Acne Vulgaris
Conditions
Keywords
LI-36 Receptor, Interleukin 36, Imsidolimab
Brief summary
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.
Interventions
DRUGImsidolimab
Humanized Monoclonal Antibody
BIOLOGICALPlacebo
Placebo
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of moderate to severe facial AV * Facial IGA) score of 3 (moderate) or 4 (severe) * At least 20 and no more than 100 inflammatory lesions on the face * No more than 100 non-inflammatory lesions on the face. * No more than 5 nodules (≥5 millimeter \[mm\]) on the face Key
Exclusion criteria
* A participant with acne fulminans or conglobate or secondary acne will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Baseline, Week 12 | The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Baseline, Weeks 2, 4, 8, and 20 | The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12 and 20 | The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The Facial IGA was a global assessment that was used to assess the current state of acne vulgaris (AV) on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count. |
| Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment. |
| Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | PGI- S was a single-item question, which asks the participant to rate the current severity of AV. The response options were: Clear Skin (1) Mild (2) Moderate (3) Severe (4) Higher score indicated more severity. |
| Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | PGI-C was a single-item, self-administered questionnaire, which asked the participant to rate the change in their symptom severity. Scores ranged from 1 (Very much better) to 7 (Very much worse). Very much better (1) Much better (2) A little better (3) No change (4) A little worse (5) Much worse (6) Very much worse (7) Higher score indicated more severity. |
| Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | DLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The DLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The DLQI was administered to participants ≥ 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1. |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | CDLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The CDLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The CDLQI was administered to participants \< 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | First dose of study drug until end of study (up to 20 weeks) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment that did not necessarily have a causal relationship with treatment. An AE was considered serious if it resulted in death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. TEAE was defined as a new event that occurred during or after first dose of study treatment or any event present at baseline that worsens in either intensity or frequency after first dose of study treatment. |
| Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | The Facial IGA was a global assessment that was used to assess the current state of AV on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imsidolimab 400/200 mg Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | 42 |
| Imsidolimab 200/100 mg Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | 40 |
| Placebo Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. | 41 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 1 |
| Overall Study | Other | 1 | 1 | 0 |
| Overall Study | Used of Prohibited Medication or Treatment | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 1 |
Baseline characteristics
| Characteristic | Imsidolimab 400/200 mg | Total | Placebo | Imsidolimab 200/100 mg |
|---|---|---|---|---|
| Age, Continuous | 19.3 years STANDARD_DEVIATION 5.58 | 20.3 years STANDARD_DEVIATION 6.89 | 21.0 years STANDARD_DEVIATION 7.62 | 20.7 years STANDARD_DEVIATION 7.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 41 Participants | 11 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 82 Participants | 30 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Facial inflammatory Lesion Count | 29.5 lesions STANDARD_DEVIATION 8.12 | 28.5 lesions STANDARD_DEVIATION 9.42 | 26.9 lesions STANDARD_DEVIATION 7.11 | 29.0 lesions STANDARD_DEVIATION 12.34 |
| Facial Investigator's Global Assessment (IGA) score | 3.1 units on a scale STANDARD_DEVIATION 0.35 | 3.1 units on a scale STANDARD_DEVIATION 0.32 | 3.1 units on a scale STANDARD_DEVIATION 0.33 | 3.1 units on a scale STANDARD_DEVIATION 0.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 22 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 93 Participants | 31 Participants | 28 Participants |
| Sex: Female, Male Female | 24 Participants | 80 Participants | 26 Participants | 30 Participants |
| Sex: Female, Male Male | 18 Participants | 43 Participants | 15 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 8 / 41 | 6 / 39 | 6 / 41 |
| serious Total, serious adverse events | 1 / 41 | 0 / 39 | 0 / 41 |
Outcome results
Primary
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Week 12
Population: Participants in ITT Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | -6.8 lesions | Standard Deviation 13.63 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | -7.4 lesions | Standard Deviation 16.38 |
| Placebo | Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | -9.6 lesions | Standard Deviation 10.66 |
Comparison: Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.p-value: 0.375790% CI: [-2.47, 8.19]LRMM
Comparison: LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.p-value: 0.618390% CI: [-3.73, 6.95]LRMM
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
CDLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The CDLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The CDLQI was administered to participants \< 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -2.3 units on a scale | Standard Deviation 4.46 |
| Imsidolimab 400/200 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -1.8 units on a scale | Standard Deviation 4.52 |
| Imsidolimab 400/200 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -1.6 units on a scale | Standard Deviation 3.7 |
| Imsidolimab 400/200 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -0.3 units on a scale | Standard Deviation 2.9 |
| Imsidolimab 400/200 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -3.1 units on a scale | Standard Deviation 4.44 |
| Imsidolimab 200/100 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -2.2 units on a scale | Standard Deviation 6.48 |
| Imsidolimab 200/100 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -0.7 units on a scale | Standard Deviation 9 |
| Imsidolimab 200/100 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -2.7 units on a scale | Standard Deviation 6.31 |
| Imsidolimab 200/100 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -1.1 units on a scale | Standard Deviation 7.2 |
| Imsidolimab 200/100 mg | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -3.5 units on a scale | Standard Deviation 7.33 |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -2.8 units on a scale | Standard Deviation 4.71 |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -3.2 units on a scale | Standard Deviation 4.67 |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -2.0 units on a scale | Standard Deviation 5.07 |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -2.9 units on a scale | Standard Deviation 4.85 |
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -2.6 units on a scale | Standard Deviation 4.69 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.933390% CI: [-2.69, 2.97]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.397290% CI: [-1.4, 4.27]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.066290% CI: [0.23, 3.99]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.889890% CI: [-1.73, 2.04]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.366490% CI: [-0.85, 2.82]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.065590% CI: [0.25, 4.05]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.692190% CI: [-1.61, 2.57]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.040690% CI: [0.59, 4.88]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.687290% CI: [-2.24, 1.38]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.339290% CI: [-0.81, 2.92]LRMM
Secondary
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
DLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The DLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The DLQI was administered to participants ≥ 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -4.2 units on a scale | Standard Deviation 4.71 |
| Imsidolimab 400/200 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -3.4 units on a scale | Standard Deviation 5.28 |
| Imsidolimab 400/200 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -1.6 units on a scale | Standard Deviation 4.53 |
| Imsidolimab 400/200 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -2.6 units on a scale | Standard Deviation 5.01 |
| Imsidolimab 400/200 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -1.8 units on a scale | Standard Deviation 5.75 |
| Imsidolimab 200/100 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -4.0 units on a scale | Standard Deviation 6.26 |
| Imsidolimab 200/100 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -1.9 units on a scale | Standard Deviation 5.28 |
| Imsidolimab 200/100 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -3.6 units on a scale | Standard Deviation 5.2 |
| Imsidolimab 200/100 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -2.9 units on a scale | Standard Deviation 5.14 |
| Imsidolimab 200/100 mg | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -3.7 units on a scale | Standard Deviation 4.11 |
| Placebo | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -4.7 units on a scale | Standard Deviation 5.69 |
| Placebo | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -4.0 units on a scale | Standard Deviation 4.98 |
| Placebo | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -2.0 units on a scale | Standard Deviation 3.37 |
| Placebo | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -4.3 units on a scale | Standard Deviation 4.93 |
| Placebo | Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -2.3 units on a scale | Standard Deviation 4.19 |
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.436590% CI: [-0.99, 2.73]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.854390% CI: [-1.92, 1.54]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.872690% CI: [-1.91, 1.58]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.793290% CI: [-1.56, 2.14]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.598390% CI: [-1.22, 2.35]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.339690% CI: [-0.77, 2.86]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.530590% CI: [-2.23, 1.01]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.081990% CI: [0.09, 3.29]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.024390% CI: [0.69, 4.31]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.106190% CI: [-0.03, 3.46]LRMM
Secondary
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 2 | -1.9 lesions | Standard Deviation 7.87 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 4 | -0.3 lesions | Standard Deviation 15.21 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 8 | -5.5 lesions | Standard Deviation 10.75 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 20 | -8.7 lesions | Standard Deviation 11.42 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 20 | -12.0 lesions | Standard Deviation 16.58 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 2 | -0.5 lesions | Standard Deviation 7.3 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 8 | -6.2 lesions | Standard Deviation 12.43 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 4 | -4.4 lesions | Standard Deviation 9.87 |
| Placebo | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 20 | -11.7 lesions | Standard Deviation 9 |
| Placebo | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 4 | -8.0 lesions | Standard Deviation 9.64 |
| Placebo | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 8 | -7.8 lesions | Standard Deviation 12.4 |
| Placebo | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Change at Week 2 | -3.8 lesions | Standard Deviation 7.04 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.24990% CI: [-0.85, 4.8]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.070890% CI: [0.28, 5.99]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.00490% CI: [3.44, 12.34]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.20690% CI: [-1.05, 7.94]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.434190% CI: [-2.33, 6.51]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.730790% CI: [-3.59, 5.48]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.326190% CI: [-1.97, 7.77]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.822190% CI: [-5.56, 4.23]LRMM
Secondary
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
The Facial IGA was a global assessment that was used to assess the current state of acne vulgaris (AV) on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -0.6 units on a scale | Standard Deviation 0.78 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -0.2 units on a scale | Standard Deviation 0.49 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -0.7 units on a scale | Standard Deviation 0.91 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -0.2 units on a scale | Standard Deviation 0.46 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -0.4 units on a scale | Standard Deviation 0.62 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -0.0 units on a scale | Standard Deviation 0.16 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -0.3 units on a scale | Standard Deviation 0.54 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -0.3 units on a scale | Standard Deviation 0.53 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -0.7 units on a scale | Standard Deviation 0.8 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -0.1 units on a scale | Standard Deviation 0.42 |
| Placebo | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -0.9 units on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -0.5 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -0.6 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -0.8 units on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -0.2 units on a scale | Standard Deviation 0.43 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.515790% CI: [-0.08, 0.19]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.017890% CI: [0.06, 0.34]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.013290% CI: [0.1, 0.48]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.003490% CI: [0.16, 0.54]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.05190% CI: [0.04, 0.47]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.060890% CI: [0.03, 0.47]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.270290% CI: [-0.1, 0.48]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.024990% CI: [0.11, 0.69]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.185390% CI: [-0.06, 0.55]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.297490% CI: [-0.11, 0.5]LRMM
Secondary
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -6.6 lesions | Standard Deviation 20.18 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -6.5 lesions | Standard Deviation 21.57 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -2.2 lesions | Standard Deviation 11.28 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -4.7 lesions | Standard Deviation 11.87 |
| Imsidolimab 400/200 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -9.9 lesions | Standard Deviation 15.31 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -2.2 lesions | Standard Deviation 16.65 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -0.9 lesions | Standard Deviation 9.95 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -4.3 lesions | Standard Deviation 10.15 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -4.5 lesions | Standard Deviation 17.89 |
| Imsidolimab 200/100 mg | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -4.0 lesions | Standard Deviation 20.9 |
| Placebo | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -11.0 lesions | Standard Deviation 15.01 |
| Placebo | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -9.4 lesions | Standard Deviation 16.96 |
| Placebo | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -3.2 lesions | Standard Deviation 14.07 |
| Placebo | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -8.1 lesions | Standard Deviation 15.3 |
| Placebo | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -6.4 lesions | Standard Deviation 14.98 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.422990% CI: [-2.16, 6.24]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.602790% CI: [-2.91, 5.59]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.265590% CI: [-1.35, 6.95]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.622990% CI: [-2.95, 5.44]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.409190% CI: [-3.1, 9.3]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.127490% CI: [-0.47, 12.25]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.207590% CI: [-1.47, 11.01]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.248490% CI: [-1.88, 10.64]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.339990% CI: [-2.53, 9.45]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.054590% CI: [1.03, 13.05]LRMM
Secondary
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -5.0 lesions | Standard Deviation 21.03 |
| Imsidolimab 400/200 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -12.0 lesions | Standard Deviation 28 |
| Imsidolimab 400/200 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -18.6 lesions | Standard Deviation 22.01 |
| Imsidolimab 400/200 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -13.4 lesions | Standard Deviation 26.82 |
| Imsidolimab 400/200 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -4.1 lesions | Standard Deviation 15.03 |
| Imsidolimab 200/100 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -11.9 lesions | Standard Deviation 29.06 |
| Imsidolimab 200/100 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -8.7 lesions | Standard Deviation 16.32 |
| Imsidolimab 200/100 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -1.3 lesions | Standard Deviation 11.95 |
| Imsidolimab 200/100 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -8.4 lesions | Standard Deviation 23.85 |
| Imsidolimab 200/100 mg | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -16.0 lesions | Standard Deviation 31.82 |
| Placebo | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 20 | -22.7 lesions | Standard Deviation 18.65 |
| Placebo | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 8 | -15.9 lesions | Standard Deviation 19.5 |
| Placebo | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 12 | -19.0 lesions | Standard Deviation 21.24 |
| Placebo | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 2 | -7.0 lesions | Standard Deviation 12.36 |
| Placebo | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Change at Week 4 | -14.4 lesions | Standard Deviation 15.22 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.21590% CI: [-1.21, 8.56]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.086490% CI: [0.21, 10.05]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.008490% CI: [3.97, 16.85]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.1690% CI: [-0.95, 12.01]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.367190% CI: [-3.94, 13.41]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.158790% CI: [-1.28, 16.46]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.193290% CI: [-2.03, 17.21]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.251890% CI: [-2.95, 16.37]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.23290% CI: [-2.53, 15.83]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.201490% CI: [-2.08, 16.35]LRMM
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment that did not necessarily have a causal relationship with treatment. An AE was considered serious if it resulted in death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. TEAE was defined as a new event that occurred during or after first dose of study treatment or any event present at baseline that worsens in either intensity or frequency after first dose of study treatment.
Time frame: First dose of study drug until end of study (up to 20 weeks)
Population: Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Imsidolimab 400/200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAEs | 18 participants |
| Imsidolimab 400/200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Serious TEAEs | 1 participants |
| Imsidolimab 200/100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAEs | 10 participants |
| Imsidolimab 200/100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Serious TEAEs | 0 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAEs | 11 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Serious TEAEs | 0 participants |
Secondary
Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20
The Facial IGA was a global assessment that was used to assess the current state of AV on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Imsidolimab 400/200 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 20 | 14.3 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 8 | 2.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 2 | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 12 | 11.8 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 4 | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 8 | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 2 | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 4 | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 12 | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 20 | 8.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 20 | 18.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 12 | 13.9 percentage of participants |
| Placebo | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 4 | 2.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 8 | 2.6 percentage of participants |
| Placebo | Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 | Week 2 | 0 percentage of participants |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.33990% CI: [-6.62, 1.63]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.324390% CI: [-6.79, 1.59]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 190% CI: [-5.91, 5.91]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.33290% CI: [-6.96, 1.63]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.759590% CI: [-15.5, 10.59]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.020990% CI: [-23.66, -4.57]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.609490% CI: [-18.99, 9.87]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.207690% CI: [-23.34, 2.78]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
PGI-C was a single-item, self-administered questionnaire, which asked the participant to rate the change in their symptom severity. Scores ranged from 1 (Very much better) to 7 (Very much worse). Very much better (1) Much better (2) A little better (3) No change (4) A little worse (5) Much worse (6) Very much worse (7) Higher score indicated more severity.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little worse | 8.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little better | 47.1 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much worse | 2.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much better | 5.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much better | 20.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much worse | 2.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much better | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much better | 5.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much better | 5.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: No change | 20.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much worse | 5.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little better | 55.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much worse | 2.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little better | 47.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much worse | 5.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little worse | 7.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: No change | 15.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little better | 40.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: No change | 20.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much worse | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much better | 28.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little worse | 15.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little worse | 13.2 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much better | 2.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much worse | 2.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much worse | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much better | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much worse | 2.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much better | 7.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much worse | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little worse | 5.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little better | 47.4 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much better | 17.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: No change | 14.7 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: No change | 26.3 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much worse | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much better | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much worse | 10.5 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much better | 2.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little worse | 16.2 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much better | 2.6 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little better | 50.0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: No change | 18.4 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little worse | 18.4 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much better | 13.5 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little better | 37.8 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: No change | 18.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much worse | 8.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much worse | 2.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much better | 2.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much better | 14.3 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little better | 40.0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: No change | 22.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little worse | 17.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much worse | 2.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much worse | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much better | 2.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much better | 22.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little better | 31.4 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: No change | 17.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little worse | 14.3 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much worse | 8.6 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much worse | 2.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much better | 11.4 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much better | 17.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little better | 40.0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: No change | 20.0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little worse | 8.6 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much worse | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much worse | 2.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much better | 2.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little better | 47.2 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little better | 56.4 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: No change | 16.7 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much better | 15.4 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: No change | 15.8 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: A little worse | 2.8 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much better | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much better | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much worse | 2.8 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: Very much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little worse | 10.5 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little worse | 10.5 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much better | 10.5 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: No change | 34.2 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: No change | 13.2 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little better | 50.0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: No change | 15.4 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: A little worse | 2.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much better | 31.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Much better | 34.2 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much better | 2.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 2: A little better | 52.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 8: Very much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Very much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: Very much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Very much better | 5.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: Much worse | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 20: A little better | 28.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 12: Much better | 25.0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 | Week 4: A little worse | 12.8 percentage of participants |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.833890% CI: [-0.19, 0.2]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.114290% CI: [-0.31, 0.09]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.343390% CI: [-0.38, 0]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.112990% CI: [-0.37, 0.04]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.284290% CI: [-0.38, 0]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.021290% CI: [-0.52, -0.13]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.766590% CI: [-0.28, 0.14]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.177790% CI: [-0.42, 0]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.374190% CI: [-0.33, 0.09]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.332190% CI: [-0.33, 0.09]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
PGI- S was a single-item question, which asks the participant to rate the current severity of AV. The response options were: Clear Skin (1) Mild (2) Moderate (3) Severe (4) Higher score indicated more severity.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Mild | 25.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Severe | 8.6 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Severe | 10.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Mild | 26.3 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Severe | 20.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Clear Skin | 5.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Moderate | 44.1 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Clear Skin | 0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Mild | 54.3 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Mild | 41.2 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Severe | 10.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Clear Skin | 2.9 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Moderate | 63.2 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Clear Skin | 2.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Moderate | 34.3 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Mild | 27.5 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Moderate | 55.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Severe | 8.8 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Moderate | 60.0 percentage of participants |
| Imsidolimab 400/200 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Clear Skin | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Moderate | 45.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Mild | 42.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Clear Skin | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Moderate | 51.4 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Severe | 5.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Clear Skin | 2.9 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Clear Skin | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Mild | 57.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Moderate | 34.3 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Severe | 5.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Moderate | 63.2 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Severe | 13.2 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Mild | 21.6 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Moderate | 70.3 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Mild | 23.7 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Severe | 8.1 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Clear Skin | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Mild | 48.6 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Clear Skin | 0 percentage of participants |
| Imsidolimab 200/100 mg | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Severe | 5.7 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Severe | 5.3 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Clear Skin | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Mild | 21.1 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Clear Skin | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Mild | 33.3 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Moderate | 47.4 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Clear Skin | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Severe | 2.8 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Moderate | 28.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Moderate | 50.0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 2: Severe | 28.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Moderate | 48.7 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 4: Severe | 17.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Clear Skin | 0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Mild | 44.7 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 8: Severe | 7.9 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Mild | 50.0 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 12: Moderate | 47.2 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Clear Skin | 2.6 percentage of participants |
| Placebo | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Week 20: Mild | 63.2 percentage of participants |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.448290% CI: [-0.1, 0.29]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.452990% CI: [-0.05, 0.33]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.93290% CI: [-0.2, 0.18]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.315190% CI: [-0.22, 0.16]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.290890% CI: [-0.32, 0.06]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.727790% CI: [-0.15, 0.24]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.846390% CI: [-0.23, 0.17]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.528190% CI: [-0.28, 0.11]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.574790% CI: [-0.28, 0.11]Cochran-Mantel-Haenszel
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.508190% CI: [-0.24, 0.14]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -6.6 percent change | Standard Deviation 27.87 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -2.9 percent change | Standard Deviation 44 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -21.50 percent change | Standard Deviation 33.89 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -26.8 percent change | Standard Deviation 42.68 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -34.3 percent change | Standard Deviation 37.5 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -20.5 percent change | Standard Deviation 53.96 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -19.6 percent change | Standard Deviation 39.15 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -36.4 percent change | Standard Deviation 48.53 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -1.9 percent change | Standard Deviation 27.37 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -14.1 percent change | Standard Deviation 31.98 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -46.9 percent change | Standard Deviation 32.95 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -29.3 percent change | Standard Deviation 33.39 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -37.6 percent change | Standard Deviation 40.73 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -13.6 percent change | Standard Deviation 25.76 |
| Placebo | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -28.4 percent change | Standard Deviation 42.87 |
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.1990% CI: [-3.74, 32.74]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.300890% CI: [-3.84, 16.73]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.087890% CI: [0.4, 21.19]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.00290% CI: [12.64, 40.57]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.102990% CI: [-0.12, 28.09]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.542790% CI: [-9.25, 20.02]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.583390% CI: [-10.05, 20.02]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.329390% CI: [-7.46, 28.99]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.216890% CI: [-3.91, 27.23]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.408990% CI: [-7.82, 23.45]LRMM
Secondary
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -2.4 percent change | Standard Deviation 68.07 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -7.7 percent change | Standard Deviation 84.17 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -1.0 percent change | Standard Deviation 37.86 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -6.8 percent change | Standard Deviation 37.46 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -21.1 percent change | Standard Deviation 46.59 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | 11.4 percent change | Standard Deviation 117.96 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | 1.0 percent change | Standard Deviation 49.8 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -8.7 percent change | Standard Deviation 45.48 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | 8.8 percent change | Standard Deviation 114.44 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -0.9 percent change | Standard Deviation 95.05 |
| Placebo | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -31.4 percent change | Standard Deviation 50.91 |
| Placebo | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -22.1 percent change | Standard Deviation 40.26 |
| Placebo | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | 1.1 percent change | Standard Deviation 67.11 |
| Placebo | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -18.1 percent change | Standard Deviation 32.73 |
| Placebo | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -12.7 percent change | Standard Deviation 45.88 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.967990% CI: [-19.86, 18.91]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.915290% CI: [-20.87, 18.35]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.44990% CI: [-8.67, 23.32]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.724690% CI: [-12.72, 19.6]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.465590% CI: [-17.49, 45.14]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.117890% CI: [-1.59, 62.54]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.193890% CI: [-6.22, 52.52]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.099190% CI: [0.08, 59.29]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.333790% CI: [-10.62, 40.59]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.046590% CI: [5.5, 56.87]LRMM
Secondary
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imsidolimab 400/200 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -18.9 percent change | Standard Deviation 39.18 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -28.6 percent change | Standard Deviation 33.69 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -18.9 percent change | Standard Deviation 40.88 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -7.7 percent change | Standard Deviation 29.1 |
| Imsidolimab 400/200 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -6.9 percent change | Standard Deviation 21.26 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -1.9 percent change | Standard Deviation 21.62 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -12.7 percent change | Standard Deviation 31.36 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -13.5 percent change | Standard Deviation 22.61 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -23.0 percent change | Standard Deviation 56.3 |
| Imsidolimab 200/100 mg | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -15.4 percent change | Standard Deviation 44.85 |
| Placebo | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 20 | -38.7 percent change | Standard Deviation 30 |
| Placebo | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 2 | -10.7 percent change | Standard Deviation 22.27 |
| Placebo | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 4 | -23.2 percent change | Standard Deviation 23.87 |
| Placebo | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 8 | -24.0 percent change | Standard Deviation 27.82 |
| Placebo | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Percent Change at Week 12 | -31.2 percent change | Standard Deviation 31.88 |
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 2p-value: 0.436190% CI: [-4.34, 12.06]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 2p-value: 0.101890% CI: [-0.04, 16.48]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 4p-value: 0.005990% CI: [6.66, 25.88]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 4p-value: 0.091390% CI: [0.26, 19.59]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 8p-value: 0.492190% CI: [-7.47, 18.09]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 8p-value: 0.160790% CI: [-1.95, 24.24]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 12p-value: 0.124490% CI: [-1.02, 29.48]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 12p-value: 0.100490% CI: [-0.02, 30.51]LRMM
Comparison: Imsidolimab 400/200 mg vs Placebo: Week 20p-value: 0.201590% CI: [-3.61, 28.39]LRMM
Comparison: Imsidolimab 200/100 mg vs Placebo: Week 20p-value: 0.105790% CI: [-0.27, 31.81]LRMM