | -3.1 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 9 | -3.5 units on a scale | Standard Error 0.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 19 | -3.2 units on a scale | Standard Error 1.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 5 | -3.4 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 20 | -3.0 units on a scale | Standard Error 1.14 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 10 | -3.6 units on a scale | Standard Error 0.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 21 | -3.3 units on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 3 | -2.6 units on a scale | Standard Error 0.55 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 22 | -3.2 units on a scale | Standard Error 1.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 11 | -3.4 units on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 23 | -3.2 units on a scale | Standard Error 1.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 6 | -3.6 units on a scale | Standard Error 0.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 24 | -3.3 units on a scale | Standard Error 1.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 12 | -3.3 units on a scale | Standard Error 0.67 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 24 | -2.7 units on a scale | Standard Error 0.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 1 | -0.8 units on a scale | Standard Error 0.26 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 2 | -1.5 units on a scale | Standard Error 0.33 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 3 | -1.7 units on a scale | Standard Error 0.35 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 4 | -2.1 units on a scale | Standard Error 0.36 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 5 | -2.2 units on a scale | Standard Error 0.39 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 6 | -2.4 units on a scale | Standard Error 0.39 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 7 | -2.5 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 8 | -2.6 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 9 | -2.8 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 10 | -2.8 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 11 | -3.1 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 12 | -2.9 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 13 | -3.0 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 14 | -2.9 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 15 | -3.0 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 16 | -3.1 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 18 | -2.9 units on a scale | Standard Error 0.79 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 19 | -2.8 units on a scale | Standard Error 0.77 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 20 | -2.9 units on a scale | Standard Error 0.84 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 21 | -2.8 units on a scale | Standard Error 0.86 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 22 | -2.8 units on a scale | Standard Error 0.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 23 | -2.8 units on a scale | Standard Error 0.84 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 17 | -2.7 units on a scale | Standard Error 0.79 |
Secondary
Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -2.4 score on a scale | Standard Error 0.47 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -4.2 score on a scale | Standard Error 0.67 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -4.5 score on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -4.4 score on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -3.7 score on a scale | Standard Error 0.62 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -4.3 score on a scale | Standard Error 0.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -4.5 score on a scale | Standard Error 0.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -4.3 score on a scale | Standard Error 0.64 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -1.6 score on a scale | Standard Error 0.36 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -3.8 score on a scale | Standard Error 1.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -4.2 score on a scale | Standard Error 0.65 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -4.2 score on a scale | Standard Error 0.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -4.4 score on a scale | Standard Error 1.02 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -4.2 score on a scale | Standard Error 0.62 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -4.3 score on a scale | Standard Error 1.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -2.9 score on a scale | Standard Error 0.52 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -4.3 score on a scale | Standard Error 1.03 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -4.0 score on a scale | Standard Error 0.65 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -4.4 score on a scale | Standard Error 1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -4.3 score on a scale | Standard Error 0.64 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -4.4 score on a scale | Standard Error 1.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -3.9 score on a scale | Standard Error 0.63 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -4.3 score on a scale | Standard Error 1.03 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -4.3 score on a scale | Standard Error 1.05 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -2.9 score on a scale | Standard Error 0.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -0.8 score on a scale | Standard Error 0.29 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -1.3 score on a scale | Standard Error 0.3 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -1.9 score on a scale | Standard Error 0.37 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -2.3 score on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -2.6 score on a scale | Standard Error 0.39 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -2.6 score on a scale | Standard Error 0.37 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -2.8 score on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -2.7 score on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -2.8 score on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -2.9 score on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -3.2 score on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -2.9 score on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -2.8 score on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -2.7 score on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -2.9 score on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -3.0 score on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -3.1 score on a scale | Standard Error 0.64 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -3.2 score on a scale | Standard Error 0.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -3.3 score on a scale | Standard Error 0.62 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -3.6 score on a scale | Standard Error 0.69 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -3.4 score on a scale | Standard Error 0.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -3.1 score on a scale | Standard Error 0.66 |
| Phase 2a - Placebo SC QW | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -3.1 score on a scale | Standard Error 0.72 |
Secondary
Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Week 8
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | 52.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | 30.8 percentage of participants |
p-value: 0.109395% CI: [0.81, 9.44]Cochran-Mantel-Haenszel
Secondary
Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 26.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 39.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 17.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 47.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 47.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 47.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 52.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 36.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 50.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 50.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 60.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 33.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 7.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 26.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 7.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 33.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 11.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 30.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 23.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 25.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 23.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 30.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 26.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 41.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 34.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 42.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 30.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 41.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 30.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 41.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 34.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 50.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 34.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 33.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 34.6 percentage of participants |
Comparison: Week 1p-value: 0.247495% CI: [0.43, 20.56]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.068795% CI: [0.83, 24.27]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.014595% CI: [1.38, 34.48]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.023595% CI: [1.24, 18.89]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.033495% CI: [1.09, 13.26]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.061895% CI: [0.95, 11.32]Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.174895% CI: [0.7, 8.15]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.109395% CI: [0.81, 9.44]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: 0.109395% CI: [0.81, 9.44]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.26195% CI: [0.6, 6.8]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: 0.286795% CI: [0.59, 5.71]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.287495% CI: [0.59, 6.01]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: 0.052795% CI: [0.94, 10.05]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.093695% CI: [0.82, 8.73]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: 0.08395% CI: [0.84, 10.21]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.378695% CI: [0.53, 5.33]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: 0.694995% CI: [0.12, 3.99]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.528895% CI: [0.31, 10.66]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.261395% CI: [0.43, 23.37]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.420895% CI: [0.34, 14.81]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.788495% CI: [0.2, 8.76]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.298295% CI: [0.45, 16.04]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.261395% CI: [0.43, 23.37]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.420895% CI: [0.34, 14.81]Cochran-Mantel-Haenszel
Secondary
Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease).
Time frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 8 | 43.5 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 14 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 6 | 43.5 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 16 | 59.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 10 | 40.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 18 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 4 | 13.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 20 | 70.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 12 | 50.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 24 | 50.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 2 | 8.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 24 | 8.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 2 | 7.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 4 | 7.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 6 | 11.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 8 | 15.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 10 | 19.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 12 | 23.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 14 | 35.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 16 | 26.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 18 | 16.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time | Week 20 | 16.7 percentage of participants |
Comparison: Week 2p-value: 0.843695% CI: [0.16, 9.64]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.492295% CI: [0.29, 13.75]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.006495% CI: [1.61, 36.91]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.020195% CI: [1.26, 20.91]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.084195% CI: [0.82, 10.55]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.029295% CI: [1.12, 15.22]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.225995% CI: [0.51, 15]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.010495% CI: [1.41, 20.95]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.043495% CI: [0.89, 214.44]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0093Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.02995% CI: [1.1, 189.25]Cochran-Mantel-Haenszel
Secondary
Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 8 | -36.8 percentage change | Standard Error 5.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 14 | -35.1 percentage change | Standard Error 7.28 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 6 | -34.2 percentage change | Standard Error 4.65 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 16 | -35.0 percentage change | Standard Error 4.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 10 | -36.2 percentage change | Standard Error 4.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 18 | -30.5 percentage change | Standard Error 7.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 4 | -31.8 percentage change | Standard Error 4.83 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 20 | -34.1 percentage change | Standard Error 8.05 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 12 | -33.7 percentage change | Standard Error 4.9 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 24 | -36.6 percentage change | Standard Error 8.92 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 2 | -26.8 percentage change | Standard Error 3.83 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 24 | -20.5 percentage change | Standard Error 8.19 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 2 | -13.3 percentage change | Standard Error 3.75 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 4 | -21.7 percentage change | Standard Error 4.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 6 | -23.6 percentage change | Standard Error 4.56 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 8 | -24.2 percentage change | Standard Error 4.95 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 10 | -26.4 percentage change | Standard Error 4.52 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 12 | -25.0 percentage change | Standard Error 4.71 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 14 | -26.0 percentage change | Standard Error 6.21 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 16 | -24.5 percentage change | Standard Error 4.49 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 18 | -18.1 percentage change | Standard Error 7.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Week 20 | -19.4 percentage change | Standard Error 7.39 |
Comparison: Week 2p-value: 0.014995% CI: [-24.22, -2.76]ANCOVA
Comparison: Week 4p-value: 0.139995% CI: [-23.67, 3.44]ANCOVA
Comparison: Week 6p-value: 0.107895% CI: [-23.68, 2.42]ANCOVA
Comparison: Week 8p-value: 0.079895% CI: [-26.72, 1.56]ANCOVA
Comparison: Week 10p-value: 0.140595% CI: [-22.83, 3.34]ANCOVA
Comparison: Week 12p-value: 0.202695% CI: [-22.43, 4.9]ANCOVA
Comparison: Week 14p-value: 0.364695% CI: [-29.52, 11.37]ANCOVA
Comparison: Week 16p-value: 0.110695% CI: [-23.52, 2.5]ANCOVA
Comparison: Week 18p-value: 0.262395% CI: [-35.11, 10.2]ANCOVA
Comparison: Week 20p-value: 0.209595% CI: [-38.27, 9.03]ANCOVA
Comparison: Week 24p-value: 0.212795% CI: [-42.3, 10.13]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time
Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 6 | -50.0 percentage change | Standard Error 7.81 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 11 | -50.5 percentage change | Standard Error 10.59 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 4 | -48.9 percentage change | Standard Error 7.6 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 12 | -53.4 percentage change | Standard Error 6.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 7 | -54.3 percentage change | Standard Error 7.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 13 | -48.3 percentage change | Standard Error 10.88 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 3 | -36.8 percentage change | Standard Error 6.53 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 14 | -50.4 percentage change | Standard Error 10.25 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 8 | -54.4 percentage change | Standard Error 7.03 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 15 | -46.0 percentage change | Standard Error 10.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 5 | -47.5 percentage change | Standard Error 6.88 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 16 | -56.5 percentage change | Standard Error 6.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 9 | -42.5 percentage change | Standard Error 9.51 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 18 | -50.2 percentage change | Standard Error 11.56 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 2 | -28.2 percentage change | Standard Error 6.74 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 20 | -48.8 percentage change | Standard Error 12.47 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 10 | -54.0 percentage change | Standard Error 6.92 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 24 | -50.4 percentage change | Standard Error 12.32 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 1 | -18.4 percentage change | Standard Error 5.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 24 | -36.6 percentage change | Standard Error 11.11 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 1 | -15.8 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 2 | -18.3 percentage change | Standard Error 6.67 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 3 | -19.2 percentage change | Standard Error 6.46 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 4 | -33.1 percentage change | Standard Error 7.52 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 5 | -27.9 percentage change | Standard Error 6.81 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 6 | -31.8 percentage change | Standard Error 7.73 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 7 | -33.6 percentage change | Standard Error 7.33 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 8 | -32.6 percentage change | Standard Error 6.96 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 9 | -47.2 percentage change | Standard Error 8.1 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 10 | -40.0 percentage change | Standard Error 6.71 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 11 | -51.2 percentage change | Standard Error 9.02 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 12 | -40.2 percentage change | Standard Error 6 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 13 | -43.0 percentage change | Standard Error 9.26 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 14 | -44.2 percentage change | Standard Error 8.73 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 15 | -47.6 percentage change | Standard Error 9.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 16 | -35.6 percentage change | Standard Error 6.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 18 | -39.3 percentage change | Standard Error 10.44 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Week 20 | -37.1 percentage change | Standard Error 11.26 |
Comparison: Week 1p-value: 0.737995% CI: [-17.98, 12.83]ANCOVA
Comparison: Week 2p-value: 0.302295% CI: [-28.9, 9.17]ANCOVA
Comparison: Week 3p-value: 0.060695% CI: [-36.07, 0.82]ANCOVA
Comparison: Week 4p-value: 0.144895% CI: [-37.28, 5.66]ANCOVA
Comparison: Week 5p-value: 0.04895% CI: [-39.06, -0.18]ANCOVA
Comparison: Week 6p-value: 0.103295% CI: [-40.3, 3.85]ANCOVA
Comparison: Week 7p-value: 0.052395% CI: [-41.66, 0.22]ANCOVA
Comparison: Week 8p-value: 0.032595% CI: [-41.62, -1.9]ANCOVA
Comparison: Week 9p-value: 0.727495% CI: [-22.83, 32.12]ANCOVA
Comparison: Week 10p-value: 0.152395% CI: [-33.47, 5.39]ANCOVA
Comparison: Week 11p-value: 0.964995% CI: [-29.93, 31.24]ANCOVA
Comparison: Week 12p-value: 0.135195% CI: [-30.48, 4.25]ANCOVA
Comparison: Week 13p-value: 0.725895% CI: [-36.75, 26.07]ANCOVA
Comparison: Week 14p-value: 0.664695% CI: [-35.81, 23.36]ANCOVA
Comparison: Week 15p-value: 0.915195% CI: [-29.2, 32.38]ANCOVA
Comparison: Week 16p-value: 0.030495% CI: [-39.66, -2.07]ANCOVA
Comparison: Week 18p-value: 0.520995% CI: [-45.96, 24.17]ANCOVA
Comparison: Week 20p-value: 0.525495% CI: [-49.46, 26.2]ANCOVA
Comparison: Week 24p-value: 0.445895% CI: [-51.16, 23.53]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8
At every visit, participants rated the intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Time frame: Baseline, Week 8
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | -54.4 percentage change | Standard Error 7.03 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | -32.6 percentage change | Standard Error 6.96 |
p-value: 0.032595% CI: [-41.62, -1.9]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time
QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL.
Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 6 | -54.1 percentage change | Standard Error 6.34 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 12 | -46.9 percentage change | Standard Error 10.33 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 4 | -50.4 percentage change | Standard Error 6.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 16 | -49.6 percentage change | Standard Error 6.51 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 8 | -55.4 percentage change | Standard Error 7.15 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 24 | -54.6 percentage change | Standard Error 12.86 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 2 | -40.0 percentage change | Standard Error 6.26 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 24 | -46.0 percentage change | Standard Error 11.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 2 | -12.0 percentage change | Standard Error 6.09 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 4 | -29.1 percentage change | Standard Error 5.93 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 6 | -41.7 percentage change | Standard Error 6.16 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 8 | -43.0 percentage change | Standard Error 6.95 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 12 | -46.1 percentage change | Standard Error 8.8 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Week 16 | -45.2 percentage change | Standard Error 6.23 |
Comparison: Week 2p-value: 0.001895% CI: [-44.96, -10.97]ANCOVA
Comparison: Week 4p-value: 0.012795% CI: [-37.83, -4.77]ANCOVA
Comparison: Week 6p-value: 0.154795% CI: [-29.54, 4.84]ANCOVA
Comparison: Week 8p-value: 0.204895% CI: [-31.78, 7.01]ANCOVA
Comparison: Week 12p-value: 0.950895% CI: [-29.28, 27.58]ANCOVA
Comparison: Week 16p-value: 0.61495% CI: [-22.07, 13.19]ANCOVA
Comparison: Week 24p-value: 0.620795% CI: [-44.94, 27.66]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 6 | -29.6 percentage change | Standard Error 3.99 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 12 | -29.7 percentage change | Standard Error 6.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 4 | -27.5 percentage change | Standard Error 3.78 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 16 | -32.2 percentage change | Standard Error 4.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 8 | -32.6 percentage change | Standard Error 4.25 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 24 | -29.8 percentage change | Standard Error 7.56 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 2 | -16.4 percentage change | Standard Error 2.6 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 24 | -22.0 percentage change | Standard Error 6.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 2 | -6.6 percentage change | Standard Error 2.53 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 4 | -14.1 percentage change | Standard Error 3.68 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 6 | -17.7 percentage change | Standard Error 3.89 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 8 | -18.8 percentage change | Standard Error 4.14 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 12 | -21.1 percentage change | Standard Error 5.37 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Week 16 | -17.1 percentage change | Standard Error 4.07 |
Comparison: Week 2p-value: 0.007995% CI: [-16.89, -2.71]ANCOVA
Comparison: Week 4p-value: 0.012295% CI: [-23.69, -3.06]ANCOVA
Comparison: Week 6p-value: 0.032895% CI: [-22.8, -1.02]ANCOVA
Comparison: Week 8p-value: 0.021295% CI: [-25.36, -2.15]ANCOVA
Comparison: Week 12p-value: 0.311295% CI: [-25.95, 8.72]ANCOVA
Comparison: Week 16p-value: 0.011395% CI: [-26.75, -3.61]ANCOVA
Comparison: Week 24p-value: 0.45495% CI: [-29.2, 13.68]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time
Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 6 | -40.1 percentage change | Standard Error 16.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 11 | -50.6 percentage change | Standard Error 13.53 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 4 | -44.9 percentage change | Standard Error 9.02 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 12 | -50.4 percentage change | Standard Error 7.85 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 7 | -53.8 percentage change | Standard Error 9.25 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 13 | -54.2 percentage change | Standard Error 14.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 3 | -25.1 percentage change | Standard Error 19.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 14 | -50.0 percentage change | Standard Error 13.52 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 8 | -56.3 percentage change | Standard Error 7.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 15 | -44.2 percentage change | Standard Error 16.22 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 5 | -48.5 percentage change | Standard Error 9.02 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 16 | -52.4 percentage change | Standard Error 9.11 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 9 | -45.1 percentage change | Standard Error 12.13 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 18 | -54.3 percentage change | Standard Error 12.93 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 2 | -25.5 percentage change | Standard Error 10.77 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 20 | -42.9 percentage change | Standard Error 15.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 10 | -56.9 percentage change | Standard Error 8.25 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 24 | -50.2 percentage change | Standard Error 19.88 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 1 | -22.0 percentage change | Standard Error 9.95 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 24 | -24.6 percentage change | Standard Error 18.2 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 1 | -13.1 percentage change | Standard Error 9.66 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 2 | -2.2 percentage change | Standard Error 10.46 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 3 | 2.5 percentage change | Standard Error 19.11 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 4 | -25.7 percentage change | Standard Error 8.75 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 5 | -22.6 percentage change | Standard Error 8.75 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 6 | -7.5 percentage change | Standard Error 15.62 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 7 | -25.7 percentage change | Standard Error 8.98 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 8 | -30.0 percentage change | Standard Error 7.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 9 | -38.0 percentage change | Standard Error 10.37 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 10 | -29.7 percentage change | Standard Error 7.87 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 11 | -43.5 percentage change | Standard Error 11.57 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 12 | -35.9 percentage change | Standard Error 7.48 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 13 | -29.4 percentage change | Standard Error 12.23 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 14 | -34.8 percentage change | Standard Error 11.56 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 15 | -31.4 percentage change | Standard Error 13.88 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 16 | -27.1 percentage change | Standard Error 8.69 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 18 | -37.7 percentage change | Standard Error 11.84 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Week 20 | -34.8 percentage change | Standard Error 13.97 |
Comparison: Week 1p-value: 0.517295% CI: [-36.42, 18.6]ANCOVA
Comparison: Week 2p-value: 0.122895% CI: [-53.02, 6.53]ANCOVA
Comparison: Week 3p-value: 0.312995% CI: [-81.95, 26.84]ANCOVA
Comparison: Week 4p-value: 0.127795% CI: [-44.11, 5.72]ANCOVA
Comparison: Week 5p-value: 0.042495% CI: [-50.76, -0.92]ANCOVA
Comparison: Week 6p-value: 0.146595% CI: [-77.08, 11.85]ANCOVA
Comparison: Week 7p-value: 0.031695% CI: [-53.71, -2.59]ANCOVA
Comparison: Week 8p-value: 0.016995% CI: [-47.63, -4.95]ANCOVA
Comparison: Week 9p-value: 0.664195% CI: [-40.8, 26.59]ANCOVA
Comparison: Week 10p-value: 0.019995% CI: [-49.94, -4.53]ANCOVA
Comparison: Week 11p-value: 0.69895% CI: [-44.67, 30.51]ANCOVA
Comparison: Week 12p-value: 0.183895% CI: [-36.05, 7.13]ANCOVA
Comparison: Week 13p-value: 0.207895% CI: [-64.5, 14.98]ANCOVA
Comparison: Week 14p-value: 0.40995% CI: [-52.72, 22.41]ANCOVA
Comparison: Week 15p-value: 0.55895% CI: [-57.92, 32.23]ANCOVA
Comparison: Week 16p-value: 0.048695% CI: [-50.3, -0.16]ANCOVA
Comparison: Week 18p-value: 0.361395% CI: [-54.06, 20.78]ANCOVA
Comparison: Week 20p-value: 0.704295% CI: [-52.24, 36.08]ANCOVA
Comparison: Week 24p-value: 0.360295% CI: [-83.17, 31.89]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 7 | -44.2 percentage change | Standard Error 8.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 2 | -24.2 percentage change | Standard Error 5.78 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 3 | -31.6 percentage change | Standard Error 6.15 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 4 | -39.2 percentage change | Standard Error 6.98 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 5 | -43.1 percentage change | Standard Error 7.58 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 6 | -44.0 percentage change | Standard Error 7.87 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 1 | -17.2 percentage change | Standard Error 5.2 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 8 | -45.4 percentage change | Standard Error 8.13 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 9 | -42.1 percentage change | Standard Error 8.1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 10 | -43.3 percentage change | Standard Error 7.53 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 11 | -41.2 percentage change | Standard Error 7.78 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 12 | -40.8 percentage change | Standard Error 7.72 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 13 | -44.5 percentage change | Standard Error 7.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 14 | -45.3 percentage change | Standard Error 7.33 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 15 | -46.2 percentage change | Standard Error 7.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 16 | -46.3 percentage change | Standard Error 7.51 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 17 | -41.5 percentage change | Standard Error 12.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 18 | -44.3 percentage change | Standard Error 12.62 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 19 | -44.7 percentage change | Standard Error 12.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 20 | -44.0 percentage change | Standard Error 12.84 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 21 | -46.1 percentage change | Standard Error 13.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 22 | -44.1 percentage change | Standard Error 12.68 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 23 | -43.9 percentage change | Standard Error 13.02 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 24 | -42.9 percentage change | Standard Error 12.82 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 23 | -40.1 percentage change | Standard Error 11.98 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 1 | -13.5 percentage change | Standard Error 5.02 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 13 | -39.2 percentage change | Standard Error 7.01 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 2 | -22.5 percentage change | Standard Error 5.58 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 19 | -38.6 percentage change | Standard Error 11.65 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 3 | -25.8 percentage change | Standard Error 5.94 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 14 | -36.5 percentage change | Standard Error 7.08 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 4 | -30.8 percentage change | Standard Error 6.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 22 | -36.9 percentage change | Standard Error 11.67 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 5 | -35.1 percentage change | Standard Error 7.32 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 15 | -37.2 percentage change | Standard Error 7.05 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 6 | -37.9 percentage change | Standard Error 7.6 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 20 | -40.3 percentage change | Standard Error 11.81 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 7 | -39.0 percentage change | Standard Error 7.77 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 16 | -40.4 percentage change | Standard Error 7.25 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 8 | -39.1 percentage change | Standard Error 7.85 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 24 | -41.5 percentage change | Standard Error 11.8 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 9 | -41.0 percentage change | Standard Error 7.83 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 17 | -39.0 percentage change | Standard Error 12.18 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 10 | -43.3 percentage change | Standard Error 7.27 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 21 | -41.4 percentage change | Standard Error 12.3 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 11 | -43.7 percentage change | Standard Error 7.51 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 18 | -37.8 percentage change | Standard Error 11.61 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Week 12 | -40.0 percentage change | Standard Error 7.45 |
Comparison: Week 1p-value: 0.589695% CI: [-17.83, 10.26]ANCOVA
Comparison: Week 2p-value: 0.829295% CI: [-17.29, 13.93]ANCOVA
Comparison: Week 3p-value: 0.485295% CI: [-22.39, 10.8]ANCOVA
Comparison: Week 4p-value: 0.373195% CI: [-27.24, 10.42]ANCOVA
Comparison: Week 5p-value: 0.43695% CI: [-28.44, 12.48]ANCOVA
Comparison: Week 6p-value: 0.565595% CI: [-27.36, 15.15]ANCOVA
Comparison: Week 7p-value: 0.630295% CI: [-26.93, 16.49]ANCOVA
Comparison: Week 8p-value: 0.567195% CI: [-28.23, 15.67]ANCOVA
Comparison: Week 9p-value: 0.93595% CI: [-22.93, 29.83]ANCOVA
Comparison: Week 10p-value: 0.998295% CI: [-20.3, 20.34]ANCOVA
Comparison: Week 11p-value: 0.810295% CI: [-18.48, 23.51]ANCOVA
Comparison: Week 12p-value: 0.933495% CI: [-21.7, 19.97]ANCOVA
Comparison: Week 13p-value: 0.587395% CI: [-24.92, 14.29]ANCOVA
Comparison: Week 14p-value: 0.373795% CI: [-28.61, 10.96]ANCOVA
Comparison: Week 15p-value: 0.363195% CI: [-28.7, 10.72]ANCOVA
Comparison: Week 16p-value: 0.558595% CI: [-26.2, 14.34]ANCOVA
Comparison: Week 17p-value: 0.888995% CI: [-39.58, 34.58]ANCOVA
Comparison: Week 18p-value: 0.709995% CI: [-42.67, 29.7]ANCOVA
Comparison: Week 19p-value: 0.72795% CI: [-42.4, 30.19]ANCOVA
Comparison: Week 20p-value: 0.836695% CI: [-40.47, 33.16]ANCOVA
Comparison: Week 21p-value: 0.801395% CI: [-42.99, 33.69]ANCOVA
Comparison: Week 22p-value: 0.68195% CI: [-43.56, 29.15]ANCOVA
Comparison: Week 23p-value: 0.834795% CI: [-41.08, 33.58]ANCOVA
Comparison: Week 24p-value: 0.935895% CI: [-38.18, 35.33]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 7 | -45.3 percentage change | Standard Error 7.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 2 | -21.9 percentage change | Standard Error 5.59 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 3 | -29.6 percentage change | Standard Error 5.94 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 4 | -33.6 percentage change | Standard Error 7.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 5 | -39.6 percentage change | Standard Error 7.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 6 | -42.8 percentage change | Standard Error 7.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 1 | -11.0 percentage change | Standard Error 5.98 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 8 | -46.1 percentage change | Standard Error 7.52 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 9 | -42.0 percentage change | Standard Error 7.52 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 22 | -39.7 percentage change | Standard Error 12.7 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 10 | -42.8 percentage change | Standard Error 7.38 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 11 | -41.5 percentage change | Standard Error 7.49 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 12 | -40.1 percentage change | Standard Error 7.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 13 | -40.9 percentage change | Standard Error 7.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 14 | -40.3 percentage change | Standard Error 8.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 15 | -44.0 percentage change | Standard Error 7.94 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 16 | -45.7 percentage change | Standard Error 7.71 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 17 | -33.2 percentage change | Standard Error 12.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 18 | -38.8 percentage change | Standard Error 12.59 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 19 | -41.4 percentage change | Standard Error 12.76 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 20 | -37.3 percentage change | Standard Error 12.79 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 21 | -42.3 percentage change | Standard Error 13.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 23 | -41.2 percentage change | Standard Error 13.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 24 | -42.4 percentage change | Standard Error 13 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 12 | -36.1 percentage change | Standard Error 7.11 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 1 | -12.0 percentage change | Standard Error 5.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 22 | -35.9 percentage change | Standard Error 11.68 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 2 | -20.6 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 13 | -37.5 percentage change | Standard Error 7.4 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 3 | -20.9 percentage change | Standard Error 5.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 19 | -36.3 percentage change | Standard Error 11.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 4 | -26.1 percentage change | Standard Error 6.8 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 14 | -36.9 percentage change | Standard Error 8.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 5 | -28.8 percentage change | Standard Error 6.99 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 24 | -35.0 percentage change | Standard Error 11.96 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 6 | -30.9 percentage change | Standard Error 6.99 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 15 | -37.0 percentage change | Standard Error 7.67 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 7 | -31.1 percentage change | Standard Error 7.14 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 20 | -37.6 percentage change | Standard Error 11.77 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 8 | -33.5 percentage change | Standard Error 7.27 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 16 | -38.8 percentage change | Standard Error 7.45 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 9 | -37.0 percentage change | Standard Error 7.26 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 23 | -34.8 percentage change | Standard Error 12.34 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 17 | -35.8 percentage change | Standard Error 11.94 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 10 | -36.0 percentage change | Standard Error 7.12 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 21 | -36.5 percentage change | Standard Error 12.33 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 11 | -39.2 percentage change | Standard Error 7.23 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Week 18 | -37.1 percentage change | Standard Error 11.59 |
Comparison: Week 1p-value: 0.894895% CI: [-15.2, 17.35]ANCOVA
Comparison: Week 2p-value: 0.858195% CI: [-16.58, 13.86]ANCOVA
Comparison: Week 3p-value: 0.279795% CI: [-24.93, 7.38]ANCOVA
Comparison: Week 4p-value: 0.433395% CI: [-26.67, 11.64]ANCOVA
Comparison: Week 5p-value: 0.277495% CI: [-30.44, 8.95]ANCOVA
Comparison: Week 6p-value: 0.230895% CI: [-31.55, 7.82]ANCOVA
Comparison: Week 7p-value: 0.161795% CI: [-34.34, 5.91]ANCOVA
Comparison: Week 8p-value: 0.22295% CI: [-33.05, 7.89]ANCOVA
Comparison: Week 9p-value: 0.619595% CI: [-25.54, 15.38]ANCOVA
Comparison: Week 10p-value: 0.498495% CI: [-26.86, 13.27]ANCOVA
Comparison: Week 11p-value: 0.814795% CI: [-22.75, 17.99]ANCOVA
Comparison: Week 12p-value: 0.691795% CI: [-24.01, 16.07]ANCOVA
Comparison: Week 13p-value: 0.743795% CI: [-24.24, 17.43]ANCOVA
Comparison: Week 14p-value: 0.766395% CI: [-26.26, 19.47]ANCOVA
Comparison: Week 15p-value: 0.515795% CI: [-28.61, 14.75]ANCOVA
Comparison: Week 16p-value: 0.511595% CI: [-27.86, 14.09]ANCOVA
Comparison: Week 17p-value: 0.879595% CI: [-33.68, 39]ANCOVA
Comparison: Week 18p-value: 0.925495% CI: [-37.73, 34.48]ANCOVA
Comparison: Week 19p-value: 0.771895% CI: [-41.68, 31.47]ANCOVA
Comparison: Week 20p-value: 0.985595% CI: [-36.34, 36.98]ANCOVA
Comparison: Week 21p-value: 0.750895% CI: [-44.29, 32.54]ANCOVA
Comparison: Week 22p-value: 0.82695% CI: [-40.26, 32.55]ANCOVA
Comparison: Week 23p-value: 0.725995% CI: [-44.95, 31.96]ANCOVA
Comparison: Week 24p-value: 0.682695% CI: [-44.61, 29.92]ANCOVA
Secondary
Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -50.5 percentage change | Standard Error 7.01 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -27.3 percentage change | Standard Error 5 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -33.6 percentage change | Standard Error 5.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -42.3 percentage change | Standard Error 6.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -46.6 percentage change | Standard Error 6.48 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -48.3 percentage change | Standard Error 6.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -20.2 percentage change | Standard Error 4.21 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -50.6 percentage change | Standard Error 6.99 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -47.0 percentage change | Standard Error 6.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -47.9 percentage change | Standard Error 6.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -44.8 percentage change | Standard Error 6.84 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -43.9 percentage change | Standard Error 6.59 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -46.3 percentage change | Standard Error 6.59 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -48.9 percentage change | Standard Error 6.97 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -48.8 percentage change | Standard Error 6.93 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -50.4 percentage change | Standard Error 6.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -47.0 percentage change | Standard Error 10.96 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -50.9 percentage change | Standard Error 10.83 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -51.2 percentage change | Standard Error 10.51 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -50.1 percentage change | Standard Error 10.76 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -50.2 percentage change | Standard Error 11.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -50.3 percentage change | Standard Error 10.52 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -51.7 percentage change | Standard Error 11.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -51.8 percentage change | Standard Error 11.76 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -37.5 percentage change | Standard Error 10.21 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -9.1 percentage change | Standard Error 4.09 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -28.1 percentage change | Standard Error 6.41 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -13.9 percentage change | Standard Error 4.86 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -39.6 percentage change | Standard Error 9.55 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -18.1 percentage change | Standard Error 5.24 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -27.6 percentage change | Standard Error 6.78 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -22.8 percentage change | Standard Error 6.1 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -38.0 percentage change | Standard Error 9.55 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -28.0 percentage change | Standard Error 6.29 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -29.6 percentage change | Standard Error 6.74 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -27.9 percentage change | Standard Error 6.1 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -43.9 percentage change | Standard Error 9.77 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -29.7 percentage change | Standard Error 6.81 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -31.3 percentage change | Standard Error 6.25 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -29.4 percentage change | Standard Error 6.8 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -33.8 percentage change | Standard Error 10.68 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -29.7 percentage change | Standard Error 6.5 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -36.5 percentage change | Standard Error 10.4 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -30.8 percentage change | Standard Error 6.24 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -41.0 percentage change | Standard Error 10.07 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -34.0 percentage change | Standard Error 6.65 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -38.1 percentage change | Standard Error 9.84 |
| Phase 2a - Placebo SC QW | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -29.9 percentage change | Standard Error 6.41 |
Comparison: Week 1p-value: 0.065795% CI: [-22.85, 0.75]ANCOVA
Comparison: Week 2p-value: 0.059595% CI: [-27.48, 0.56]ANCOVA
Comparison: Week 3p-value: 0.045595% CI: [-30.55, -0.33]ANCOVA
Comparison: Week 4p-value: 0.030595% CI: [-37.11, -1.93]ANCOVA
Comparison: Week 5p-value: 0.045695% CI: [-36.69, -0.38]ANCOVA
Comparison: Week 6p-value: 0.023695% CI: [-38.06, -2.88]ANCOVA
Comparison: Week 7p-value: 0.038595% CI: [-40.45, -1.15]ANCOVA
Comparison: Week 8p-value: 0.034795% CI: [-40.82, -1.6]ANCOVA
Comparison: Week 9p-value: 0.069495% CI: [-36.06, 1.44]ANCOVA
Comparison: Week 10p-value: 0.062195% CI: [-35.08, 0.9]ANCOVA
Comparison: Week 11p-value: 0.261995% CI: [-30, 8.37]ANCOVA
Comparison: Week 12p-value: 0.134495% CI: [-32.48, 4.5]ANCOVA
Comparison: Week 13p-value: 0.053395% CI: [-36.71, 0.27]ANCOVA
Comparison: Week 14p-value: 0.033595% CI: [-40.82, -1.74]ANCOVA
Comparison: Week 15p-value: 0.053695% CI: [-38.58, 0.31]ANCOVA
Comparison: Week 16p-value: 0.038895% CI: [-37.11, -1.03]ANCOVA
Comparison: Week 17p-value: 0.518195% CI: [-43.94, 22.95]ANCOVA
Comparison: Week 18p-value: 0.414295% CI: [-45.08, 19.47]ANCOVA
Comparison: Week 19p-value: 0.44595% CI: [-42.94, 19.72]ANCOVA
Comparison: Week 20p-value: 0.689795% CI: [-38.23, 25.89]ANCOVA
Comparison: Week 21p-value: 0.563695% CI: [-42.25, 23.81]ANCOVA
Comparison: Week 22p-value: 0.41995% CI: [-43.64, 19.04]ANCOVA
Comparison: Week 23p-value: 0.381895% CI: [-47.76, 19.24]ANCOVA
Comparison: Week 24p-value: 0.295795% CI: [-52.97, 17.13]ANCOVA
Secondary
Phase 2b: Change From Baseline in ItchyQoL Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; WOCF: Baseline through Week 52.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 32 | -33.9 score on a scale | Standard Error 3.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 20 | -31.0 score on a scale | Standard Error 2.85 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 52 | -34.7 score on a scale | Standard Error 3.22 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 16 | -28.8 score on a scale | Standard Error 2.78 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 12 | -27.0 score on a scale | Standard Error 2.93 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 8 | -26.1 score on a scale | Standard Error 2.57 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 48 | -34.8 score on a scale | Standard Error 3.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 18 | -30.6 score on a scale | Standard Error 2.93 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 4 | -19.7 score on a scale | Standard Error 2.19 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 18 | -27.7 score on a scale | Standard Error 2.98 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 32 | -29.4 score on a scale | Standard Error 3.21 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 20 | -28.3 score on a scale | Standard Error 2.96 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 8 | -17.4 score on a scale | Standard Error 2.52 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 4 | -13.4 score on a scale | Standard Error 2.23 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 12 | -22.7 score on a scale | Standard Error 2.96 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 52 | -34.0 score on a scale | Standard Error 3.32 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 48 | -30.6 score on a scale | Standard Error 3.27 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 16 | -23.4 score on a scale | Standard Error 2.83 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 18 | -22.5 score on a scale | Standard Error 3.07 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 4 | -11.5 score on a scale | Standard Error 2.26 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 8 | -12.1 score on a scale | Standard Error 2.54 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 12 | -15.4 score on a scale | Standard Error 3.09 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 16 | -18.2 score on a scale | Standard Error 2.87 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 20 | -25.1 score on a scale | Standard Error 2.99 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 32 | -27.8 score on a scale | Standard Error 3.22 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 48 | -27.9 score on a scale | Standard Error 3.15 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 52 | -31.1 score on a scale | Standard Error 3.3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 32 | -26.0 score on a scale | Standard Error 3.11 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 16 | -7.8 score on a scale | Standard Error 2.87 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 12 | -6.4 score on a scale | Standard Error 3.07 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 52 | -29.8 score on a scale | Standard Error 3.27 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 48 | -30.4 score on a scale | Standard Error 3.2 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 8 | -5.1 score on a scale | Standard Error 2.54 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 20 | -23.7 score on a scale | Standard Error 3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 18 | -17.9 score on a scale | Standard Error 3.22 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in ItchyQoL Over Time | Week 4 | -1.7 score on a scale | Standard Error 2.15 |
Comparison: Week 4p-value: <0.000195% CI: [-24.1, -12]ANCOVA
Comparison: Week 4p-value: 0.000295% CI: [-17.8, -5.6]ANCOVA
Comparison: Week 4p-value: 0.001795% CI: [-15.9, -3.8]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-28, -13.9]ANCOVA
Comparison: Week 8p-value: 0.000695% CI: [-19.3, -5.4]ANCOVA
Comparison: Week 8p-value: 0.049795% CI: [-13.9, 0]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-28.9, -12.3]ANCOVA
Comparison: Week 12p-value: 0.000295% CI: [-24.6, -8]ANCOVA
Comparison: Week 12p-value: 0.036295% CI: [-17.5, -0.6]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-28.8, -13.2]ANCOVA
Comparison: Week 16p-value: 0.000195% CI: [-23.5, -7.7]ANCOVA
Comparison: Week 16p-value: 0.0195% CI: [-18.3, -2.5]ANCOVA
Comparison: Week 18p-value: 0.003595% CI: [-21.1, -4.3]ANCOVA
Comparison: Week 18p-value: 0.025595% CI: [-18.3, -1.2]ANCOVA
Comparison: Week 18p-value: 0.286995% CI: [-13.1, 3.9]ANCOVA
Comparison: Week 20p-value: 0.07695% CI: [-15.4, 0.8]ANCOVA
Comparison: Week 20p-value: 0.267395% CI: [-12.8, 3.6]ANCOVA
Comparison: Week 20p-value: 0.73295% CI: [-9.6, 6.8]ANCOVA
Comparison: Week 32p-value: 0.072695% CI: [-16.4, 0.7]ANCOVA
Comparison: Week 32p-value: 0.447595% CI: [-12.1, 5.4]ANCOVA
Comparison: Week 32p-value: 0.685495% CI: [-10.5, 6.9]ANCOVA
Comparison: Week 48p-value: 0.328795% CI: [-13.3, 4.5]ANCOVA
Comparison: Week 48p-value: 0.975295% CI: [-9, 8.7]ANCOVA
Comparison: Week 48p-value: 0.576195% CI: [-6.2, 11.2]ANCOVA
Comparison: Week 52p-value: 0.281795% CI: [-13.9, 4.1]ANCOVA
Comparison: Week 52p-value: 0.355495% CI: [-13.3, 4.8]ANCOVA
Comparison: Week 52p-value: 0.771395% CI: [-10.4, 7.7]ANCOVA
Secondary
Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time
Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). A score was set to missing after a participant received prohibited/rescue medication that potentially impact efficacy analyses prior to Week 16, and the participant's worst post baseline observation before the time of the medication usage was carried forward (WOCF) to impute missing endpoint value (for participants whose postbaseline values were all missing, the baseline was used to impute). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; WOCF: Baseline through Week 52.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -2.9 units on a scale | Standard Deviation 0.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -3.1 units on a scale | Standard Deviation 0.34 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -3.2 units on a scale | Standard Deviation 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -3.6 units on a scale | Standard Deviation 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -3.5 units on a scale | Standard Deviation 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -3.8 units on a scale | Standard Deviation 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -3.9 units on a scale | Standard Deviation 0.38 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -4.1 units on a scale | Standard Deviation 0.38 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -4.5 units on a scale | Standard Deviation 0.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -4.5 units on a scale | Standard Deviation 0.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -3.0 units on a scale | Standard Deviation 0.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -4.4 units on a scale | Standard Deviation 0.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -3.2 units on a scale | Standard Deviation 0.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -3.3 units on a scale | Standard Deviation 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -3.6 units on a scale | Standard Deviation 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -3.8 units on a scale | Standard Deviation 0.39 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -4.4 units on a scale | Standard Deviation 0.42 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -4.1 units on a scale | Standard Deviation 0.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -2.4 units on a scale | Standard Deviation 0.39 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -2.1 units on a scale | Standard Deviation 0.35 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -3.3 units on a scale | Standard Deviation 0.4 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -2.7 units on a scale | Standard Deviation 0.39 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -3.8 units on a scale | Standard Deviation 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -1.5 units on a scale | Standard Deviation 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -1.8 units on a scale | Standard Deviation 0.45 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -2.4 units on a scale | Standard Deviation 0.45 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -3.7 units on a scale | Standard Deviation 0.38 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -1.3 units on a scale | Standard Deviation 0.36 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -2.1 units on a scale | Standard Deviation 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -1.9 units on a scale | Standard Deviation 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -1.5 units on a scale | Standard Deviation 0.44 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -3.5 units on a scale | Standard Deviation 0.39 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -2.3 units on a scale | Standard Deviation 0.47 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -3.9 units on a scale | Standard Deviation 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -3.0 units on a scale | Standard Deviation 0.39 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -0.1 units on a scale | Standard Deviation 0.33 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -1.0 units on a scale | Standard Deviation 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -1.1 units on a scale | Standard Deviation 0.45 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -0.1 units on a scale | Standard Deviation 0.38 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -3.7 units on a scale | Standard Deviation 0.39 |
Comparison: Week 2p-value: <0.000195% CI: [-3.8, -1.6]ANCOVA
Comparison: Week 2p-value: <0.000195% CI: [-3.3, -1.2]ANCOVA
Comparison: Week 2p-value: 0.012595% CI: [-2.5, -0.3]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-3.8, -2]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-2.9, -1]ANCOVA
Comparison: Week 4p-value: 0.019895% CI: [-2.1, -0.2]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-3.4, -1.2]ANCOVA
Comparison: Week 8p-value: 0.000495% CI: [-3.2, -0.9]ANCOVA
Comparison: Week 8p-value: 0.096995% CI: [-2.1, 0.2]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-3.7, -1.3]ANCOVA
Comparison: Week 12p-value: 0.001295% CI: [-3.2, -0.8]ANCOVA
Comparison: Week 12p-value: 0.321295% CI: [-1.9, 0.6]ANCOVA
Comparison: Week 16p-value: 0.001195% CI: [-3.2, -0.8]ANCOVA
Comparison: Week 16p-value: 0.004495% CI: [-3, -0.6]ANCOVA
Comparison: Week 16p-value: 0.363595% CI: [-1.8, 0.7]ANCOVA
Comparison: Week 18p-value: 0.017295% CI: [-2.7, -0.3]ANCOVA
Comparison: Week 18p-value: 0.040195% CI: [-2.6, -0.1]ANCOVA
Comparison: Week 18p-value: 0.762795% CI: [-1.4, 1.1]ANCOVA
Comparison: Week 20p-value: 0.082795% CI: [-2, 0.1]ANCOVA
Comparison: Week 20p-value: 0.131595% CI: [-1.9, 0.3]ANCOVA
Comparison: Week 20p-value: 0.613395% CI: [-0.8, 1.4]ANCOVA
Comparison: Week 32p-value: 0.313695% CI: [-1.6, 0.5]ANCOVA
Comparison: Week 32p-value: 0.321895% CI: [-1.6, 0.5]ANCOVA
Comparison: Week 32p-value: 0.657695% CI: [-0.8, 1.3]ANCOVA
Comparison: Week 48p-value: 0.156595% CI: [-1.9, 0.3]ANCOVA
Comparison: Week 48p-value: 0.22895% CI: [-1.7, 0.4]ANCOVA
Comparison: Week 48p-value: 0.9495% CI: [-1, 1.1]ANCOVA
Comparison: Week 52p-value: 0.27695% CI: [-1.8, 0.5]ANCOVA
Comparison: Week 52p-value: 0.409695% CI: [-1.6, 0.7]ANCOVA
Comparison: Week 52p-value: 0.817795% CI: [-1, 1.3]ANCOVA
Secondary
Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1 through 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -6.4 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -5.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -4.4 units on a scale | Standard Error 0.37 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -6.4 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -5.8 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -5.9 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -3.4 units on a scale | Standard Error 0.32 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -6.4 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -6.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -6.7 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -6.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -4.6 units on a scale | Standard Error 0.38 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -6.4 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -6.0 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -1.7 units on a scale | Standard Error 0.21 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -6.2 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -6.2 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -6.2 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -4.7 units on a scale | Standard Error 0.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -6.7 units on a scale | Standard Error 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -4.8 units on a scale | Standard Error 0.4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -4.8 units on a scale | Standard Error 0.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -3.8 units on a scale | Standard Error 0.33 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -6.7 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -4.9 units on a scale | Standard Error 0.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -4.9 units on a scale | Standard Error 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -2.8 units on a scale | Standard Error 0.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -6.5 units on a scale | Standard Error 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -5.0 units on a scale | Standard Error 0.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -6.6 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -4.9 units on a scale | Standard Error 0.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -4.0 units on a scale | Standard Error 0.33 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -6.6 units on a scale | Standard Error 0.41 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -5.2 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -5.3 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -6.5 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -5.4 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -5.4 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -4.2 units on a scale | Standard Error 0.35 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -6.3 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -5.5 units on a scale | Standard Error 0.44 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -5.5 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -6.5 units on a scale | Standard Error 0.42 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -5.5 units on a scale | Standard Error 0.46 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -6.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -5.5 units on a scale | Standard Error 0.46 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -4.3 units on a scale | Standard Error 0.36 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -6.4 units on a scale | Standard Error 0.43 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -5.6 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -5.6 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -6.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -5.5 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -5.0 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -5.6 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -6.3 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -6.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -4.5 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -5.6 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -5.7 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -6.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -5.6 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -5.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -3.6 units on a scale | Standard Error 0.36 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -5.9 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -4.4 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -5.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -5.3 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -6.3 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -3.2 units on a scale | Standard Error 0.34 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -5.9 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -4.3 units on a scale | Standard Error 0.42 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -5.9 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -6.1 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -5.8 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -5.5 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -5.3 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -4.9 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -5.8 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -2.9 units on a scale | Standard Error 0.33 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -5.8 units on a scale | Standard Error 0.45 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -6.0 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -5.9 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -3.9 units on a scale | Standard Error 0.37 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -1.1 units on a scale | Standard Error 0.21 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -4.9 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -5.7 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -2.2 units on a scale | Standard Error 0.32 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -6.4 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -1.9 units on a scale | Standard Error 0.29 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -4.2 units on a scale | Standard Error 0.39 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -6.2 units on a scale | Standard Error 0.49 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -3.5 units on a scale | Standard Error 0.35 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -6.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -4.2 units on a scale | Standard Error 0.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -6.5 units on a scale | Standard Error 0.48 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -6.2 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -5.1 units on a scale | Standard Error 0.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -3.9 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -6.2 units on a scale | Standard Error 0.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -6.2 units on a scale | Standard Error 0.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -5.3 units on a scale | Standard Error 0.47 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -4.4 units on a scale | Standard Error 0.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -2.5 units on a scale | Standard Error 0.33 |
| Phase 2a - Placebo SC QW | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -6.3 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -5.2 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -0.9 units on a scale | Standard Error 0.21 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -1.9 units on a scale | Standard Error 0.3 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -1.8 units on a scale | Standard Error 0.32 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -1.5 units on a scale | Standard Error 0.33 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -2.0 units on a scale | Standard Error 0.33 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -2.4 units on a scale | Standard Error 0.34 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -2.3 units on a scale | Standard Error 0.36 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -2.3 units on a scale | Standard Error 0.37 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -2.7 units on a scale | Standard Error 0.38 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -3.1 units on a scale | Standard Error 0.39 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -2.8 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -2.5 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -3.1 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -3.2 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -3.1 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -2.9 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -3.7 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -3.9 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -4.4 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -4.4 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -4.7 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -4.6 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -4.8 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -4.8 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -4.9 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -4.9 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -5.2 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -5.1 units on a scale | Standard Error 0.45 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -5.2 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -5.2 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -5.3 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -5.2 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -5.3 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -5.4 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -5.4 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -5.5 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -5.5 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -5.7 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -5.7 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -5.9 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -5.8 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -5.9 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -5.9 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -5.6 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -5.6 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -5.7 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -5.8 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -5.6 units on a scale | Standard Error 0.46 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -5.9 units on a scale | Standard Error 0.46 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -6.0 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -5.6 units on a scale | Standard Error 0.45 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -4.5 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -4.6 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -5.8 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -5.1 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -4.4 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -4.4 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -0.9 units on a scale | Standard Error 0.33 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -5.4 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -4.1 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -3.9 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -0.8 units on a scale | Standard Error 0.33 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -5.4 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -3.5 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -3.3 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -0.4 units on a scale | Standard Error 0.21 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -5.4 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -2.7 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -2.1 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -5.7 units on a scale | Standard Error 0.44 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -5.5 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -1.2 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -1.2 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -0.8 units on a scale | Standard Error 0.33 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -5.4 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -1.3 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -1.5 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -0.7 units on a scale | Standard Error 0.31 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -5.5 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -1.3 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -1.2 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -5.7 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -5.6 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -1.2 units on a scale | Standard Error 0.39 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -1.1 units on a scale | Standard Error 0.37 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -5.5 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -4.9 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -4.8 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -4.8 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -5.6 units on a scale | Standard Error 0.4 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -4.9 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -4.7 units on a scale | Standard Error 0.41 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -4.8 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -1.0 units on a scale | Standard Error 0.36 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -5.0 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -4.5 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -4.7 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -0.9 units on a scale | Standard Error 0.35 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -5.1 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -4.5 units on a scale | Standard Error 0.43 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -4.5 units on a scale | Standard Error 0.42 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -0.7 units on a scale | Standard Error 0.29 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -5.1 units on a scale | Standard Error 0.41 |
Comparison: Week 1p-value: <0.000195% CI: [-1.8, -0.7]ANCOVA
Comparison: Week 1p-value: 0.028795% CI: [-1.2, -0.1]ANCOVA
Comparison: Week 1p-value: 0.112395% CI: [-1, 0.1]ANCOVA
Comparison: Week 2p-value: <0.000195% CI: [-3, -1.3]ANCOVA
Comparison: Week 2p-value: 0.004495% CI: [-2, -0.4]ANCOVA
Comparison: Week 2p-value: 0.004695% CI: [-2, -0.4]ANCOVA
Comparison: Week 3p-value: <0.000195% CI: [-3.6, -1.8]ANCOVA
Comparison: Week 3p-value: 0.001195% CI: [-2.3, -0.6]ANCOVA
Comparison: Week 3p-value: 0.017195% CI: [-1.9, -0.2]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-4, -2.1]ANCOVA
Comparison: Week 4p-value: 0.000295% CI: [-2.6, -0.8]ANCOVA
Comparison: Week 4p-value: 0.114695% CI: [-1.6, 0.2]ANCOVA
Comparison: Week 5p-value: <0.000195% CI: [-4.2, -2.3]ANCOVA
Comparison: Week 5p-value: <0.000195% CI: [-3, -1.2]ANCOVA
Comparison: Week 5p-value: 0.008795% CI: [-2.1, -0.3]ANCOVA
Comparison: Week 6p-value: <0.000195% CI: [-4.3, -2.4]ANCOVA
Comparison: Week 6p-value: <0.000195% CI: [-3.3, -1.4]ANCOVA
Comparison: Week 6p-value: 0.001395% CI: [-2.5, -0.6]ANCOVA
Comparison: Week 7p-value: <0.000195% CI: [-4.4, -2.4]ANCOVA
Comparison: Week 7p-value: <0.000195% CI: [-3.6, -1.6]ANCOVA
Comparison: Week 7p-value: 0.004895% CI: [-2.4, -0.4]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-4.5, -2.4]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-3.6, -1.6]ANCOVA
Comparison: Week 8p-value: 0.012495% CI: [-2.3, -0.3]ANCOVA
Comparison: Week 9p-value: <0.000195% CI: [-4.5, -2.5]ANCOVA
Comparison: Week 9p-value: <0.000195% CI: [-3.8, -1.7]ANCOVA
Comparison: Week 9p-value: 0.002195% CI: [-2.7, -0.6]ANCOVA
Comparison: Week 10p-value: <0.000195% CI: [-4.6, -2.4]ANCOVA
Comparison: Week 10p-value: <0.000195% CI: [-4, -1.9]ANCOVA
Comparison: Week 10p-value: 0.000595% CI: [-3, -0.9]ANCOVA
Comparison: Week 11p-value: <0.000195% CI: [-4.6, -2.4]ANCOVA
Comparison: Week 11p-value: <0.000195% CI: [-4.1, -1.8]ANCOVA
Comparison: Week 11p-value: 0.004495% CI: [-2.7, -0.5]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-4.7, -2.4]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-3.8, -1.6]ANCOVA
Comparison: Week 12p-value: 0.023195% CI: [-2.4, -0.2]ANCOVA
Comparison: Week 13p-value: <0.000195% CI: [-4.5, -2.2]ANCOVA
Comparison: Week 13p-value: <0.000195% CI: [-4, -1.7]ANCOVA
Comparison: Week 13p-value: 0.007495% CI: [-2.7, -0.4]ANCOVA
Comparison: Week 14p-value: <0.000195% CI: [-4.8, -2.5]ANCOVA
Comparison: Week 14p-value: <0.000195% CI: [-4.3, -2.1]ANCOVA
Comparison: Week 14p-value: 0.001395% CI: [-3, -0.7]ANCOVA
Comparison: Week 15p-value: <0.000195% CI: [-4.8, -2.6]ANCOVA
Comparison: Week 15p-value: <0.000195% CI: [-4.3, -2.1]ANCOVA
Comparison: Week 15p-value: 0.00195% CI: [-3, -0.8]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-4.8, -2.5]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-4.2, -2]ANCOVA
Comparison: Week 16p-value: 0.00495% CI: [-2.8, -0.5]ANCOVA
Comparison: Week 17p-value: <0.000195% CI: [-4.2, -1.9]ANCOVA
Comparison: Week 17p-value: <0.000195% CI: [-3.9, -1.6]ANCOVA
Comparison: Week 17p-value: 0.008795% CI: [-2.7, -0.4]ANCOVA
Comparison: Week 18p-value: <0.000195% CI: [-3.8, -1.4]ANCOVA
Comparison: Week 18p-value: 0.000395% CI: [-3.4, -1]ANCOVA
Comparison: Week 18p-value: 0.35995% CI: [-2.4, -0.1]ANCOVA
Comparison: Week 19p-value: 0.000595% CI: [-3.3, -0.9]ANCOVA
Comparison: Week 19p-value: 0.002795% CI: [-3.1, -0.6]ANCOVA
Comparison: Week 19p-value: 0.065795% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 20p-value: 0.002195% CI: [-3.1, -0.7]ANCOVA
Comparison: Week 20p-value: 0.017295% CI: [-2.7, -0.3]ANCOVA
Comparison: Week 20p-value: 0.134495% CI: [-2.1, -0.3]ANCOVA
Comparison: Week 21p-value: 0.013495% CI: [-2.7, -0.3]ANCOVA
Comparison: Week 21p-value: 0.02695% CI: [-2.6, -0.2]ANCOVA
Comparison: Week 21p-value: 0.21595% CI: [-1.9, 0.4]ANCOVA
Comparison: Week 22p-value: 0.027195% CI: [-2.6, -0.2]ANCOVA
Comparison: Week 22p-value: 0.050295% CI: [-2.5, 0]ANCOVA
Comparison: Week 22p-value: 0.413895% CI: [-1.7, 0.7]ANCOVA
Comparison: Week 23p-value: 0.073895% CI: [-2.4, 0.1]ANCOVA
Comparison: Week 23p-value: 0.124795% CI: [-2.2, 0.3]ANCOVA
Comparison: Week 23p-value: 0.457295% CI: [-1.7, 0.8]ANCOVA
Comparison: Week 24p-value: 0.061795% CI: [-2.4, 0.1]ANCOVA
Comparison: Week 24p-value: 0.67795% CI: [-2.4, 0.1]ANCOVA
Comparison: Week 24p-value: 0.468895% CI: [-1.7, 0.8]ANCOVA
Comparison: Week 25p-value: 0.109395% CI: [-2.2, 0.2]ANCOVA
Comparison: Week 25p-value: 0.119695% CI: [-2.2, 0.3]ANCOVA
Comparison: Week 25p-value: 0.576395% CI: [-1.5, 0.9]ANCOVA
Comparison: Week 26p-value: 0.066195% CI: [-2.4, 0.1]ANCOVA
Comparison: Week 26p-value: 0.062295% CI: [-2.4, 0.1]ANCOVA
Comparison: Week 26p-value: 0.467795% CI: [-1.6, 0.8]ANCOVA
Comparison: Week 27p-value: 0.085495% CI: [-2.2, 0.1]ANCOVA
Comparison: Week 27p-value: 0.076895% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 27p-value: 0.25695% CI: [-1.9, 0.5]ANCOVA
Comparison: Week 28p-value: 0.033795% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 28p-value: 0.077895% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 28p-value: 0.321895% CI: [-1.8, 0.6]ANCOVA
Comparison: Week 29p-value: 0.054995% CI: [-2.3, 0]ANCOVA
Comparison: Week 29p-value: 0.054395% CI: [-2.4, 0]ANCOVA
Comparison: Week 29p-value: 0.375995% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 30p-value: 0.028695% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 30p-value: 0.047795% CI: [-2.4, 0]ANCOVA
Comparison: Week 30p-value: 0.269995% CI: [-1.8, 0.5]ANCOVA
Comparison: Week 31p-value: 0.029495% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 31p-value: 0.070295% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 31p-value: 0.363695% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 32p-value: 0.027395% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 32p-value: 0.078595% CI: [-2.2, 0.1]ANCOVA
Comparison: Week 32p-value: 0.411195% CI: [-1.6, 0.7]ANCOVA
Comparison: Week 33p-value: 0.047195% CI: [-2.4, 0]ANCOVA
Comparison: Week 33p-value: 0.089195% CI: [-2.2, 0.2]ANCOVA
Comparison: Week 33p-value: 0.48295% CI: [-1.6, 0.7]ANCOVA
Comparison: Week 34p-value: 0.022295% CI: [-2.6, -0.2]ANCOVA
Comparison: Week 34p-value: 0.068295% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 34p-value: 0.411295% CI: [-1.7, 0.7]ANCOVA
Comparison: Week 35p-value: 0.030795% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 35p-value: 0.153895% CI: [-2, 0.3]ANCOVA
Comparison: Week 35p-value: 0.404795% CI: [-1.7, 0.7]ANCOVA
Comparison: Week 36p-value: 0.02695% CI: [-2.5, -0.2]ANCOVA
Comparison: Week 36p-value: 0.122395% CI: [-2.1, 0.3]ANCOVA
Comparison: Week 36p-value: 0.364195% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 37p-value: 0.028495% CI: [-2.6, -0.1]ANCOVA
Comparison: Week 37p-value: 0.153495% CI: [-2.1, 0.3]ANCOVA
Comparison: Week 37p-value: 0.391495% CI: [-1.7, 0.7]ANCOVA
Comparison: Week 38p-value: 0.026595% CI: [-2.6, -0.2]ANCOVA
Comparison: Week 38p-value: 0.168295% CI: [-2, 0.4]ANCOVA
Comparison: Week 38p-value: 0.469995% CI: [-1.6, 0.7]ANCOVA
Comparison: Week 39p-value: 0.024195% CI: [-2.5, -0.2]ANCOVA
Comparison: Week 39p-value: 0.106495% CI: [-2.1, 0.2]ANCOVA
Comparison: Week 39p-value: 0.294895% CI: [-1.7, 0.5]ANCOVA
Comparison: Week 40p-value: 0.028295% CI: [-2.5, -0.1]ANCOVA
Comparison: Week 40p-value: 0.107495% CI: [-2.1, 0.2]ANCOVA
Comparison: Week 40p-value: 0.306195% CI: [-1.7, 0.5]ANCOVA
Comparison: Week 41p-value: 0.372695% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 41p-value: 0.070595% CI: [-2.2, 0.1]ANCOVA
Comparison: Week 41p-value: 0.240595% CI: [-1.9, 0.5]ANCOVA
Comparison: Week 42p-value: 0.055495% CI: [-2.3, 0]ANCOVA
Comparison: Week 42p-value: 0.238695% CI: [-1.8, 0.5]ANCOVA
Comparison: Week 42p-value: 0.514795% CI: [-1.5, 0.8]ANCOVA
Comparison: Week 43p-value: 0.111695% CI: [-2.1, 0.2]ANCOVA
Comparison: Week 43p-value: 0.126695% CI: [-2, 0.3]ANCOVA
Comparison: Week 43p-value: 0.382295% CI: [-1.6, 0.6]ANCOVA
Comparison: Week 44p-value: 0.07295% CI: [-2.2, 0.1]ANCOVA
Comparison: Week 44p-value: 0.343495% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 44p-value: 0.506195% CI: [-1.5, 0.8]ANCOVA
Comparison: Week 45p-value: 0.036695% CI: [-2.3, -0.1]ANCOVA
Comparison: Week 45p-value: 0.118195% CI: [-2, 0.2]ANCOVA
Comparison: Week 45p-value: 0.707895% CI: [-1.3, 0.9]ANCOVA
Comparison: Week 46p-value: 0.086895% CI: [-2.1, 0.1]ANCOVA
Comparison: Week 46p-value: 0.168395% CI: [-1.9, 0.3]ANCOVA
Comparison: Week 46p-value: 0.890995% CI: [-1.2, 1.1]ANCOVA
Comparison: Week 47p-value: 0.067195% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 47p-value: 0.332595% CI: [-1.7, 0.6]ANCOVA
Comparison: Week 47p-value: 0.891295% CI: [-1.2, 1.1]ANCOVA
Comparison: Week 48p-value: 0.061295% CI: [-2.2, 0.1]ANCOVA
Comparison: Week 48p-value: 0.187995% CI: [-1.9, 0.4]ANCOVA
Comparison: Week 48p-value: 0.769695% CI: [-1.3, 1]ANCOVA
Comparison: Week 49p-value: 0.121195% CI: [-2.1, 0.2]ANCOVA
Comparison: Week 49p-value: 0.390895% CI: [-1.7, 0.7]ANCOVA
Comparison: Week 49p-value: 0.803695% CI: [-1.1, 1.4]ANCOVA
Comparison: Week 50p-value: 0.092895% CI: [-2.3, 0.2]ANCOVA
Comparison: Week 50p-value: 0.443995% CI: [-1.7, 0.8]ANCOVA
Comparison: Week 50p-value: 0.776995% CI: [-1.4, 1.1]ANCOVA
Comparison: Week 51p-value: 0.074295% CI: [-2.3, 0.1]ANCOVA
Comparison: Week 51p-value: 0.149695% CI: [-2.2, 0.3]ANCOVA
Comparison: Week 51p-value: 0.490195% CI: [-1.6, 0.8]ANCOVA
Comparison: Week 52p-value: 0.089595% CI: [-2.3, 0.2]ANCOVA
Comparison: Week 52p-value: 0.457295% CI: [-1.8, 0.8]ANCOVA
Comparison: Week 52p-value: 0.815795% CI: [-1.1, 1.4]ANCOVA
Secondary
Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time
IGA-CNPG-S is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe); 0 (clear) indicates no nodules and 1 (almost clear) indicates rare palpable pruriginous nodules (approximately 1-5 nodules). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Time frame: Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 2 | 4.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 4 | 8.5 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 8 | 14.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 12 | 25.5 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 16 | 34.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 18 | 42.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 20 | 42.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 32 | 44.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 48 | 48.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 52 | 46.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 8 | 10.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 48 | 51.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 12 | 17.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 16 | 25.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 18 | 34.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 20 | 39.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 52 | 48.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 32 | 41.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 4 | 4.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 32 | 21.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 20 | 21.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 52 | 42.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 12 | 10.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 18 | 21.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 48 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 4 | 4.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 16 | 14.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 8 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 16 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 32 | 34.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 18 | 10.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 52 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 20 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 4 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 8 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 12 | 10.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 2 | 0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time | Week 48 | 50.0 percentage of participants |
Comparison: Week 2p-value: 0.1656Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.3026Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.3442Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.164195% CI: [0.47, 45.07]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.510395% CI: [0.2, 25.61]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.545795% CI: [0.19, 22.02]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.072295% CI: [0.8, 22.44]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.221595% CI: [0.51, 16.01]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.487295% CI: [0.03, 5.06]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.05595% CI: [0.95, 9.68]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.351995% CI: [0.52, 6.1]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.826695% CI: [0.22, 3.34]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.000995% CI: [2.11, 30.3]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.011695% CI: [1.32, 18.39]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.212795% CI: [0.59, 10.6]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.000695% CI: [2.17, 22.61]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.006195% CI: [1.47, 14.43]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.231795% CI: [0.62, 6.9]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.009395% CI: [1.36, 9.81]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.018395% CI: [1.21, 8.8]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.764895% CI: [0.4, 3.45]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.33795% CI: [0.65, 3.68]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.505495% CI: [0.57, 3.16]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.134195% CI: [0.19, 1.24]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.962895% CI: [0.43, 2.25]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.918595% CI: [0.46, 2.39]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.049695% CI: [0.18, 1]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.778595% CI: [0.38, 2.04]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.885795% CI: [0.42, 2.13]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.417495% CI: [0.31, 1.62]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time
PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease); 0 (clear) indicates no nodules and 1 (almost clear) indicates nodules are present, few of the nodules are moderately raised.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 32 | 48.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 2 | 6.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 20 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 8 | 23.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 4 | 6.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 12 | 29.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 52 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 48 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 18 | 44.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 16 | 38.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 20 | 46.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 48 | 53.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 52 | 51.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 4 | 4.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 32 | 46.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 8 | 10.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 12 | 25.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 16 | 29.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 2 | 0.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 18 | 34.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 4 | 4.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 20 | 25.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 18 | 19.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 16 | 14.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 52 | 44.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 32 | 34.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 8 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 48 | 36.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 12 | 8.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 52 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 20 | 21.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 2 | 0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 4 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 8 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 12 | 10.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 16 | 10.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 18 | 10.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 32 | 41.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time | Week 48 | 52.2 percentage of participants |
Comparison: Week 2p-value: 0.0841Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.3442Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.308395% CI: [0.31, 33.01]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.490595% CI: [0.21, 22.64]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.637995% CI: [0.15, 21.08]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.007395% CI: [1.48, 36.68]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.245395% CI: [0.49, 14.66]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.485395% CI: [0.04, 4.9]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.020595% CI: [1.15, 10.68]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.054895% CI: [0.95, 9.78]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.685395% CI: [0.19, 2.96]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.001795% CI: [1.83, 17.47]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.019695% CI: [1.19, 10.99]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.621395% CI: [0.4, 4.69]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.000395% CI: [2.33, 23.73]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.00695% CI: [1.5, 15.58]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.343295% CI: [0.54, 6.07]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.001295% CI: [1.84, 13.37]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.012195% CI: [1.27, 8.11]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.831595% CI: [0.41, 3.08]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.416195% CI: [0.61, 3.35]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.627795% CI: [0.54, 2.82]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.412895% CI: [0.29, 1.64]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.972695% CI: [0.42, 2.3]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.90795% CI: [0.46, 2.39]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.094495% CI: [0.21, 1.14]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.651395% CI: [0.37, 1.88]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.592495% CI: [0.35, 1.82]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.231395% CI: [0.27, 1.38]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the presence/absence of nodules and the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease); 0 (clear) indicates no nodules and 1 (almost clear) indicates nodules are present, few of the nodules are moderately raised.
Time frame: Week 16
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 | 38.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 | 14.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 | 10.4 percentage of participants |
p-value: 0.001795% CI: [1.83, 17.47]Cochran-Mantel-Haenszel
p-value: 0.019695% CI: [1.19, 10.99]Cochran-Mantel-Haenszel
p-value: 0.621395% CI: [0.4, 4.69]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Week 16
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 66.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 16.7 percentage of participants |
p-value: <0.000195% CI: [3.34, 22.14]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [2.91, 19.79]Cochran-Mantel-Haenszel
p-value: 0.125295% CI: [0.8, 5.75]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Weeks 1 through 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 66.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 68.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 66.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 64.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 66.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 64.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 66.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 66.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 53.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 66.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 25.5 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 73.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 53.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 10.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 57.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 73.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 57.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 59.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 44.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 66.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 66.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 63.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 71.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 61.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 75.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 68.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 63.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 53.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 68.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 4.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 17.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 17.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 25.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 29.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 38.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 38.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 36.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 51.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 59.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 55.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 57.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 59.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 63.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 59.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 61.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 67.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 76.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 74.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 74.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 76.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 67.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 69.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 74.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 69.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 74.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 69.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 69.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 76.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 72.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 69.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 67.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 65.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 55.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 17.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 36.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 31.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 38.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 4.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 63.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 36.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 72.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 72.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 27.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 72.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 59.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 27.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 17.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 27.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 57.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 21.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 46.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 55.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 48.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 57.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 36.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 68.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 10.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 66.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 38.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 61.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 70.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 71.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 14.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 73.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 60.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 73.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 73.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 60.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 16.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 65.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 65.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 63.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 16.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 71.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 16.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 63.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 73.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 63.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 12.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 71.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 67.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 16.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 63.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 8.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 67.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 67.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 76.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 65.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 8.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 32.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 21.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 69.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 8.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 14.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 43.5 percentage of participants |
Comparison: Week 1p-value: 0.095795% CI: [0.6, 44.6]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.545795% CI: [0.17, 28.14]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.379795% CI: [0.24, 41.51]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.004295% CI: [1.64, 38.75]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.038395% CI: [0.99, 26.09]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.035795% CI: [1.02, 28.92]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: <0.000195% CI: [3.86, 77.91]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.040895% CI: [0.97, 26.01]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.035795% CI: [1.02, 28.92]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.000195% CI: [4.51, 62.54]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.011695% CI: [1.31, 18.78]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.373895% CI: [0.43, 8.82]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: <0.000195% CI: [6.06, 320.77]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.000295% CI: [2.73, 268.93]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.002995% CI: [1.74, 166.84]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: <0.000195% CI: [4.7, 67.78]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.000295% CI: [2.6, 37.44]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.005595% CI: [1.53, 22.53]Cochran-Mantel-Haenszel
Comparison: Week 7p-value: <0.000195% CI: [4.37, 45.75]Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.000595% CI: [2.11, 22.25]Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.01695% CI: [1.25, 14.41]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.000195% CI: [4.37, 45.75]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.000995% CI: [1.93, 20.33]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.015195% CI: [1.25, 14.04]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: <0.000195% CI: [5.35, 69.06]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: <0.000195% CI: [3.48, 38.09]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: 0.001395% CI: [1.86, 20.2]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: <0.000195% CI: [4.89, 43.82]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: <0.000195% CI: [3.44, 26.76]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.004995% CI: [1.48, 11.9]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: <0.000195% CI: [3.17, 21.77]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: <0.000195% CI: [2.2, 13.92]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: 0.093995% CI: [0.85, 5.86]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.000195% CI: [2.91, 20.31]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.000195% CI: [2.51, 16.93]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.142595% CI: [0.77, 5.28]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: <0.000195% CI: [3.61, 27.64]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: <0.000195% CI: [3.08, 22.43]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: 0.019495% CI: [1.17, 8.6]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: <0.000195% CI: [3.5, 23.77]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: <0.000195% CI: [3.11, 20.7]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.026695% CI: [1.12, 7.87]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: <0.000195% CI: [3.85, 28]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: <0.000195% CI: [3.04, 21.86]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: 0.017295% CI: [1.22, 9.29]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [3.34, 22.14]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [2.91, 19.79]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.125295% CI: [0.8, 5.75]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: <0.000195% CI: [3.09, 20.75]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: <0.000195% CI: [3.3, 22.4]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: 0.007495% CI: [1.38, 8.34]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.001595% CI: [1.66, 9.33]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.000395% CI: [2.04, 12.4]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.166795% CI: [0.78, 4.23]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.008795% CI: [1.31, 7.41]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.007995% CI: [1.35, 7.87]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.263195% CI: [0.71, 3.63]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.050495% CI: [0.99, 6.24]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.378195% CI: [0.64, 3.32]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.026395% CI: [1.11, 6.05]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.064395% CI: [0.96, 5.46]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.395495% CI: [0.63, 3.27]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.108395% CI: [0.86, 4.61]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.061395% CI: [0.96, 5.69]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.135495% CI: [0.82, 4.47]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.236295% CI: [0.72, 3.82]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.094995% CI: [0.88, 5.17]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.501395% CI: [0.58, 3.04]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.438695% CI: [0.61, 3.16]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.153595% CI: [0.79, 4.21]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.092595% CI: [0.87, 4.99]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.194895% CI: [0.75, 4.07]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.430495% CI: [0.61, 3.17]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.087395% CI: [0.89, 5.31]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.368395% CI: [0.64, 3.38]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.320395% CI: [0.66, 3.48]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.128495% CI: [0.82, 4.98]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.17995% CI: [0.76, 4.11]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.54795% CI: [0.56, 2.91]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.261295% CI: [0.68, 4.16]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.507195% CI: [0.57, 3.11]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.417595% CI: [0.61, 3.19]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.28495% CI: [0.68, 4.32]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.928195% CI: [0.46, 2.33]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.698795% CI: [0.51, 2.69]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.479495% CI: [0.56, 3.41]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.816495% CI: [0.48, 2.52]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.548495% CI: [0.56, 2.93]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.359695% CI: [0.62, 3.76]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.641495% CI: [0.53, 2.78]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.423395% CI: [0.6, 3.2]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.363295% CI: [0.62, 3.7]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.801895% CI: [0.49, 2.49]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.546595% CI: [0.55, 3.02]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.25695% CI: [0.68, 4.14]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.88195% CI: [0.42, 2.1]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.970195% CI: [0.43, 2.24]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.333195% CI: [0.62, 3.96]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.838695% CI: [0.4, 2.11]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.409195% CI: [0.61, 3.28]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.374695% CI: [0.61, 3.57]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.801895% CI: [0.49, 2.49]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.671795% CI: [0.51, 2.79]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.98595% CI: [0.41, 2.41]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.998395% CI: [0.43, 2.31]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.531195% CI: [0.56, 3.02]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.662895% CI: [0.5, 2.99]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.520895% CI: [0.56, 3.09]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.848395% CI: [0.46, 2.55]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.623295% CI: [0.5, 3.2]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.831295% CI: [0.46, 2.61]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.508395% CI: [0.55, 3.3]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.811195% CI: [0.44, 2.86]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.808995% CI: [0.46, 2.68]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.972395% CI: [0.41, 2.37]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.988395% CI: [0.39, 2.58]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.678195% CI: [0.35, 1.98]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.692495% CI: [0.5, 2.86]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.988395% CI: [0.4, 2.47]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.858195% CI: [0.39, 2.18]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.972395% CI: [0.41, 2.37]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.993795% CI: [0.38, 2.63]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.678195% CI: [0.35, 1.98]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.972395% CI: [0.41, 2.37]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.993795% CI: [0.38, 2.63]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.678195% CI: [0.35, 1.98]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.889295% CI: [0.44, 2.57]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.629695% CI: [0.5, 3.21]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.727195% CI: [0.36, 2.02]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.963695% CI: [0.4, 2.42]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.635595% CI: [0.32, 2]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.390195% CI: [0.28, 1.64]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.517795% CI: [0.54, 3.36]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.99195% CI: [0.4, 2.49]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.706495% CI: [0.35, 2.01]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.837395% CI: [0.44, 2.77]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.761495% CI: [0.44, 3.11]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.530195% CI: [0.31, 1.83]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.824895% CI: [0.44, 2.8]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.837495% CI: [0.35, 2.32]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.408895% CI: [0.29, 1.67]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.974595% CI: [0.39, 2.5]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.491695% CI: [0.28, 1.84]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.185495% CI: [0.23, 1.35]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.837395% CI: [0.44, 2.77]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.505195% CI: [0.29, 1.83]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.137595% CI: [0.21, 1.24]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.71895% CI: [0.49, 2.82]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.783895% CI: [0.37, 2.13]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.579595% CI: [0.34, 1.83]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.551795% CI: [0.54, 3.14]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.60695% CI: [0.34, 1.89]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.749195% CI: [0.38, 2.02]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.859395% CI: [0.45, 2.63]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.186895% CI: [0.23, 1.32]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.243695% CI: [0.26, 1.41]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Week 16
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 42.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 23.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 | 2.1 percentage of participants |
p-value: <0.000195% CI: [5.35, 948.31]Cochran-Mantel-Haenszel
p-value: 0.001995% CI: [1.62, 83.47]Cochran-Mantel-Haenszel
p-value: 0.011795% CI: [1.14, 68.26]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus).
Time frame: Baseline, Weeks 1 through 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 34.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 21.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 31.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 4.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 38.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 40.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 36.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 27.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 36.2 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 42.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 12.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 42.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 42.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 29.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 27.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 46.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 51.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 46.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 46.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 29.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 48.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 48.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 60.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 55.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 37.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 29.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 53.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 19.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 27.7 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 65.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 17.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 23.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 53.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 53.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 34.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 62.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 10.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 21.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 37.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 2.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 4.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 23.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 46.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 21.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 25.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 53.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 41.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 21.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 62.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 51.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 31.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 10.6 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 60.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 2.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 8.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 8.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 6.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 8.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 8.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 10.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 6.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 15.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 19.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 13.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 10.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 19.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 21.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 28.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 39.1 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 34.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 43.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 37.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 43.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 43.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 41.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 60.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 60.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 26 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 25 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 49 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 40 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 24 | 43.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 23 | 43.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 6 | 0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 41 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 22 | 32.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 21 | 32.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 5 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 42 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 20 | 32.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 19 | 23.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 1 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 43 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 18 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 17 | 13.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 50 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 44 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 16 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 15 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 4 | 0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 45 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 14 | 8.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 13 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 3 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 46 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 12 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 11 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 52 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 47 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 10 | 6.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 9 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 51 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 35 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 34 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 33 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 48 | 56.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 36 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 32 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 31 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 8 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 37 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 30 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 29 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 7 | 0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 38 | 50.0 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 28 | 45.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 27 | 47.8 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Week 39 | 52.2 percentage of participants |
Comparison: Week 1p-value: 0.567395% CI: [0.18, 20.86]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.766895% CI: [0.08, 29.41]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.05295% CI: [0.76, 51.82]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.545795% CI: [0.17, 28.14]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.105395% CI: [0.57, 79.79]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.004395% CI: [1.45, 88.33]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 195% CI: [0.06, 18.08]Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.100695% CI: [0.59, 79.12]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.0193Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.0463Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.000295% CI: [2.26, 112.81]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.091795% CI: [0.62, 54.99]Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.100695% CI: [0.59, 79.12]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.0035Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.0269Cochran-Mantel-Haenszel
Comparison: Week 7p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.0009Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.0098Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.000195% CI: [3.21, 258.26]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.007495% CI: [1.31, 79.08]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.246695% CI: [0.37, 26.06]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: 0.000595% CI: [2.37, 56.49]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: 0.01495% CI: [1.25, 29.37]Cochran-Mantel-Haenszel
Comparison: Week 9p-value: 0.082395% CI: [0.76, 18.07]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.000295% CI: [2.51, 35.02]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.019795% CI: [1.2, 18.1]Cochran-Mantel-Haenszel
Comparison: Week 10p-value: 0.039295% CI: [0.99, 15.69]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: <0.000195% CI: [3.18, 61.09]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: 0.003695% CI: [1.72, 42.37]Cochran-Mantel-Haenszel
Comparison: Week 11p-value: 0.063895% CI: [0.81, 24.23]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.000395% CI: [1.98, 13.11]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.000595% CI: [2.28, 32.07]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.037995% CI: [1.03, 16.19]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.336795% CI: [0.46, 8.78]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: 0.000395% CI: [2.46, 38.51]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: 0.001795% CI: [1.82, 24.75]Cochran-Mantel-Haenszel
Comparison: Week 13p-value: 0.083195% CI: [0.79, 10.83]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.000195% CI: [2.58, 28.06]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.008795% CI: [1.41, 15.94]Cochran-Mantel-Haenszel
Comparison: Week 14p-value: 0.136195% CI: [0.73, 9.37]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: <0.000195% CI: [3.08, 44.56]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: 0.005895% CI: [1.51, 21.75]Cochran-Mantel-Haenszel
Comparison: Week 15p-value: 0.103695% CI: [0.77, 13.03]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [5.35, 948.31]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.001995% CI: [1.62, 83.47]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.011795% CI: [1.14, 68.26]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: <0.000195% CI: [2.46, 19.76]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: 0.017395% CI: [1.23, 10.74]Cochran-Mantel-Haenszel
Comparison: Week 17p-value: 0.259895% CI: [0.63, 6]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.040295% CI: [1.05, 8.02]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.200395% CI: [0.7, 5.51]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.003495% CI: [1.52, 9.67]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.074995% CI: [0.92, 5.8]Cochran-Mantel-Haenszel
Comparison: Week 19p-value: 0.124895% CI: [0.82, 5.02]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.027895% CI: [1.09, 6.03]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.700195% CI: [0.48, 2.97]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.784495% CI: [0.46, 2.84]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.024995% CI: [1.12, 6.44]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.030395% CI: [1.09, 6.54]Cochran-Mantel-Haenszel
Comparison: Week 21p-value: 0.260195% CI: [0.69, 4.12]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.069195% CI: [0.94, 5.46]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.053895% CI: [0.98, 5.52]Cochran-Mantel-Haenszel
Comparison: Week 22p-value: 0.625895% CI: [0.52, 2.94]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.740795% CI: [0.5, 2.63]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.521895% CI: [0.57, 3.06]Cochran-Mantel-Haenszel
Comparison: Week 23p-value: 0.985595% CI: [0.43, 2.34]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.740795% CI: [0.5, 2.68]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.184395% CI: [0.76, 4.17]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.636495% CI: [0.54, 2.77]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.920695% CI: [0.45, 2.4]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.647395% CI: [0.52, 2.87]Cochran-Mantel-Haenszel
Comparison: Week 25p-value: 0.873395% CI: [0.4, 2.15]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.73895% CI: [0.5, 2.68]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.376895% CI: [0.63, 3.43]Cochran-Mantel-Haenszel
Comparison: Week 26p-value: 0.936395% CI: [0.45, 2.41]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.455895% CI: [0.6, 3.18]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.488395% CI: [0.57, 3.24]Cochran-Mantel-Haenszel
Comparison: Week 27p-value: 0.69795% CI: [0.36, 1.96]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.460195% CI: [0.6, 3.16]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.375895% CI: [0.63, 3.51]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.724895% CI: [0.36, 2.02]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.45595% CI: [0.6, 3.11]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.367295% CI: [0.64, 3.35]Cochran-Mantel-Haenszel
Comparison: Week 29p-value: 0.91295% CI: [0.47, 2.35]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.350695% CI: [0.65, 3.35]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.496995% CI: [0.58, 3.16]Cochran-Mantel-Haenszel
Comparison: Week 30p-value: 0.926595% CI: [0.42, 2.19]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.24495% CI: [0.72, 3.79]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.482995% CI: [0.59, 3.15]Cochran-Mantel-Haenszel
Comparison: Week 31p-value: 0.738295% CI: [0.51, 2.61]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.883395% CI: [0.47, 2.41]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.938595% CI: [0.44, 2.41]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.597595% CI: [0.35, 1.82]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.449195% CI: [0.61, 3.13]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.234895% CI: [0.72, 4.05]Cochran-Mantel-Haenszel
Comparison: Week 33p-value: 0.908795% CI: [0.46, 2.38]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.334995% CI: [0.66, 3.42]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.480695% CI: [0.58, 3.17]Cochran-Mantel-Haenszel
Comparison: Week 34p-value: 0.899895% CI: [0.42, 2.15]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.461895% CI: [0.6, 3.12]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.615495% CI: [0.53, 2.93]Cochran-Mantel-Haenszel
Comparison: Week 35p-value: 0.944295% CI: [0.45, 2.34]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.45895% CI: [0.6, 3.08]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.627595% CI: [0.52, 2.95]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.355895% CI: [0.65, 3.36]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.474995% CI: [0.6, 3.04]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.367295% CI: [0.64, 3.46]Cochran-Mantel-Haenszel
Comparison: Week 37p-value: 0.346295% CI: [0.65, 3.37]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.585695% CI: [0.56, 2.82]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.356395% CI: [0.64, 3.58]Cochran-Mantel-Haenszel
Comparison: Week 38p-value: 0.616595% CI: [0.54, 2.82]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.453295% CI: [0.6, 3.1]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.469195% CI: [0.58, 3.27]Cochran-Mantel-Haenszel
Comparison: Week 39p-value: 0.370395% CI: [0.64, 3.32]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.931995% CI: [0.43, 2.15]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.637495% CI: [0.52, 2.94]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.345795% CI: [0.65, 3.42]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.890695% CI: [0.47, 2.37]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.788295% CI: [0.47, 2.68]Cochran-Mantel-Haenszel
Comparison: Week 41p-value: 0.789895% CI: [0.49, 2.59]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.60195% CI: [0.55, 2.84]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.733195% CI: [0.36, 2.03]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.568695% CI: [0.35, 1.78]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.952195% CI: [0.44, 2.18]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.600195% CI: [0.53, 3.05]Cochran-Mantel-Haenszel
Comparison: Week 42p-value: 0.605495% CI: [0.55, 2.8]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.604295% CI: [0.36, 1.81]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.346595% CI: [0.64, 3.73]Cochran-Mantel-Haenszel
Comparison: Week 43p-value: 0.742795% CI: [0.5, 2.64]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.921895% CI: [0.47, 2.3]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.490995% CI: [0.57, 3.3]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.361695% CI: [0.65, 3.31]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.757895% CI: [0.51, 2.55]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.236995% CI: [0.71, 4.24]Cochran-Mantel-Haenszel
Comparison: Week 45p-value: 0.877495% CI: [0.41, 2.12]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.757895% CI: [0.51, 2.55]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.469195% CI: [0.58, 3.33]Cochran-Mantel-Haenszel
Comparison: Week 46p-value: 0.727295% CI: [0.38, 1.95]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.90895% CI: [0.47, 2.35]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.600195% CI: [0.53, 3.05]Cochran-Mantel-Haenszel
Comparison: Week 47p-value: 0.559995% CI: [0.35, 1.76]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.927495% CI: [0.43, 2.17]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.933395% CI: [0.44, 2.47]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.779695% CI: [0.5, 2.5]Cochran-Mantel-Haenszel
Comparison: Week 49p-value: 0.886195% CI: [0.46, 2.44]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.973295% CI: [0.43, 2.4]Cochran-Mantel-Haenszel
Comparison: Week 50p-value: 0.937895% CI: [0.46, 2.32]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.579995% CI: [0.55, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.97995% CI: [0.42, 2.44]Cochran-Mantel-Haenszel
Comparison: Week 51p-value: 0.729995% CI: [0.51, 2.64]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.735795% CI: [0.51, 2.64]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.324395% CI: [0.28, 1.51]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.436495% CI: [0.32, 1.63]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 2 | 4.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 4 | 12.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 8 | 19.1 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 12 | 27.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 16 | 34.0 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 18 | 46.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 20 | 44.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 32 | 48.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 48 | 53.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 52 | 53.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 8 | 12.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 48 | 60.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 12 | 25.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 16 | 34.0 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 18 | 41.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 20 | 46.5 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 52 | 55.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 32 | 51.2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 2 | 6.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 4 | 10.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 32 | 36.2 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 20 | 31.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 52 | 46.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 2 | 4.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 12 | 14.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 18 | 29.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 48 | 38.3 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 4 | 8.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 16 | 25.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 8 | 8.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 16 | 12.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 32 | 52.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 18 | 19.6 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 52 | 60.9 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 20 | 30.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 4 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 8 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 12 | 12.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time | Week 48 | 56.5 percentage of participants |
Comparison: Week 2p-value: 0.567395% CI: [0.18, 22.87]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.313995% CI: [0.31, 32.21]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.619795% CI: [0.16, 22.83]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.04895% CI: [0.8, 60.25]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.094595% CI: [0.62, 48.12]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.174595% CI: [0.45, 40.6]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.023395% CI: [1.1, 27.25]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.142295% CI: [0.63, 16.53]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.48195% CI: [0.31, 11.77]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.062895% CI: [0.93, 8.6]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.114995% CI: [0.8, 6.87]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.972695% CI: [0.3, 3.48]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.013495% CI: [1.28, 11]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.014895% CI: [1.21, 9.06]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.161195% CI: [0.73, 6.71]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.006195% CI: [1.44, 9.6]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.022895% CI: [1.13, 7.18]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.333195% CI: [0.61, 4.37]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.171895% CI: [0.78, 4.38]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.121995% CI: [0.83, 4.66]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.975595% CI: [0.4, 2.45]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.757995% CI: [0.38, 2.02]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.921395% CI: [0.42, 2.19]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.100195% CI: [0.21, 1.14]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.794595% CI: [0.39, 2.05]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.721495% CI: [0.51, 2.69]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.072795% CI: [0.2, 1.07]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.487195% CI: [0.32, 1.72]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.603795% CI: [0.35, 1.85]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.132395% CI: [0.23, 1.22]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time
PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Non-responders imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 2 | 6.4 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 4 | 14.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 8 | 27.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 12 | 31.9 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 16 | 38.3 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 18 | 46.7 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 20 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 32 | 55.6 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 48 | 57.8 percentage of participants |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 52 | 53.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 8 | 21.3 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 48 | 62.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 12 | 31.9 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 16 | 40.4 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 18 | 48.8 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 20 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 52 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 32 | 58.1 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 2 | 2 percentage of participants |
| Phase 2a - Placebo SC QW | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 4 | 10.6 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 32 | 46.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 20 | 34.0 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 52 | 48.9 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 2 | 6.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 12 | 12.8 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 18 | 27.7 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 48 | 40.4 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 4 | 8.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 16 | 25.5 percentage of participants |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 8 | 8.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 16 | 12.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 32 | 54.3 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 18 | 17.4 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 52 | 58.7 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 20 | 26.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 4 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 8 | 4.2 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 12 | 12.5 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 2 | 2.1 percentage of participants |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time | Week 48 | 58.7 percentage of participants |
Comparison: Week 2p-value: 0.313795% CI: [0.31, 33.17]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.598295% CI: [0.16, 25.75]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.324495% CI: [0.31, 25.38]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.026695% CI: [0.96, 59.86]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.089295% CI: [0.63, 42.8]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.186495% CI: [0.44, 37.67]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00295% CI: [1.89, 45.55]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.014195% CI: [1.28, 32.22]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.448595% CI: [0.34, 10.89]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.023595% CI: [1.14, 9.55]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.025295% CI: [1.13, 9.59]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.906295% CI: [0.27, 3.14]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.004195% CI: [1.57, 13.19]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.002595% CI: [1.66, 13.39]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.163295% CI: [0.73, 6.76]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.00395% CI: [1.57, 10.65]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.001495% CI: [1.8, 13.91]Cochran-Mantel-Haenszel
Comparison: Week 18p-value: 0.301795% CI: [0.62, 4.82]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.001895% CI: [1.67, 10.48]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.001795% CI: [1.69, 10.99]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.536595% CI: [0.52, 3.55]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.877495% CI: [0.46, 2.46]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.726195% CI: [0.5, 2.7]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.419595% CI: [0.31, 1.63]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.975995% CI: [0.42, 2.31]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.685795% CI: [0.51, 2.81]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.063395% CI: [0.19, 1.04]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.646695% CI: [0.36, 1.88]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.929895% CI: [0.41, 2.23]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.314395% CI: [0.29, 1.49]Cochran-Mantel-Haenszel
Secondary
Phase 2b: Percent Change From Baseline in ItchyQoL Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; WOCF: Baseline through Week 52.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 32 | -43.5 percentage change | Standard Error 4.04 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 20 | -39.9 percentage change | Standard Error 3.6 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 52 | -44.5 percentage change | Standard Error 4.19 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 16 | -36.4 percentage change | Standard Error 3.45 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 12 | -34.0 percentage change | Standard Error 3.66 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 8 | -32.8 percentage change | Standard Error 3.18 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 48 | -44.4 percentage change | Standard Error 4.16 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 18 | -39.3 percentage change | Standard Error 3.69 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 4 | -25.4 percentage change | Standard Error 2.88 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 18 | -34.8 percentage change | Standard Error 3.76 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 32 | -36.4 percentage change | Standard Error 4.2 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 20 | -35.8 percentage change | Standard Error 3.74 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 8 | -21.8 percentage change | Standard Error 3.11 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 4 | -17.2 percentage change | Standard Error 2.93 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 12 | -28.4 percentage change | Standard Error 3.7 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 52 | -43.0 percentage change | Standard Error 4.31 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 48 | -38.3 percentage change | Standard Error 4.2 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 16 | -29.5 percentage change | Standard Error 3.51 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 18 | -26.7 percentage change | Standard Error 3.87 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 4 | -13.8 percentage change | Standard Error 2.97 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 8 | -13.6 percentage change | Standard Error 3.14 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 12 | -17.7 percentage change | Standard Error 3.87 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 16 | -21.1 percentage change | Standard Error 3.56 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 20 | -30.3 percentage change | Standard Error 3.77 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 32 | -33.5 percentage change | Standard Error 4.21 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 48 | -34.4 percentage change | Standard Error 4.04 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 52 | -37.7 percentage change | Standard Error 4.3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 32 | -31.3 percentage change | Standard Error 4.07 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 16 | -8.3 percentage change | Standard Error 3.55 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 12 | -6.5 percentage change | Standard Error 3.84 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 52 | -36.3 percentage change | Standard Error 4.26 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 48 | -36.2 percentage change | Standard Error 4.11 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 8 | -5.0 percentage change | Standard Error 3.14 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 20 | -28.2 percentage change | Standard Error 3.79 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 18 | -20.3 percentage change | Standard Error 4.06 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in ItchyQoL Over Time | Week 4 | -0.6 percentage change | Standard Error 2.83 |
Comparison: Week 4p-value: <0.000195% CI: [-32.8, -16.9]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-24.6, -8.6]ANCOVA
Comparison: Week 4p-value: 0.001395% CI: [-21.2, -5.3]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-36.5, -19.1]ANCOVA
Comparison: Week 8p-value: 0.000295% CI: [-25.4, -8.2]ANCOVA
Comparison: Week 8p-value: 0.051195% CI: [-17.2, 0]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-37.8, -17.1]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-32.3, -11.5]ANCOVA
Comparison: Week 12p-value: 0.038695% CI: [-21.8, -0.6]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-37.8, -18.4]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-31, -11.5]ANCOVA
Comparison: Week 16p-value: 0.010895% CI: [-22.5, -3]ANCOVA
Comparison: Week 18p-value: 0.000695% CI: [-29.6, -8.4]ANCOVA
Comparison: Week 18p-value: 0.008495% CI: [-25.3, -3.8]ANCOVA
Comparison: Week 18p-value: 0.242295% CI: [-17.1, 4.4]ANCOVA
Comparison: Week 20p-value: 0.024995% CI: [-21.9, -1.5]ANCOVA
Comparison: Week 20p-value: 0.149795% CI: [-17.9, 2.8]ANCOVA
Comparison: Week 20p-value: 0.69195% CI: [-12.4, 8.2]ANCOVA
Comparison: Week 32p-value: 0.033195% CI: [-23.4, -1]ANCOVA
Comparison: Week 32p-value: 0.370995% CI: [-16.6, 6.2]ANCOVA
Comparison: Week 32p-value: 0.692495% CI: [-13.7, 9.1]ANCOVA
Comparison: Week 48p-value: 0.158395% CI: [-19.6, 3.2]ANCOVA
Comparison: Week 48p-value: 0.719395% CI: [-13.5, 9.3]ANCOVA
Comparison: Week 48p-value: 0.758995% CI: [-9.4, 12.9]ANCOVA
Comparison: Week 52p-value: 0.164295% CI: [-20, 3.4]ANCOVA
Comparison: Week 52p-value: 0.261195% CI: [-18.4, 5]ANCOVA
Comparison: Week 52p-value: 0.807695% CI: [-13.2, 10.3]ANCOVA
Secondary
Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time
Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). A score was set to missing after a participant received prohibited/rescue medication that potentially impact efficacy analyses prior to Week 16, and the participant's worst post baseline observation before the time of the medication usage was carried forward (WOCF) to impute missing endpoint value (for participants whose postbaseline values were all missing, the baseline was used to impute). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 18, 20, 32, 48, 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; WOCF: Baseline through Week 52.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -66.4 percentage change | Standard Error 10.57 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -50.6 percentage change | Standard Error 10.74 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -57.4 percentage change | Standard Error 9.75 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -62.4 percentage change | Standard Error 19.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -64.9 percentage change | Standard Error 9.83 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -63.6 percentage change | Standard Error 26.46 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -36.7 percentage change | Standard Error 15.47 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -67.8 percentage change | Standard Error 10.85 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -71.2 percentage change | Standard Error 10.88 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -55.1 percentage change | Standard Error 11.14 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -56.5 percentage change | Standard Error 11.17 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -24.9 percentage change | Standard Error 25.73 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -67.3 percentage change | Standard Error 11.19 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -65.4 percentage change | Standard Error 11.43 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -48.2 percentage change | Standard Error 15.12 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -46.1 percentage change | Standard Error 19.73 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -46.3 percentage change | Standard Error 10.02 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -44.7 percentage change | Standard Error 11.35 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -30.2 percentage change | Standard Error 11.03 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -56.8 percentage change | Standard Error 10.36 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | -25.3 percentage change | Standard Error 15.39 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -55.0 percentage change | Standard Error 11.41 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -37.0 percentage change | Standard Error 10.39 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -29.0 percentage change | Standard Error 11.9 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | -18.1 percentage change | Standard Error 11.34 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -49.9 percentage change | Standard Error 10.66 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | -26.7 percentage change | Standard Error 20.58 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | -28.5 percentage change | Standard Error 27.03 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -41.8 percentage change | Standard Error 11.14 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -28.6 percentage change | Standard Error 10.11 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 16 | -12.3 percentage change | Standard Error 9.98 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 2 | 81.4 percentage change | Standard Error 25.3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 4 | 25.2 percentage change | Standard Error 10.53 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 8 | 5.9 percentage change | Standard Error 15.22 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 12 | 25.6 percentage change | Standard Error 20.17 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 52 | -49.3 percentage change | Standard Error 11.03 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 18 | -22.4 percentage change | Standard Error 12.24 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 20 | -27.6 percentage change | Standard Error 10.3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 32 | -38.3 percentage change | Standard Error 10.6 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time | Week 48 | -44.0 percentage change | Standard Error 10.75 |
Comparison: Week 2p-value: 0.000195% CI: [-216.6, -73.3]ANCOVA
Comparison: Week 2p-value: 0.003595% CI: [-177.2, -35.5]ANCOVA
Comparison: Week 2p-value: 0.003195% CI: [-182.2, -37.6]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-105.2, -46.4]ANCOVA
Comparison: Week 4p-value: 0.000395% CI: [-85.3, -25.5]ANCOVA
Comparison: Week 4p-value: 0.005395% CI: [-73.5, -13.1]ANCOVA
Comparison: Week 8p-value: 0.047295% CI: [-84.6, -0.5]ANCOVA
Comparison: Week 8p-value: 0.011595% CI: [-95.7, -12.3]ANCOVA
Comparison: Week 8p-value: 0.145395% CI: [-73.2, 10.9]ANCOVA
Comparison: Week 12p-value: 0.001795% CI: [-142.5, -33.6]ANCOVA
Comparison: Week 12p-value: 0.01195% CI: [-126.8, -16.7]ANCOVA
Comparison: Week 12p-value: 0.068195% CI: [-108.5, 3.9]ANCOVA
Comparison: Week 16p-value: 0.001395% CI: [-72.3, -17.8]ANCOVA
Comparison: Week 16p-value: 0.016195% CI: [-61.5, -6.4]ANCOVA
Comparison: Week 16p-value: 0.246695% CI: [-44, 11.4]ANCOVA
Comparison: Week 18p-value: 0.045195% CI: [-64.6, -0.7]ANCOVA
Comparison: Week 18p-value: 0.17795% CI: [-54.8, 10.2]ANCOVA
Comparison: Week 18p-value: 0.689395% CI: [-39.3, 26.1]ANCOVA
Comparison: Week 20p-value: 0.008795% CI: [-65, -9.6]ANCOVA
Comparison: Week 20p-value: 0.043995% CI: [-57.7, -0.8]ANCOVA
Comparison: Week 20p-value: 0.51195% CI: [-37.8, 18.9]ANCOVA
Comparison: Week 32p-value: 0.059295% CI: [-57.2, 1.1]ANCOVA
Comparison: Week 32p-value: 0.232795% CI: [-48.3, 11.8]ANCOVA
Comparison: Week 32p-value: 0.817395% CI: [-33.5, 26.4]ANCOVA
Comparison: Week 48p-value: 0.072595% CI: [-57.1, 2.5]ANCOVA
Comparison: Week 48p-value: 0.128595% CI: [-53.5, 6.8]ANCOVA
Comparison: Week 48p-value: 0.691195% CI: [-35.2, 23.4]ANCOVA
Comparison: Week 52p-value: 0.228395% CI: [-48.6, 11.7]ANCOVA
Comparison: Week 52p-value: 0.304995% CI: [-46.9, 14.8]ANCOVA
Comparison: Week 52p-value: 0.717295% CI: [-36.6, 25.2]ANCOVA
Secondary
Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time
Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
Time frame: Baseline, Weeks 1 through 52
Population: mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -75.1 percentage change | Standard Error 5.24 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -67.1 percentage change | Standard Error 5.31 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -51.7 percentage change | Standard Error 4.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -75.2 percentage change | Standard Error 5.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -67.8 percentage change | Standard Error 5.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -68.5 percentage change | Standard Error 5.25 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -40.2 percentage change | Standard Error 3.83 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -75.2 percentage change | Standard Error 5.29 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -70.8 percentage change | Standard Error 5.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -78.2 percentage change | Standard Error 5.15 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -70.7 percentage change | Standard Error 5.21 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -54.0 percentage change | Standard Error 4.58 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -73.9 percentage change | Standard Error 5.34 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -70.3 percentage change | Standard Error 5.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -19.6 percentage change | Standard Error 2.56 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -72.2 percentage change | Standard Error 5.31 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -72.7 percentage change | Standard Error 5.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -72.3 percentage change | Standard Error 5.29 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -55.0 percentage change | Standard Error 4.63 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -77.6 percentage change | Standard Error 4.99 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -55.2 percentage change | Standard Error 4.77 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -56.0 percentage change | Standard Error 4.76 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -45.1 percentage change | Standard Error 4 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -78.0 percentage change | Standard Error 5.09 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -56.6 percentage change | Standard Error 4.8 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -57.1 percentage change | Standard Error 4.91 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -33.2 percentage change | Standard Error 3.6 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -76.0 percentage change | Standard Error 4.99 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -57.5 percentage change | Standard Error 4.81 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -77.3 percentage change | Standard Error 5.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -56.5 percentage change | Standard Error 4.88 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -47.8 percentage change | Standard Error 3.98 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -76.9 percentage change | Standard Error 4.92 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -60.3 percentage change | Standard Error 5.02 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -61.3 percentage change | Standard Error 5.03 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -75.6 percentage change | Standard Error 5.08 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -62.3 percentage change | Standard Error 5.06 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -62.2 percentage change | Standard Error 5.1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -49.5 percentage change | Standard Error 4.1 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -72.9 percentage change | Standard Error 5.08 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -63.1 percentage change | Standard Error 5.23 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -63.3 percentage change | Standard Error 5.32 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -75.8 percentage change | Standard Error 5.05 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -63.7 percentage change | Standard Error 5.47 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -78.7 percentage change | Standard Error 5.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -64.2 percentage change | Standard Error 5.39 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -50.1 percentage change | Standard Error 4.26 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -74.7 percentage change | Standard Error 5.17 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -64.8 percentage change | Standard Error 5.35 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -65.4 percentage change | Standard Error 5.3 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -79.1 percentage change | Standard Error 5.27 |
| Phase 2a - Vixarelimab 360 mg SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -64.2 percentage change | Standard Error 5.25 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -58.2 percentage change | Standard Error 5.27 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -65.3 percentage change | Standard Error 5.46 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -73.8 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -71.0 percentage change | Standard Error 5.27 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -52.9 percentage change | Standard Error 4.93 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -65.0 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -66.2 percentage change | Standard Error 5.44 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -70.8 percentage change | Standard Error 5.21 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -65.0 percentage change | Standard Error 5.37 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -68.4 percentage change | Standard Error 5.3 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -42.1 percentage change | Standard Error 4.3 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -69.5 percentage change | Standard Error 5.25 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -52.1 percentage change | Standard Error 4.83 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -67.5 percentage change | Standard Error 5.39 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -62.2 percentage change | Standard Error 5.37 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -73.7 percentage change | Standard Error 5.05 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -38.2 percentage change | Standard Error 4.02 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -68.5 percentage change | Standard Error 5.3 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -51.2 percentage change | Standard Error 4.9 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -68.8 percentage change | Standard Error 5.3 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -71.2 percentage change | Standard Error 5.15 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -67.9 percentage change | Standard Error 5.21 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -64.3 percentage change | Standard Error 7.41 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -62.3 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -57.2 percentage change | Standard Error 5.14 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -68.3 percentage change | Standard Error 5.19 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -34.2 percentage change | Standard Error 3.94 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -68.2 percentage change | Standard Error 5.29 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -70.5 percentage change | Standard Error 5.15 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -68.9 percentage change | Standard Error 5.3 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -45.9 percentage change | Standard Error 4.48 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -12.5 percentage change | Standard Error 2.56 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -57.9 percentage change | Standard Error 5.2 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -67.2 percentage change | Standard Error 5.23 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -25.4 percentage change | Standard Error 3.83 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -74.4 percentage change | Standard Error 5.09 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -21.9 percentage change | Standard Error 3.57 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -49.4 percentage change | Standard Error 4.59 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -72.8 percentage change | Standard Error 5.76 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -41.3 percentage change | Standard Error 4.18 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -71.4 percentage change | Standard Error 5.28 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -49.5 percentage change | Standard Error 4.79 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -75.7 percentage change | Standard Error 5.66 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -72.4 percentage change | Standard Error 5.13 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -59.9 percentage change | Standard Error 5.24 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -46.8 percentage change | Standard Error 4.78 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -72.8 percentage change | Standard Error 5.4 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -73.0 percentage change | Standard Error 5.06 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -62.7 percentage change | Standard Error 5.49 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -51.6 percentage change | Standard Error 4.82 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -29.7 percentage change | Standard Error 3.96 |
| Phase 2a - Placebo SC QW | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -74.0 percentage change | Standard Error 5.02 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -60.5 percentage change | Standard Error 5 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -10.0 percentage change | Standard Error 2.6 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -21.4 percentage change | Standard Error 3.62 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -19.9 percentage change | Standard Error 3.88 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -16.9 percentage change | Standard Error 4.01 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -23.2 percentage change | Standard Error 3.99 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -28.0 percentage change | Standard Error 4.08 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -27.1 percentage change | Standard Error 4.24 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -26.0 percentage change | Standard Error 4.37 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -31.1 percentage change | Standard Error 4.55 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -36.0 percentage change | Standard Error 4.61 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -32.5 percentage change | Standard Error 4.75 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -29.2 percentage change | Standard Error 4.74 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -35.6 percentage change | Standard Error 4.78 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -36.7 percentage change | Standard Error 4.89 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -36.2 percentage change | Standard Error 4.79 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -33.3 percentage change | Standard Error 4.85 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -43.0 percentage change | Standard Error 5.04 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -45.5 percentage change | Standard Error 5 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -50.8 percentage change | Standard Error 5.08 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -50.9 percentage change | Standard Error 5.07 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -54.3 percentage change | Standard Error 5.09 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -53.3 percentage change | Standard Error 5.12 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -56.2 percentage change | Standard Error 5.21 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -55.6 percentage change | Standard Error 5.23 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -57.2 percentage change | Standard Error 5.18 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -57.4 percentage change | Standard Error 5.19 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -59.7 percentage change | Standard Error 5.23 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -58.3 percentage change | Standard Error 5.35 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -59.9 percentage change | Standard Error 5.1 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -60.3 percentage change | Standard Error 5.18 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -61.3 percentage change | Standard Error 5.09 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -60.3 percentage change | Standard Error 5.12 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -60.4 percentage change | Standard Error 5.16 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -61.8 percentage change | Standard Error 5.1 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -62.5 percentage change | Standard Error 5.03 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -64.0 percentage change | Standard Error 5.04 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -63.6 percentage change | Standard Error 4.99 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -65.7 percentage change | Standard Error 5.02 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -65.9 percentage change | Standard Error 5.02 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -68.3 percentage change | Standard Error 5.05 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -67.0 percentage change | Standard Error 4.93 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -68.0 percentage change | Standard Error 4.96 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -67.8 percentage change | Standard Error 4.97 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -65.4 percentage change | Standard Error 4.86 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -65.2 percentage change | Standard Error 4.92 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -66.1 percentage change | Standard Error 5.02 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -66.8 percentage change | Standard Error 5 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -65.5 percentage change | Standard Error 5.37 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -68.8 percentage change | Standard Error 5.36 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -69.4 percentage change | Standard Error 5.25 |
| Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -64.8 percentage change | Standard Error 5.33 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 26 | -51.8 percentage change | Standard Error 5.08 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 25 | -53.0 percentage change | Standard Error 5.13 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 49 | -67.3 percentage change | Standard Error 4.92 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 40 | -59.6 percentage change | Standard Error 4.87 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 24 | -50.5 percentage change | Standard Error 5.16 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 23 | -50.6 percentage change | Standard Error 5.18 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 6 | -10.5 percentage change | Standard Error 3.97 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 41 | -62.3 percentage change | Standard Error 4.88 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 22 | -47.4 percentage change | Standard Error 5.1 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 21 | -45.7 percentage change | Standard Error 5.07 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 5 | -9.6 percentage change | Standard Error 3.89 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 42 | -62.7 percentage change | Standard Error 4.82 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 20 | -40.6 percentage change | Standard Error 5.06 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 19 | -38.1 percentage change | Standard Error 5.02 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 1 | -5.1 percentage change | Standard Error 2.53 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 43 | -62.1 percentage change | Standard Error 4.78 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 18 | -31.4 percentage change | Standard Error 4.99 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 17 | -25.1 percentage change | Standard Error 4.98 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 50 | -66.8 percentage change | Standard Error 5.16 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 44 | -63.4 percentage change | Standard Error 4.8 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 16 | -14.8 percentage change | Standard Error 4.77 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 15 | -14.9 percentage change | Standard Error 4.75 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 4 | -9.1 percentage change | Standard Error 3.91 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 45 | -62.8 percentage change | Standard Error 4.71 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 14 | -15.3 percentage change | Standard Error 4.85 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 13 | -17.9 percentage change | Standard Error 4.74 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 3 | -8.2 percentage change | Standard Error 3.78 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 46 | -64.3 percentage change | Standard Error 4.76 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 12 | -14.6 percentage change | Standard Error 4.71 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 11 | -14.3 percentage change | Standard Error 4.72 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 52 | -67.0 percentage change | Standard Error 5.08 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 47 | -65.2 percentage change | Standard Error 4.86 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 10 | -14.3 percentage change | Standard Error 4.58 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 9 | -13.3 percentage change | Standard Error 4.48 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 51 | -64.6 percentage change | Standard Error 5.08 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 35 | -56.5 percentage change | Standard Error 4.9 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 34 | -55.5 percentage change | Standard Error 4.96 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 33 | -56.1 percentage change | Standard Error 4.85 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 48 | -64.9 percentage change | Standard Error 4.71 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 36 | -56.3 percentage change | Standard Error 4.88 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 32 | -54.9 percentage change | Standard Error 4.88 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 31 | -55.1 percentage change | Standard Error 4.95 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 8 | -11.7 percentage change | Standard Error 4.3 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 37 | -58.0 percentage change | Standard Error 4.96 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 30 | -52.7 percentage change | Standard Error 4.98 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 29 | -54.1 percentage change | Standard Error 4.95 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 7 | -11.0 percentage change | Standard Error 4.17 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 38 | -59.1 percentage change | Standard Error 4.97 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 28 | -51.6 percentage change | Standard Error 5.03 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 27 | -51.9 percentage change | Standard Error 5.03 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 2 | -7.9 percentage change | Standard Error 3.52 |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Week 39 | -59.3 percentage change | Standard Error 4.87 |
Comparison: Week 1p-value: <0.000195% CI: [-21.6, -7.5]ANCOVA
Comparison: Week 1p-value: 0.036895% CI: [-14.5, -0.5]ANCOVA
Comparison: Week 1p-value: 0.1795% CI: [-12, 2.1]ANCOVA
Comparison: Week 2p-value: <0.000195% CI: [-35.1, -15.3]ANCOVA
Comparison: Week 2p-value: 0.005695% CI: [-23.7, -4.1]ANCOVA
Comparison: Week 2p-value: 0.007695% CI: [-23.3, -3.6]ANCOVA
Comparison: Week 3p-value: <0.000195% CI: [-42.5, -21.5]ANCOVA
Comparison: Week 3p-value: 0.001495% CI: [-27.7, -6.7]ANCOVA
Comparison: Week 3p-value: 0.029695% CI: [-22.3, -1.2]ANCOVA
Comparison: Week 4p-value: <0.000195% CI: [-46.9, -25]ANCOVA
Comparison: Week 4p-value: 0.000295% CI: [-31.4, -9.7]ANCOVA
Comparison: Week 4p-value: 0.165295% CI: [-18.6, 3.2]ANCOVA
Comparison: Week 5p-value: <0.000195% CI: [-49.1, -27.3]ANCOVA
Comparison: Week 5p-value: <0.000195% CI: [-35.3, -13.7]ANCOVA
Comparison: Week 5p-value: 0.014695% CI: [-24.5, -2.7]ANCOVA
Comparison: Week 6p-value: <0.000195% CI: [-50.2, -27.8]ANCOVA
Comparison: Week 6p-value: <0.000195% CI: [-38.8, -16.7]ANCOVA
Comparison: Week 6p-value: 0.002295% CI: [-28.5, -6.4]ANCOVA
Comparison: Week 7p-value: <0.000195% CI: [-50.8, -27.4]ANCOVA
Comparison: Week 7p-value: <0.000195% CI: [-41.8, -18.8]ANCOVA
Comparison: Week 7p-value: 0.006995% CI: [-27.7, -4.5]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-52.1, -28]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-42.3, -18.5]ANCOVA
Comparison: Week 8p-value: 0.019495% CI: [-26.2, -2.3]ANCOVA
Comparison: Week 9p-value: <0.000195% CI: [-53.2, -28.1]ANCOVA
Comparison: Week 9p-value: <0.000195% CI: [-44.9, -20.1]ANCOVA
Comparison: Week 9p-value: 0.005495% CI: [-30.2, -5.3]ANCOVA
Comparison: Week 10p-value: <0.000195% CI: [-53.4, -27.9]ANCOVA
Comparison: Week 10p-value: <0.000195% CI: [-47.8, -22.5]ANCOVA
Comparison: Week 10p-value: 0.000995% CI: [-34.4, -9.1]ANCOVA
Comparison: Week 11p-value: <0.000195% CI: [-54.1, -27.8]ANCOVA
Comparison: Week 11p-value: <0.000195% CI: [-48.3, -22.1]ANCOVA
Comparison: Week 11p-value: 0.006795% CI: [-31.2, -5.1]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-54.5, -28.2]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-45.3, -19.1]ANCOVA
Comparison: Week 12p-value: 0.027995% CI: [-27.6, -1.6]ANCOVA
Comparison: Week 13p-value: <0.000195% CI: [-51.9, -25.4]ANCOVA
Comparison: Week 13p-value: <0.000195% CI: [-46.7, -20.5]ANCOVA
Comparison: Week 13p-value: 0.008595% CI: [-30.8, -4.6]ANCOVA
Comparison: Week 14p-value: <0.000195% CI: [-55.4, -28.4]ANCOVA
Comparison: Week 14p-value: <0.000195% CI: [-51.1, -24.1]ANCOVA
Comparison: Week 14p-value: 0.00295% CI: [-34.8, -8]ANCOVA
Comparison: Week 15p-value: <0.000195% CI: [-55.9, -29.4]ANCOVA
Comparison: Week 15p-value: <0.000195% CI: [-50.4, -24]ANCOVA
Comparison: Week 15p-value: 0.001695% CI: [-34.5, -8.2]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-55, -28.3]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-49.7, -23.1]ANCOVA
Comparison: Week 16p-value: 0.006795% CI: [-31.7, -5.2]ANCOVA
Comparison: Week 17p-value: <0.000195% CI: [-49, -21.4]ANCOVA
Comparison: Week 17p-value: <0.000195% CI: [-46, -18.1]ANCOVA
Comparison: Week 17p-value: 0.011195% CI: [-31.7, -4.1]ANCOVA
Comparison: Week 18p-value: <0.000195% CI: [-43.8, -16.1]ANCOVA
Comparison: Week 18p-value: 0.000395% CI: [-40.6, -12.5]ANCOVA
Comparison: Week 18p-value: 0.044595% CI: [-27.8, -0.4]ANCOVA
Comparison: Week 19p-value: 0.000895% CI: [-38.1, -10.2]ANCOVA
Comparison: Week 19p-value: 0.002795% CI: [-36, -7.7]ANCOVA
Comparison: Week 19p-value: 0.072495% CI: [-26.7, 1.2]ANCOVA
Comparison: Week 20p-value: 0.002895% CI: [-35.7, -7.6]ANCOVA
Comparison: Week 20p-value: 0.015895% CI: [-31.9, -3.3]ANCOVA
Comparison: Week 20p-value: 0.146895% CI: [-24.2, 3.6]ANCOVA
Comparison: Week 21p-value: 0.016795% CI: [-31.7, -3.2]ANCOVA
Comparison: Week 21p-value: 0.024295% CI: [-31, -2.2]ANCOVA
Comparison: Week 21p-value: 0.22495% CI: [-22.6, 5.3]ANCOVA
Comparison: Week 22p-value: 0.03195% CI: [-30.3, -1.5]ANCOVA
Comparison: Week 22p-value: 0.043795% CI: [-29.4, -0.4]ANCOVA
Comparison: Week 22p-value: 0.412395% CI: [-19.9, 8.2]ANCOVA
Comparison: Week 23p-value: 0.080895% CI: [-27.8, 1.6]ANCOVA
Comparison: Week 23p-value: 0.106495% CI: [-26.8, 2.6]ANCOVA
Comparison: Week 23p-value: 0.436695% CI: [-19.9, 8.6]ANCOVA
Comparison: Week 24p-value: 0.064495% CI: [-28.3, 0.8]ANCOVA
Comparison: Week 26p-value: 0.44295% CI: [-19.6, 8.6]ANCOVA
Comparison: Week 24p-value: 0.063395% CI: [-28.5, 0.8]ANCOVA
Comparison: Week 24p-value: 0.477595% CI: [-19.4, 9.1]ANCOVA
Comparison: Week 25p-value: 0.110695% CI: [-26.2, 2.7]ANCOVA
Comparison: Week 25p-value: 0.104395% CI: [-26.4, 2.5]ANCOVA
Comparison: Week 25p-value: 0.56395% CI: [-18.4, 10]ANCOVA
Comparison: Week 26p-value: 0.062995% CI: [-27.9, 0.7]ANCOVA
Comparison: Week 26p-value: 0.052395% CI: [-28.8, 0.1]ANCOVA
Comparison: Week 27p-value: 0.090895% CI: [-26.4, 2]ANCOVA
Comparison: Week 27p-value: 0.068895% CI: [-27.9, 1]ANCOVA
Comparison: Week 27p-value: 0.280295% CI: [-21.9, 6.4]ANCOVA
Comparison: Week 28p-value: 0.033795% CI: [-29.8, -1.2]ANCOVA
Comparison: Week 28p-value: 0.067395% CI: [-27.8, 1]ANCOVA
Comparison: Week 28p-value: 0.356495% CI: [-21.1, 7.6]ANCOVA
Comparison: Week 29p-value: 0.055895% CI: [-27.6, 0.3]ANCOVA
Comparison: Week 29p-value: 0.047195% CI: [-28.5, -0.2]ANCOVA
Comparison: Week 29p-value: 0.410195% CI: [-19.7, 8.1]ANCOVA
Comparison: Week 30p-value: 0.028795% CI: [-29.9, -1.7]ANCOVA
Comparison: Week 30p-value: 0.042795% CI: [-29.1, -0.5]ANCOVA
Comparison: Week 30p-value: 0.282895% CI: [-21.7, 6.4]ANCOVA
Comparison: Week 31p-value: 0.029495% CI: [-29.7, -1.6]ANCOVA
Comparison: Week 31p-value: 0.063695% CI: [-27.5, 0.8]ANCOVA
Comparison: Week 31p-value: 0.381295% CI: [-20, 7.7]ANCOVA
Comparison: Week 32p-value: 0.02795% CI: [-29.7, -1.8]ANCOVA
Comparison: Week 32p-value: 0.067995% CI: [-26.9, 1]ANCOVA
Comparison: Week 32p-value: 0.445295% CI: [-19.2, 8.5]ANCOVA
Comparison: Week 33p-value: 0.046795% CI: [-28.2, -0.2]ANCOVA
Comparison: Week 33p-value: 0.082995% CI: [-26.1, 1.6]ANCOVA
Comparison: Week 33p-value: 0.526395% CI: [-18, 9.2]ANCOVA
Comparison: Week 34p-value: 0.02195% CI: [-31, -2.6]ANCOVA
Comparison: Week 34p-value: 0.062395% CI: [-27.6, 0.7]ANCOVA
Comparison: Week 34p-value: 0.489995% CI: [-18.9, 9.1]ANCOVA
Comparison: Week 35p-value: 0.028195% CI: [-29.9, -1.7]ANCOVA
Comparison: Week 35p-value: 0.131895% CI: [-24.7, 3.3]ANCOVA
Comparison: Week 35p-value: 0.445895% CI: [-19.1, 8.5]ANCOVA
Comparison: Week 36p-value: 0.022995% CI: [-30.4, -2.3]ANCOVA
Comparison: Week 36p-value: 0.097895% CI: [-25.9, 2.2]ANCOVA
Comparison: Week 36p-value: 0.379295% CI: [-19.8, 7.6]ANCOVA
Comparison: Week 37p-value: 0.02995% CI: [-30.2, -1.7]ANCOVA
Comparison: Week 37p-value: 0.130695% CI: [-25, 3.3]ANCOVA
Comparison: Week 37p-value: 0.392395% CI: [-19.8, 7.8]ANCOVA
Comparison: Week 38p-value: 0.026595% CI: [-30.3, -1.9]ANCOVA
Comparison: Week 38p-value: 0.145695% CI: [-24.5, 3.6]ANCOVA
Comparison: Week 38p-value: 0.513895% CI: [-18.3, 9.2]ANCOVA
Comparison: Week 39p-value: 0.026595% CI: [-29.8, -1.9]ANCOVA
Comparison: Week 39p-value: 0.098695% CI: [-25.7, 2.2]ANCOVA
Comparison: Week 39p-value: 0.3695% CI: [-20, 7.3]ANCOVA
Comparison: Week 40p-value: 0.030395% CI: [-29.5, -1.5]ANCOVA
Comparison: Week 40p-value: 0.097995% CI: [-25.7, 2.2]ANCOVA
Comparison: Week 40p-value: 0.366495% CI: [-19.9, 7.4]ANCOVA
Comparison: Week 41p-value: 0.080695% CI: [-26.3, 1.5]ANCOVA
Comparison: Week 41p-value: 0.22695% CI: [-22.4, 5.3]ANCOVA
Comparison: Week 41p-value: 0.383595% CI: [-19.7, 7.6]ANCOVA
Comparison: Week 42p-value: 0.059495% CI: [-26.7, 0.5]ANCOVA
Comparison: Week 42p-value: 0.218995% CI: [-22.2, 5.1]ANCOVA
Comparison: Week 42p-value: 0.523895% CI: [-17.8, 9.1]ANCOVA
Comparison: Week 43p-value: 0.120495% CI: [-24.5, 2.9]ANCOVA
Comparison: Week 43p-value: 0.112995% CI: [-24.4, 2.6]ANCOVA
Comparison: Week 43p-value: 0.391195% CI: [-19.3, 7.6]ANCOVA
Comparison: Week 44p-value: 0.078495% CI: [-26, 1.4]ANCOVA
Comparison: Week 44p-value: 0.304695% CI: [-20.7, 6.5]ANCOVA
Comparison: Week 44p-value: 0.520595% CI: [-17.9, 9.1]ANCOVA
Comparison: Week 45p-value: 0.038895% CI: [-27.3, -0.7]ANCOVA
Comparison: Week 45p-value: 0.110595% CI: [-24.2, 2.5]ANCOVA
Comparison: Week 45p-value: 0.703995% CI: [-15.7, 10.7]ANCOVA
Comparison: Week 46p-value: 0.088595% CI: [-25.2, 1.8]ANCOVA
Comparison: Week 46p-value: 0.153595% CI: [-23.1, 3.7]ANCOVA
Comparison: Week 46p-value: 0.897595% CI: [-14.2, 12.5]ANCOVA
Comparison: Week 47p-value: 0.067495% CI: [-26.6, 0.9]ANCOVA
Comparison: Week 47p-value: 0.302595% CI: [-20.8, 6.5]ANCOVA
Comparison: Week 47p-value: 0.896495% CI: [-14.5, 12.7]ANCOVA
Comparison: Week 48p-value: 0.063395% CI: [-26.1, 0.7]ANCOVA
Comparison: Week 48p-value: 0.166595% CI: [-22.9, 4]ANCOVA
Comparison: Week 48p-value: 0.774895% CI: [-15.3, 11.4]ANCOVA
Comparison: Week 49p-value: 0.123995% CI: [-24.8, 3]ANCOVA
Comparison: Week 49p-value: 0.364795% CI: [-20.7, 7.6]ANCOVA
Comparison: Week 49p-value: 0.805695% CI: [-12.5, 16]ANCOVA
Comparison: Week 50p-value: 0.107995% CI: [-26.4, 2.6]ANCOVA
Comparison: Week 50p-value: 0.417495% CI: [-20.6, 8.6]ANCOVA
Comparison: Week 50p-value: 0.781595% CI: [-16.7, 12.6]ANCOVA
Comparison: Week 51p-value: 0.080295% CI: [-27, 1.6]ANCOVA
Comparison: Week 51p-value: 0.138695% CI: [-25.9, 3.6]ANCOVA
Comparison: Week 51p-value: 0.510195% CI: [-19.2, 9.6]ANCOVA
Comparison: Week 52p-value: 0.097295% CI: [-26.5, 2.2]ANCOVA
Comparison: Week 52p-value: 0.445495% CI: [-20.9, 9.2]ANCOVA
Comparison: Week 52p-value: 0.763895% CI: [-12.2, 16.6]ANCOVA