Chronic Idiopathic Pruritus, Chronic Idiopathic Urticaria, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
Conditions
Keywords
pruritus, chronic pruritus, moderate to severe
Brief summary
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
Interventions
DRUGKPL-716
A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.
DRUGPlacebo
Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
Sponsors
Kiniksa Pharmaceuticals, Ltd.
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18 to 75 years 2. Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months 3. Moderate to severe pruritus 4. Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration 5. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
Exclusion criteria
1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study 2. Is currently using medication known to cause pruritus 3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion 4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit 5. Has an active infection, including skin infection 6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
| Percent Change From Baseline in Pruritus VAS Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
| Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
| Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
| Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Baseline, Weeks 1-18 | Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort. |
| Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1-18 | Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. |
| Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Baseline, Weeks 1-18 | Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort |
| Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Percent Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. |
| Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Baseline, Weeks 1-18 | Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. |
| Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1-18 | Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. |
| Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1-18 | Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Baseline, Weeks 4, 8, 12, 16, 18 | The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked Over the last week, has your skin prevented you from working or studying? If answered yes, score=3; If no, a second question will be asked: Over the last week how much has your skin been a problem at work or studying? If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. |
| Percent Change From Baseline in DLQI Total Score Over Time | Baseline, Weeks 4, 8, 12, 16, 18 | The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked Over the last week, has your skin prevented you from working or studying? If answered yes, score=3; If no, a second question will be asked: Over the last week how much has your skin been a problem at work or studying? If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. |
| Change From Baseline in ItchyQoL Total Score Over Time | Baseline, Weeks 4, 8, 12, 16, 18 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
| Percent Change From Baseline in ItchyQoL Total Score Over Time | Baseline, Weeks 4, 8, 12, 16, 18 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
| Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. |
| Percent Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Countries
United States
Participant flow
Pre-assignment details
This study assigned participants to active treatment or placebo in 5 individual disease-specific cohorts: chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs). The participant flow data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.
Participants by arm
| Arm | Count |
|---|---|
| KPL-716 KPL-716 weekly for 8 weeks | 39 |
| Placebo Placebo weekly for 8 weeks | 19 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other, Not Specified | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | KPL-716 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 11.51 | 53.3 years STANDARD_DEVIATION 13.94 | 53.2 years STANDARD_DEVIATION 12.24 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 20 Participants | 5 Participants | 25 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 19 Participants | 14 Participants | 33 Participants |
| Race/Ethnicity, Customized White | 34 Participants | 14 Participants | 48 Participants |
| Sex: Female, Male Female | 27 Participants | 14 Participants | 41 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 17 Participants |
| Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS) | 8.1 score on a scale STANDARD_DEVIATION 0.93 | 8.3 score on a scale STANDARD_DEVIATION 1.14 | 8.2 score on a scale STANDARD_DEVIATION 1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 19 |
| other Total, other adverse events | 15 / 39 | 11 / 19 |
| serious Total, serious adverse events | 1 / 39 | 0 / 19 |
Outcome results
Primary
Change From Baseline in Weekly Average WI-NRS at Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 8
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -4.3 score on a scale | Standard Error 1.84 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -1.1 score on a scale | Standard Error 2.66 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -4.3 score on a scale | Standard Error 0.77 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -3.7 score on a scale | Standard Error 0.96 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -3.1 score on a scale | Standard Error 0.82 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -6.9 score on a scale | Standard Error 0.81 |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | 0.7 score on a scale | Standard Error 1.84 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -5.6 score on a scale | Standard Error 0.69 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS at Week 8 | -2.5 score on a scale | Standard Error 0.98 |
p-value: 0.39880% CI: [-8.68, 2.17]ANCOVA
p-value: 0.665380% CI: [-2.17, 1.09]ANCOVA
p-value: 0.071180% CI: [-11.63, -3.56]ANCOVA
p-value: 0.018680% CI: [-4.7, -1.51]ANCOVA
Primary
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 8
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -50.7 percent change | Standard Error 21.56 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -19.0 percent change | Standard Error 31.07 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -52.4 percent change | Standard Error 9.32 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -48.8 percent change | Standard Error 11.63 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -39.4 percent change | Standard Error 10.21 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -85.0 percent change | Standard Error 11.76 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | 7.0 percent change | Standard Error 26.8 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -66.5 percent change | Standard Error 7.78 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | -29.0 percent change | Standard Error 11 |
p-value: 0.473480% CI: [-95.11, 31.76]ANCOVA
p-value: 0.81380% CI: [-23.33, 16.18]ANCOVA
p-value: 0.097980% CI: [-150.6, -33.32]ANCOVA
p-value: 0.012280% CI: [-55.48, -19.61]ANCOVA
Secondary
Change From Baseline in 5-D Pruritus Total Score Over Time
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -8.5 units on a scale | Standard Error 2.02 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -8.3 units on a scale | Standard Error 2.17 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -7.8 units on a scale | Standard Error 2.1 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -4.0 units on a scale | Standard Error 3.37 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -7.0 units on a scale | Standard Error 2.42 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -8.0 units on a scale | Standard Error 1.68 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -6.3 units on a scale | Standard Error 2.78 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -6.5 units on a scale | Standard Error 2.5 |
| KPL-716: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -7.5 units on a scale | Standard Error 2.22 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | 0.5 units on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | 0.5 units on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | 0.5 units on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | 0.5 units on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -0.5 units on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -1.0 units on a scale | Standard Error 1 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | 0.0 units on a scale | Standard Error 0 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -7.1 units on a scale | Standard Error 1.77 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -6.6 units on a scale | Standard Error 1.5 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -6.6 units on a scale | Standard Error 1.23 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -6.5 units on a scale | Standard Error 1.32 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -6.3 units on a scale | Standard Error 1.33 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -6.7 units on a scale | Standard Error 1.08 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -6.3 units on a scale | Standard Error 1.82 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -4.4 units on a scale | Standard Error 1.06 |
| KPL-716: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -4.5 units on a scale | Standard Error 1.27 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -5.4 units on a scale | Standard Error 1.65 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -7.9 units on a scale | Standard Error 0.63 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -4.0 units on a scale | Standard Error 1.35 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -4.6 units on a scale | Standard Error 1.42 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -6.8 units on a scale | Standard Error 1.23 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -6.1 units on a scale | Standard Error 1.17 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -5.8 units on a scale | Standard Error 1.47 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -5.0 units on a scale | Standard Error 1.47 |
| Placebo: CIP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -6.3 units on a scale | Standard Error 1.04 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -7.3 units on a scale | Standard Error 4.06 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -8.0 units on a scale | Standard Error 4.16 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -2.3 units on a scale | Standard Error 1.2 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -12.0 units on a scale | Standard Error 2 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -8.0 units on a scale | Standard Error 4.16 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -13.5 units on a scale | Standard Error 3.5 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -12.0 units on a scale | Standard Error 2 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -11.5 units on a scale | Standard Error 2.5 |
| KPL-716: LP Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -12.0 units on a scale | Standard Error 2 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -8.8 units on a scale | Standard Error 2.95 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -10.0 units on a scale | Standard Error 2.38 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -7.3 units on a scale | Standard Error 2.78 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -9.8 units on a scale | Standard Error 2.63 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -6.8 units on a scale | Standard Error 2.1 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -9.5 units on a scale | Standard Error 2.87 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -8.5 units on a scale | Standard Error 2.9 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -9.5 units on a scale | Standard Error 2.87 |
| KPL-716: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -10.0 units on a scale | Standard Error 2.38 |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -7.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -8.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -2.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -7.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -4.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -2.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -7.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -4.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -4.0 units on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -9.6 units on a scale | Standard Error 1.48 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -5.0 units on a scale | Standard Error 1.19 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -7.7 units on a scale | Standard Error 1.05 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -8.2 units on a scale | Standard Error 1.05 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -9.4 units on a scale | Standard Error 1.09 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -9.4 units on a scale | Standard Error 1.46 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -9.6 units on a scale | Standard Error 1.32 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -9.6 units on a scale | Standard Error 1.53 |
| KPL-716: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -8.9 units on a scale | Standard Error 1.57 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -4.1 units on a scale | Standard Error 1.81 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -6.5 units on a scale | Standard Error 1.78 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -6.3 units on a scale | Standard Error 1.71 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -6.0 units on a scale | Standard Error 1.81 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -5.0 units on a scale | Standard Error 1.75 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -5.0 units on a scale | Standard Error 1.79 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -3.6 units on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -7.0 units on a scale | Standard Error 1.65 |
| Placebo: PPs Cohort | Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -7.2 units on a scale | Standard Error 1.97 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked Over the last week, has your skin prevented you from working or studying? If answered yes, score=3; If no, a second question will be asked: Over the last week how much has your skin been a problem at work or studying? If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -6.5 score on a scale | Standard Error 1.04 |
| KPL-716: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -5.8 score on a scale | Standard Error 1.49 |
| KPL-716: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -6.5 score on a scale | Standard Error 1.04 |
| KPL-716: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -6.0 score on a scale | Standard Error 1.73 |
| KPL-716: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -7.3 score on a scale | Standard Error 1.55 |
| Placebo: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | 0.0 score on a scale | Standard Error 0 |
| KPL-716: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -4.4 score on a scale | Standard Error 2.02 |
| KPL-716: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -4.8 score on a scale | Standard Error 1.83 |
| KPL-716: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -3.6 score on a scale | Standard Error 1.37 |
| KPL-716: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -3.4 score on a scale | Standard Error 0.86 |
| KPL-716: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -4.3 score on a scale | Standard Error 1.53 |
| Placebo: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -8.0 score on a scale | Standard Error 1.96 |
| Placebo: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -8.3 score on a scale | Standard Error 2.01 |
| Placebo: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -8.7 score on a scale | Standard Error 2.28 |
| Placebo: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -8.3 score on a scale | Standard Error 2.01 |
| Placebo: CIP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -7.9 score on a scale | Standard Error 2.25 |
| KPL-716: LP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -10.0 score on a scale | Standard Error 1 |
| KPL-716: LP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -4.7 score on a scale | Standard Error 2.6 |
| KPL-716: LP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -7.0 score on a scale | Standard Error 2 |
| KPL-716: LP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -17.5 score on a scale | Standard Error 5.5 |
| KPL-716: LP Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -4.7 score on a scale | Standard Error 2.6 |
| KPL-716: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -3.0 score on a scale | Standard Error 4.55 |
| KPL-716: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -6.3 score on a scale | Standard Error 2.29 |
| KPL-716: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -6.5 score on a scale | Standard Error 2.18 |
| KPL-716: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -4.5 score on a scale | Standard Error 2.99 |
| KPL-716: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -3.0 score on a scale | Standard Error 4.55 |
| Placebo: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -5.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -12.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -12.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -8.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | 0.0 score on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -10.0 score on a scale | Standard Error 1.82 |
| KPL-716: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -10.7 score on a scale | Standard Error 1.69 |
| KPL-716: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -10.0 score on a scale | Standard Error 1.83 |
| KPL-716: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -9.9 score on a scale | Standard Error 2.01 |
| KPL-716: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -11.2 score on a scale | Standard Error 1.75 |
| Placebo: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 4 | -0.6 score on a scale | Standard Error 3.12 |
| Placebo: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 8 | -1.4 score on a scale | Standard Error 3.33 |
| Placebo: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 18 | -9.2 score on a scale | Standard Error 2.04 |
| Placebo: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 12 | -1.5 score on a scale | Standard Error 3.76 |
| Placebo: PPs Cohort | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Change at Week 16 | -9.5 score on a scale | Standard Error 2.46 |
Secondary
Change From Baseline in ItchyQoL Total Score Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -23.3 score on a scale | Standard Error 9.08 |
| KPL-716: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -29.3 score on a scale | Standard Error 9.68 |
| KPL-716: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -17.0 score on a scale | Standard Error 13.07 |
| KPL-716: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -33.3 score on a scale | Standard Error 11.46 |
| KPL-716: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -22.8 score on a scale | Standard Error 11.74 |
| Placebo: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | 0.0 score on a scale | Standard Error 0 |
| KPL-716: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -19.9 score on a scale | Standard Error 5.18 |
| KPL-716: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -22.0 score on a scale | Standard Error 5.96 |
| KPL-716: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -10.9 score on a scale | Standard Error 3.63 |
| KPL-716: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -25.1 score on a scale | Standard Error 7.18 |
| KPL-716: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -17.8 score on a scale | Standard Error 4.61 |
| Placebo: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -21.4 score on a scale | Standard Error 6.82 |
| Placebo: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -20.8 score on a scale | Standard Error 8.66 |
| Placebo: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -18.1 score on a scale | Standard Error 6.93 |
| Placebo: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -18.9 score on a scale | Standard Error 6.25 |
| Placebo: CIP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -19.2 score on a scale | Standard Error 5.78 |
| KPL-716: LP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -47.0 score on a scale | Standard Error 6 |
| KPL-716: LP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -27.3 score on a scale | Standard Error 15.32 |
| KPL-716: LP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -27.3 score on a scale | Standard Error 15.32 |
| KPL-716: LP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -50.0 score on a scale | Standard Error 3 |
| KPL-716: LP Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -64.5 score on a scale | Standard Error 14.5 |
| KPL-716: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -38.8 score on a scale | Standard Error 15.84 |
| KPL-716: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -41.5 score on a scale | Standard Error 11.99 |
| KPL-716: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -41.5 score on a scale | Standard Error 11.89 |
| KPL-716: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -46.8 score on a scale | Standard Error 8.62 |
| KPL-716: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -31.5 score on a scale | Standard Error 13.91 |
| Placebo: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -18.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -10.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | 0.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -18.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -15.0 score on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -35.5 score on a scale | Standard Error 6.54 |
| KPL-716: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -35.8 score on a scale | Standard Error 5.88 |
| KPL-716: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -32.9 score on a scale | Standard Error 6.4 |
| KPL-716: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -38.1 score on a scale | Standard Error 5.66 |
| KPL-716: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -29.0 score on a scale | Standard Error 5.61 |
| Placebo: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -31.8 score on a scale | Standard Error 8.46 |
| Placebo: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -16.9 score on a scale | Standard Error 7.04 |
| Placebo: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -29.2 score on a scale | Standard Error 8.15 |
| Placebo: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -23.1 score on a scale | Standard Error 7.31 |
| Placebo: PPs Cohort | Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -27.3 score on a scale | Standard Error 4.62 |
Secondary
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -5.2 units on a scale | Standard Error 1.82 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -4.2 units on a scale | Standard Error 2 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -3.9 units on a scale | Standard Error 2.07 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -4.5 units on a scale | Standard Error 1.91 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -4.3 units on a scale | Standard Error 1.67 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -1.7 units on a scale | Standard Error 0.98 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -5.1 units on a scale | Standard Error 1.78 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -3.3 units on a scale | Standard Error 1.52 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -3.5 units on a scale | Standard Error 2.19 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -4.1 units on a scale | Standard Error 2.11 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -2.8 units on a scale | Standard Error 1.43 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -4.8 units on a scale | Standard Error 1.86 |
| KPL-716: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -4.4 units on a scale | Standard Error 1.88 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -0.1 units on a scale | Standard Error 0.05 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | 0.0 units on a scale | Standard Error 0 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -4.7 units on a scale | Standard Error 1.05 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -5.0 units on a scale | Standard Error 1 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -4.2 units on a scale | Standard Error 1.07 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -3.0 units on a scale | Standard Error 0.96 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -3.2 units on a scale | Standard Error 1.09 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -3.7 units on a scale | Standard Error 0.94 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -4.5 units on a scale | Standard Error 1.01 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -1.3 units on a scale | Standard Error 0.79 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -4.2 units on a scale | Standard Error 1.22 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -4.5 units on a scale | Standard Error 1 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -4.4 units on a scale | Standard Error 1.03 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -4.2 units on a scale | Standard Error 1.07 |
| KPL-716: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -4.7 units on a scale | Standard Error 1.1 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -4.0 units on a scale | Standard Error 1.13 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -4.3 units on a scale | Standard Error 0.95 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -4.7 units on a scale | Standard Error 0.88 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -5.8 units on a scale | Standard Error 0.58 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -3.6 units on a scale | Standard Error 1.2 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -4.2 units on a scale | Standard Error 1.07 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -4.8 units on a scale | Standard Error 1.18 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -2.0 units on a scale | Standard Error 0.78 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -3.4 units on a scale | Standard Error 0.97 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -3.9 units on a scale | Standard Error 0.95 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -4.7 units on a scale | Standard Error 0.88 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -4.2 units on a scale | Standard Error 1.06 |
| Placebo: CIP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -2.6 units on a scale | Standard Error 0.62 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -3.0 units on a scale | Standard Error 1.86 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -5.3 units on a scale | Standard Error 1.1 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -3.3 units on a scale | Standard Error 1.85 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -5.6 units on a scale | Standard Error 2.4 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -5.6 units on a scale | Standard Error 0.85 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -2.0 units on a scale | Standard Error 1.36 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -0.4 units on a scale | Standard Error 0.26 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -5.1 units on a scale | Standard Error 1.3 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -5.6 units on a scale | Standard Error 0.85 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -0.4 units on a scale | Standard Error 0.19 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -3.1 units on a scale | Standard Error 1.85 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -3.3 units on a scale | Standard Error 1.85 |
| KPL-716: LP Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -2.8 units on a scale | Standard Error 1.88 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -5.2 units on a scale | Standard Error 1.85 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -5.7 units on a scale | Standard Error 1.67 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -6.3 units on a scale | Standard Error 1.37 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -5.9 units on a scale | Standard Error 1.57 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -4.4 units on a scale | Standard Error 1.8 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -6.1 units on a scale | Standard Error 1.45 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -6.0 units on a scale | Standard Error 1.42 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -4.0 units on a scale | Standard Error 1.61 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -7.0 units on a scale | Standard Error 0.74 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -6.2 units on a scale | Standard Error 1.5 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -6.6 units on a scale | Standard Error 1.12 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -6.4 units on a scale | Standard Error 1.31 |
| KPL-716: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -5.3 units on a scale | Standard Error 1.66 |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -3.5 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -0.7 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -3.5 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -2.2 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -0.9 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -1.4 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -1.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -2.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -3.7 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -1.4 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -0.8 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -1.8 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -2.2 units on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -5.6 units on a scale | Standard Error 0.71 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -1.3 units on a scale | Standard Error 0.29 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -2.2 units on a scale | Standard Error 0.55 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -3.4 units on a scale | Standard Error 0.55 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -4.3 units on a scale | Standard Error 0.51 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -5.2 units on a scale | Standard Error 0.54 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -5.3 units on a scale | Standard Error 0.57 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -5.8 units on a scale | Standard Error 0.61 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -5.9 units on a scale | Standard Error 0.66 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -4.3 units on a scale | Standard Error 0.54 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -5.8 units on a scale | Standard Error 0.75 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -5.6 units on a scale | Standard Error 0.79 |
| KPL-716: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -5.4 units on a scale | Standard Error 0.9 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 10 | -3.1 units on a scale | Standard Error 1.36 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 8 | -2.2 units on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 18 | -3.9 units on a scale | Standard Error 1.31 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 16 | -3.5 units on a scale | Standard Error 1.41 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 7 | -2.1 units on a scale | Standard Error 1.27 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 6 | -1.9 units on a scale | Standard Error 1.05 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 5 | -1.6 units on a scale | Standard Error 0.99 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 3 | -0.9 units on a scale | Standard Error 0.81 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 2 | -0.7 units on a scale | Standard Error 0.31 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 1 | -0.3 units on a scale | Standard Error 0.28 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 4 | -1.4 units on a scale | Standard Error 0.94 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 14 | -3.6 units on a scale | Standard Error 1.37 |
| Placebo: PPs Cohort | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Change at Week 12 | -3.8 units on a scale | Standard Error 1.26 |
Secondary
Change From Baseline in Sleep Loss VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -3.3 units on a scale | Standard Error 2.14 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -3.5 units on a scale | Standard Error 2.34 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -3.5 units on a scale | Standard Error 2.14 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -2.9 units on a scale | Standard Error 2.3 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -3.8 units on a scale | Standard Error 2.2 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -3.7 units on a scale | Standard Error 2.16 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -3.3 units on a scale | Standard Error 2.48 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -2.9 units on a scale | Standard Error 2.28 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -3.1 units on a scale | Standard Error 1.46 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -1.6 units on a scale | Standard Error 1.12 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -2.9 units on a scale | Standard Error 2.69 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -3.0 units on a scale | Standard Error 2.36 |
| KPL-716: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -2.4 units on a scale | Standard Error 1.86 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | 0.1 units on a scale | Standard Error 0.05 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | 0.1 units on a scale | Standard Error 0.05 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | 0.0 units on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo: CIU Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | 0.1 units on a scale | Standard Error 0.05 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -1.0 units on a scale | Standard Error 0.6 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 0.4 units on a scale | Standard Error 0.78 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -1.7 units on a scale | Standard Error 0.66 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -1.4 units on a scale | Standard Error 0.84 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -1.5 units on a scale | Standard Error 0.78 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -1.6 units on a scale | Standard Error 0.7 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -1.5 units on a scale | Standard Error 0.8 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -2.0 units on a scale | Standard Error 0.72 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -2.1 units on a scale | Standard Error 0.67 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -1.7 units on a scale | Standard Error 0.67 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -2.3 units on a scale | Standard Error 0.74 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -1.6 units on a scale | Standard Error 0.73 |
| KPL-716: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -2.1 units on a scale | Standard Error 0.67 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -3.9 units on a scale | Standard Error 0.96 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -4.3 units on a scale | Standard Error 0.88 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -3.1 units on a scale | Standard Error 1.03 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -2.1 units on a scale | Standard Error 1.17 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -5.4 units on a scale | Standard Error 0.8 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -3.8 units on a scale | Standard Error 0.91 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -3.9 units on a scale | Standard Error 0.79 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -3.6 units on a scale | Standard Error 0.83 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -3.4 units on a scale | Standard Error 0.86 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -4.0 units on a scale | Standard Error 1.02 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -4.9 units on a scale | Standard Error 0.72 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -2.6 units on a scale | Standard Error 0.71 |
| Placebo: CIP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -3.6 units on a scale | Standard Error 0.95 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -5.3 units on a scale | Standard Error 1.15 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -3.1 units on a scale | Standard Error 1.85 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -5.6 units on a scale | Standard Error 0.85 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -0.3 units on a scale | Standard Error 0.15 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -3.4 units on a scale | Standard Error 1.86 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -3.1 units on a scale | Standard Error 1.85 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -3.4 units on a scale | Standard Error 1.86 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -5.5 units on a scale | Standard Error 0.9 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -5.7 units on a scale | Standard Error 2.25 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -0.4 units on a scale | Standard Error 0.31 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -2.9 units on a scale | Standard Error 1.87 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -5.3 units on a scale | Standard Error 1.15 |
| KPL-716: LP Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -2.1 units on a scale | Standard Error 1.49 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -4.1 units on a scale | Standard Error 1.97 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -2.8 units on a scale | Standard Error 1.81 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -3.4 units on a scale | Standard Error 1.98 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -4.2 units on a scale | Standard Error 1.81 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -4.4 units on a scale | Standard Error 1.75 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -5.0 units on a scale | Standard Error 1.46 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -5.2 units on a scale | Standard Error 1.33 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -5.3 units on a scale | Standard Error 1.27 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -5.3 units on a scale | Standard Error 1.29 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -5.2 units on a scale | Standard Error 1.32 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -5.2 units on a scale | Standard Error 1.33 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -5.4 units on a scale | Standard Error 1.23 |
| KPL-716: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -5.6 units on a scale | Standard Error 1.11 |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -1.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -2.6 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -0.1 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -2.4 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -0.6 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -0.1 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -1.3 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -0.1 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 0.1 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -2.3 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -1.0 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -0.4 units on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | 0.0 units on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -3.0 units on a scale | Standard Error 0.62 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -5.4 units on a scale | Standard Error 0.63 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -4.9 units on a scale | Standard Error 0.58 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -4.6 units on a scale | Standard Error 0.56 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -5.2 units on a scale | Standard Error 0.68 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -4.0 units on a scale | Standard Error 0.59 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -3.7 units on a scale | Standard Error 0.62 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -5.3 units on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -2.1 units on a scale | Standard Error 0.48 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -4.9 units on a scale | Standard Error 0.9 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -5.1 units on a scale | Standard Error 0.75 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -1.2 units on a scale | Standard Error 0.25 |
| KPL-716: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -5.4 units on a scale | Standard Error 0.59 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -3.1 units on a scale | Standard Error 1.36 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -3.2 units on a scale | Standard Error 1.41 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -1.6 units on a scale | Standard Error 1.2 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -2.8 units on a scale | Standard Error 1.51 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -0.1 units on a scale | Standard Error 0.35 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -1.8 units on a scale | Standard Error 1.34 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -3.3 units on a scale | Standard Error 1.42 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -1.0 units on a scale | Standard Error 0.75 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -3.0 units on a scale | Standard Error 1.49 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -0.3 units on a scale | Standard Error 1.3 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -0.4 units on a scale | Standard Error 0.58 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -2.1 units on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -1.2 units on a scale | Standard Error 1.14 |
Secondary
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 2 | -0.9 score on a scale | Standard Error 0.15 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 3 | -1.0 score on a scale | Standard Error 0.36 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 4 | -1.2 score on a scale | Standard Error 0.3 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 15 | -1.1 score on a scale | Standard Error 0.38 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 16 | -0.9 score on a scale | Standard Error 0.39 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 1 | -0.7 score on a scale | Standard Error 0.13 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 5 | -1.2 score on a scale | Standard Error 0.28 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 6 | -1.4 score on a scale | Standard Error 0.22 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 7 | -1.1 score on a scale | Standard Error 0.3 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 8 | -0.8 score on a scale | Standard Error 0.4 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 9 | -1.2 score on a scale | Standard Error 0.27 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 10 | -1.1 score on a scale | Standard Error 0.35 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 11 | -1.0 score on a scale | Standard Error 0.39 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 12 | -1.0 score on a scale | Standard Error 0.39 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 13 | -0.7 score on a scale | Standard Error 0.44 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 14 | -0.9 score on a scale | Standard Error 0.41 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 17 | -1.1 score on a scale | Standard Error 0.35 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 18 | -1.3 score on a scale | Standard Error 0.24 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 12 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 2 | -0.2 score on a scale | Standard Error 0.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 8 | -0.1 score on a scale | Standard Error 0.14 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 3 | -0.4 score on a scale | Standard Error 0.36 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 18 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 4 | -0.2 score on a scale | Standard Error 0.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 14 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 9 | -0.1 score on a scale | Standard Error 0.14 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 15 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 13 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 10 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 1 | 0.3 score on a scale | Standard Error 0.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 17 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 5 | -0.2 score on a scale | Standard Error 0.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 11 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 6 | -0.1 score on a scale | Standard Error 0.14 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 16 | -0.6 score on a scale | Standard Error 0.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 7 | -0.4 score on a scale | Standard Error 0.43 |
Secondary
Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -5.0 score on a scale | Standard Error 1.57 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -4.2 score on a scale | Standard Error 1.21 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -5.0 score on a scale | Standard Error 1.45 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -4.1 score on a scale | Standard Error 1.9 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -4.5 score on a scale | Standard Error 1.56 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -4.4 score on a scale | Standard Error 1.64 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -4.4 score on a scale | Standard Error 1.77 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -2.1 score on a scale | Standard Error 0.67 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -3.3 score on a scale | Standard Error 0.78 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -3.6 score on a scale | Standard Error 1.92 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -4.5 score on a scale | Standard Error 1.35 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -4.4 score on a scale | Standard Error 1.46 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -4.7 score on a scale | Standard Error 1.78 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -3.8 score on a scale | Standard Error 1.66 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -4.2 score on a scale | Standard Error 1.91 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -4.7 score on a scale | Standard Error 1.73 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -4.4 score on a scale | Standard Error 1.79 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -4.1 score on a scale | Standard Error 1.86 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -0.2 score on a scale | Standard Error 0.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -0.3 score on a scale | Standard Error 0.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -0.4 score on a scale | Standard Error 0.43 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -0.3 score on a scale | Standard Error 0.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -0.4 score on a scale | Standard Error 0.43 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | 0.7 score on a scale | Standard Error 0.71 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -2.8 score on a scale | Standard Error 0.72 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -2.6 score on a scale | Standard Error 0.61 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -3.0 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -3.0 score on a scale | Standard Error 0.76 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -2.8 score on a scale | Standard Error 0.68 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -2.6 score on a scale | Standard Error 0.76 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -3.2 score on a scale | Standard Error 0.64 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -2.0 score on a scale | Standard Error 0.52 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -2.6 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -2.7 score on a scale | Standard Error 0.64 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -2.9 score on a scale | Standard Error 0.69 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -3.0 score on a scale | Standard Error 0.69 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -2.7 score on a scale | Standard Error 0.72 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -2.8 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -2.5 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -0.6 score on a scale | Standard Error 0.44 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -2.6 score on a scale | Standard Error 0.59 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -2.5 score on a scale | Standard Error 0.73 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -3.0 score on a scale | Standard Error 0.71 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -1.7 score on a scale | Standard Error 0.4 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -3.1 score on a scale | Standard Error 0.57 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -2.9 score on a scale | Standard Error 0.7 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -2.9 score on a scale | Standard Error 0.82 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -3.8 score on a scale | Standard Error 0.71 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -3.7 score on a scale | Standard Error 0.75 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -2.9 score on a scale | Standard Error 0.81 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -3.7 score on a scale | Standard Error 0.65 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -4.5 score on a scale | Standard Error 0.55 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -4.6 score on a scale | Standard Error 0.69 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -4.1 score on a scale | Standard Error 0.71 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -4.3 score on a scale | Standard Error 0.73 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -4.3 score on a scale | Standard Error 0.78 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -4.1 score on a scale | Standard Error 0.73 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -3.8 score on a scale | Standard Error 0.91 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -3.5 score on a scale | Standard Error 0.85 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -3.6 score on a scale | Standard Error 0.92 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -0.3 score on a scale | Standard Error 0.08 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -0.9 score on a scale | Standard Error 0.3 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -2.9 score on a scale | Standard Error 1.64 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -1.6 score on a scale | Standard Error 0.87 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -5.7 score on a scale | Standard Error 0.43 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -3.6 score on a scale | Standard Error 1.65 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -3.1 score on a scale | Standard Error 1.61 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -3.6 score on a scale | Standard Error 1.65 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -5.6 score on a scale | Standard Error 0.43 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -2.5 score on a scale | Standard Error 1.57 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -5.6 score on a scale | Standard Error 1.69 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -6.2 score on a scale | Standard Error 1.32 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -5.6 score on a scale | Standard Error 1.76 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -5.4 score on a scale | Standard Error 1.94 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -5.2 score on a scale | Standard Error 1.95 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -3.0 score on a scale | Standard Error 1.31 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -5.7 score on a scale | Standard Error 1.61 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -5.4 score on a scale | Standard Error 1.88 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -5.9 score on a scale | Standard Error 1.5 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -4.8 score on a scale | Standard Error 1.91 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -5.9 score on a scale | Standard Error 1.53 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -5.5 score on a scale | Standard Error 1.82 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -5.8 score on a scale | Standard Error 1.58 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -4.6 score on a scale | Standard Error 2.1 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -6.2 score on a scale | Standard Error 1.32 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -6.0 score on a scale | Standard Error 1.45 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -4.3 score on a scale | Standard Error 1.96 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -6.0 score on a scale | Standard Error 1.43 |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -1.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -1.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -1.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -3.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -1.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -2.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -2.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -2.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -3.1 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -3.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -1.3 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -2.1 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -3.3 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -2.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -1.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -2.1 score on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -5.3 score on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -1.3 score on a scale | Standard Error 0.26 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -5.2 score on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -5.0 score on a scale | Standard Error 0.8 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -4.9 score on a scale | Standard Error 0.81 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -4.6 score on a scale | Standard Error 0.97 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -2.4 score on a scale | Standard Error 0.56 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -5.2 score on a scale | Standard Error 0.77 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -5.1 score on a scale | Standard Error 0.78 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -4.4 score on a scale | Standard Error 0.69 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | -0.7 score on a scale | Standard Error 0.16 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -4.8 score on a scale | Standard Error 0.72 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -5.0 score on a scale | Standard Error 0.77 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -5.0 score on a scale | Standard Error 0.83 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -3.1 score on a scale | Standard Error 0.55 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -4.1 score on a scale | Standard Error 0.72 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -4.6 score on a scale | Standard Error 0.98 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -4.9 score on a scale | Standard Error 0.78 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 2 | -0.6 score on a scale | Standard Error 0.35 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 17 | -3.0 score on a scale | Standard Error 1.37 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 9 | -2.4 score on a scale | Standard Error 1.27 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 5 | -1.5 score on a scale | Standard Error 0.89 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 10 | -2.4 score on a scale | Standard Error 1.21 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 11 | -2.4 score on a scale | Standard Error 1.2 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 4 | -1.0 score on a scale | Standard Error 0.7 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 12 | -2.5 score on a scale | Standard Error 1.17 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 18 | -3.0 score on a scale | Standard Error 1.36 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 13 | -2.5 score on a scale | Standard Error 1.18 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 3 | -0.8 score on a scale | Standard Error 0.42 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 14 | -2.6 score on a scale | Standard Error 1.2 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 6 | -1.4 score on a scale | Standard Error 0.9 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 15 | -2.8 score on a scale | Standard Error 1.35 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 16 | -2.7 score on a scale | Standard Error 1.32 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 1 | 0.0 score on a scale | Standard Error 0.24 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 7 | -1.8 score on a scale | Standard Error 1.08 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time | Change at Week 8 | -2.1 score on a scale | Standard Error 1.21 |
Secondary
Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -2.8 score on a scale | Standard Error 2.35 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -2.6 score on a scale | Standard Error 2.31 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -2.6 score on a scale | Standard Error 2.45 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -3.5 score on a scale | Standard Error 2.03 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -3.0 score on a scale | Standard Error 2.23 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -2.0 score on a scale | Standard Error 1.63 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -2.6 score on a scale | Standard Error 2.31 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -2.5 score on a scale | Standard Error 2.43 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -2.4 score on a scale | Standard Error 2.11 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -1.9 score on a scale | Standard Error 1.86 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.8 score on a scale | Standard Error 1.32 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -2.7 score on a scale | Standard Error 2.04 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -2.5 score on a scale | Standard Error 1.93 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.6 score on a scale | Standard Error 2.12 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -3.3 score on a scale | Standard Error 2.12 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -2.5 score on a scale | Standard Error 2.23 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -2.9 score on a scale | Standard Error 2.12 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -2.5 score on a scale | Standard Error 2.38 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | 0.7 score on a scale | Standard Error 0.71 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -0.4 score on a scale | Standard Error 0.43 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | 0.0 score on a scale | Standard Error 0 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -0.2 score on a scale | Standard Error 0.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -0.4 score on a scale | Standard Error 0.43 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.3 score on a scale | Standard Error 0.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -0.3 score on a scale | Standard Error 0.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -0.5 score on a scale | Standard Error 0.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -0.5 score on a scale | Standard Error 0.5 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -1.6 score on a scale | Standard Error 0.8 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.2 score on a scale | Standard Error 0.33 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -1.7 score on a scale | Standard Error 0.56 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -1.9 score on a scale | Standard Error 0.54 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.0 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -2.3 score on a scale | Standard Error 0.68 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -2.4 score on a scale | Standard Error 0.69 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -2.4 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -2.5 score on a scale | Standard Error 0.67 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -2.3 score on a scale | Standard Error 0.69 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -1.9 score on a scale | Standard Error 0.65 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -2.0 score on a scale | Standard Error 0.72 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -1.9 score on a scale | Standard Error 0.72 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -2.0 score on a scale | Standard Error 0.62 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -2.1 score on a scale | Standard Error 0.62 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -2.5 score on a scale | Standard Error 0.7 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -2.3 score on a scale | Standard Error 0.66 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -2.3 score on a scale | Standard Error 0.74 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -4.4 score on a scale | Standard Error 0.83 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -2.7 score on a scale | Standard Error 0.62 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -4.9 score on a scale | Standard Error 0.77 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -2.8 score on a scale | Standard Error 0.73 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -3.7 score on a scale | Standard Error 0.98 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -3.6 score on a scale | Standard Error 1.01 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -3.6 score on a scale | Standard Error 0.89 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -3.7 score on a scale | Standard Error 0.64 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -4.1 score on a scale | Standard Error 0.89 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -2.7 score on a scale | Standard Error 0.6 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -3.6 score on a scale | Standard Error 0.79 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -4.1 score on a scale | Standard Error 0.78 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -4.3 score on a scale | Standard Error 0.94 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.7 score on a scale | Standard Error 0.93 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -1.6 score on a scale | Standard Error 0.43 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -4.9 score on a scale | Standard Error 0.71 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -4.6 score on a scale | Standard Error 0.85 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -3.6 score on a scale | Standard Error 1 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -5.6 score on a scale | Standard Error 0.43 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.3 score on a scale | Standard Error 1.67 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -1.5 score on a scale | Standard Error 1.02 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.2 score on a scale | Standard Error 0.17 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -3.0 score on a scale | Standard Error 1.73 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -2.8 score on a scale | Standard Error 1.75 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -3.4 score on a scale | Standard Error 1.78 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -5.6 score on a scale | Standard Error 0.36 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -3.4 score on a scale | Standard Error 1.78 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -5.7 score on a scale | Standard Error 0.43 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -5.1 score on a scale | Standard Error 0.86 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -0.7 score on a scale | Standard Error 0.41 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -5.7 score on a scale | Standard Error 1.21 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -5.3 score on a scale | Standard Error 1.43 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -5.6 score on a scale | Standard Error 1.24 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -4.4 score on a scale | Standard Error 1.78 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -5.6 score on a scale | Standard Error 1.28 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -5.7 score on a scale | Standard Error 1.21 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -4.2 score on a scale | Standard Error 1.98 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -5.7 score on a scale | Standard Error 1.21 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -5.6 score on a scale | Standard Error 1.24 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -3.7 score on a scale | Standard Error 1.75 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -5.5 score on a scale | Standard Error 1.3 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -5.7 score on a scale | Standard Error 1.21 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -5.7 score on a scale | Standard Error 1.22 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -5.8 score on a scale | Standard Error 1.19 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -2.6 score on a scale | Standard Error 1.26 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -5.7 score on a scale | Standard Error 1.21 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -4.4 score on a scale | Standard Error 1.61 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -5.2 score on a scale | Standard Error 1.53 |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -2.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -2.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -1.7 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -0.7 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -3.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -1.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -3.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -2.1 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -1.3 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -1.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -2.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -1.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -1.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -2.7 score on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -4.6 score on a scale | Standard Error 0.95 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -1.1 score on a scale | Standard Error 0.3 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -5.2 score on a scale | Standard Error 0.74 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.6 score on a scale | Standard Error 0.2 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -4.7 score on a scale | Standard Error 0.72 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -4.8 score on a scale | Standard Error 0.8 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -4.6 score on a scale | Standard Error 0.96 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -5.0 score on a scale | Standard Error 0.8 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.8 score on a scale | Standard Error 0.59 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -5.0 score on a scale | Standard Error 0.81 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -3.8 score on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -2.0 score on a scale | Standard Error 0.52 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -5.0 score on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -4.2 score on a scale | Standard Error 0.71 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -4.9 score on a scale | Standard Error 0.8 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -3.5 score on a scale | Standard Error 0.75 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -5.0 score on a scale | Standard Error 0.77 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -4.9 score on a scale | Standard Error 0.78 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -5.0 score on a scale | Standard Error 0.81 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -2.0 score on a scale | Standard Error 1.25 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -2.5 score on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -2.5 score on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -2.3 score on a scale | Standard Error 1.27 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -0.3 score on a scale | Standard Error 0.19 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -2.0 score on a scale | Standard Error 1.24 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -0.9 score on a scale | Standard Error 0.64 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -2.2 score on a scale | Standard Error 1.25 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -1.9 score on a scale | Standard Error 1.29 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -1.1 score on a scale | Standard Error 0.95 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -0.5 score on a scale | Standard Error 0.42 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -1.2 score on a scale | Standard Error 0.91 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -2.1 score on a scale | Standard Error 1.24 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -1.5 score on a scale | Standard Error 1.1 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -2.0 score on a scale | Standard Error 1.35 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -0.4 score on a scale | Standard Error 0.29 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -1.8 score on a scale | Standard Error 1.23 |
Secondary
Change From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -4.5 score on a scale | Standard Error 1.81 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -4.5 score on a scale | Standard Error 1.72 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -3.0 score on a scale | Standard Error 0.79 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -4.6 score on a scale | Standard Error 1.72 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -4.1 score on a scale | Standard Error 1.73 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -4.1 score on a scale | Standard Error 1.74 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -4.1 score on a scale | Standard Error 1.74 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -3.8 score on a scale | Standard Error 1.75 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -4.1 score on a scale | Standard Error 1.69 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -4.4 score on a scale | Standard Error 1.75 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -4.4 score on a scale | Standard Error 1.67 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -3.8 score on a scale | Standard Error 1.25 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -3.9 score on a scale | Standard Error 1.85 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -4.1 score on a scale | Standard Error 1.84 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -4.4 score on a scale | Standard Error 1.83 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -3.9 score on a scale | Standard Error 1.59 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -4.4 score on a scale | Standard Error 1.68 |
| KPL-716: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -1.9 score on a scale | Standard Error 0.59 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -1.6 score on a scale | Standard Error 1.64 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -2.6 score on a scale | Standard Error 2.64 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -1.8 score on a scale | Standard Error 1.79 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -1.5 score on a scale | Standard Error 1.5 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -0.9 score on a scale | Standard Error 0.86 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -1.6 score on a scale | Standard Error 1.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -1.3 score on a scale | Standard Error 1.29 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -2.2 score on a scale | Standard Error 2.21 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -1.6 score on a scale | Standard Error 1.57 |
| Placebo: CIU Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -1.6 score on a scale | Standard Error 1.64 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -1.6 score on a scale | Standard Error 0.55 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -3.5 score on a scale | Standard Error 0.61 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -3.0 score on a scale | Standard Error 0.6 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -4.4 score on a scale | Standard Error 0.86 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -4.6 score on a scale | Standard Error 0.88 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -4.4 score on a scale | Standard Error 0.83 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -4.4 score on a scale | Standard Error 0.9 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -4.3 score on a scale | Standard Error 0.75 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -4.5 score on a scale | Standard Error 0.8 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -4.4 score on a scale | Standard Error 0.77 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -4.2 score on a scale | Standard Error 0.85 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -4.3 score on a scale | Standard Error 0.87 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -4.2 score on a scale | Standard Error 0.74 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -4.5 score on a scale | Standard Error 0.89 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -4.3 score on a scale | Standard Error 0.87 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -4.1 score on a scale | Standard Error 0.73 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -4.3 score on a scale | Standard Error 0.97 |
| KPL-716: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -3.5 score on a scale | Standard Error 0.64 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -3.4 score on a scale | Standard Error 0.97 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -2.4 score on a scale | Standard Error 0.72 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -4.3 score on a scale | Standard Error 0.76 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -3.8 score on a scale | Standard Error 0.91 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -3.7 score on a scale | Standard Error 0.81 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -3.0 score on a scale | Standard Error 0.85 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -4.1 score on a scale | Standard Error 0.92 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -3.7 score on a scale | Standard Error 0.94 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -2.9 score on a scale | Standard Error 0.63 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -3.4 score on a scale | Standard Error 1.06 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -4.2 score on a scale | Standard Error 0.86 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -1.4 score on a scale | Standard Error 0.45 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -3.8 score on a scale | Standard Error 0.76 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -4.7 score on a scale | Standard Error 0.64 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -3.1 score on a scale | Standard Error 0.88 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -3.5 score on a scale | Standard Error 0.96 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -3.7 score on a scale | Standard Error 0.92 |
| Placebo: CIP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -4.9 score on a scale | Standard Error 0.75 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -5.0 score on a scale | Standard Error 1 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -5.3 score on a scale | Standard Error 0.71 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -5.5 score on a scale | Standard Error 0.5 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -5.5 score on a scale | Standard Error 0.5 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -5.5 score on a scale | Standard Error 0.5 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -5.5 score on a scale | Standard Error 0.5 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -5.5 score on a scale | Standard Error 0.5 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -5.6 score on a scale | Standard Error 0.57 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -0.2 score on a scale | Standard Error 0.13 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -0.5 score on a scale | Standard Error 0.58 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -1.2 score on a scale | Standard Error 0.99 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -2.3 score on a scale | Standard Error 1.78 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -2.5 score on a scale | Standard Error 1.91 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -2.7 score on a scale | Standard Error 1.9 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -3.1 score on a scale | Standard Error 1.94 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -5.0 score on a scale | Standard Error 1 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -5.0 score on a scale | Standard Error 1 |
| KPL-716: LP Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -3.1 score on a scale | Standard Error 1.94 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -6.0 score on a scale | Standard Error 1.76 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -6.6 score on a scale | Standard Error 1.32 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -6.4 score on a scale | Standard Error 1.42 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -6.3 score on a scale | Standard Error 1.42 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -6.0 score on a scale | Standard Error 1.61 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -5.0 score on a scale | Standard Error 1.48 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -3.0 score on a scale | Standard Error 1.23 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -6.8 score on a scale | Standard Error 1.11 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -4.0 score on a scale | Standard Error 1.64 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -6.3 score on a scale | Standard Error 1.46 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -5.4 score on a scale | Standard Error 1.58 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -4.6 score on a scale | Standard Error 1.73 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -6.3 score on a scale | Standard Error 1.48 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -6.6 score on a scale | Standard Error 1.25 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -6.5 score on a scale | Standard Error 1.27 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -5.8 score on a scale | Standard Error 1.58 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -6.9 score on a scale | Standard Error 1.01 |
| KPL-716: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -6.8 score on a scale | Standard Error 1.23 |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -3.3 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -2.3 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -0.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -2.7 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -1.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -2.9 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -2.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -2.7 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -2.6 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -2.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -3.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -1.0 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -1.4 score on a scale | — |
| Placebo: LSC Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -1.6 score on a scale | — |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -5.6 score on a scale | Standard Error 0.81 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -2.6 score on a scale | Standard Error 0.39 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -5.0 score on a scale | Standard Error 1.01 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -5.6 score on a scale | Standard Error 0.75 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -3.4 score on a scale | Standard Error 0.48 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -5.0 score on a scale | Standard Error 0.99 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -4.4 score on a scale | Standard Error 0.65 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -5.3 score on a scale | Standard Error 0.86 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -4.7 score on a scale | Standard Error 0.65 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -5.1 score on a scale | Standard Error 0.69 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -5.5 score on a scale | Standard Error 0.83 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -5.6 score on a scale | Standard Error 0.66 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -5.3 score on a scale | Standard Error 0.8 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -5.4 score on a scale | Standard Error 0.86 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -5.7 score on a scale | Standard Error 0.7 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -5.4 score on a scale | Standard Error 0.78 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -1.5 score on a scale | Standard Error 0.27 |
| KPL-716: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -0.7 score on a scale | Standard Error 0.17 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -2.7 score on a scale | Standard Error 1.39 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -2.3 score on a scale | Standard Error 1.21 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -0.7 score on a scale | Standard Error 0.26 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -2.5 score on a scale | Standard Error 1.21 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -1.6 score on a scale | Standard Error 0.81 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -2.6 score on a scale | Standard Error 1.35 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -2.2 score on a scale | Standard Error 1.22 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -0.9 score on a scale | Standard Error 0.33 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -1.5 score on a scale | Standard Error 0.88 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -0.2 score on a scale | Standard Error 0.16 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -2.2 score on a scale | Standard Error 1.23 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -2.6 score on a scale | Standard Error 1.33 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -2.5 score on a scale | Standard Error 1.07 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -2.3 score on a scale | Standard Error 1.22 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -1.9 score on a scale | Standard Error 0.91 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -2.2 score on a scale | Standard Error 1.21 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -1.2 score on a scale | Standard Error 0.63 |
| Placebo: PPs Cohort | Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -2.7 score on a scale | Standard Error 1.38 |
Secondary
Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 25.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 75.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 25.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 75.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 25.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 25.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 50.0 percentage of participants |
| KPL-716: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 50.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 0.0 percentage of participants |
| Placebo: CIU Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 50.0 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 57.1 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 57.1 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 50.0 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 50.0 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 21.4 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 28.6 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 42.9 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 42.9 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 58.3 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 50.0 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 57.1 percentage of participants |
| KPL-716: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 50.0 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 33.3 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 77.8 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 33.3 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 66.7 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 55.6 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 66.7 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 55.6 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 11.1 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 55.6 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 55.6 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 77.8 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 44.4 percentage of participants |
| Placebo: CIP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 66.7 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 33.3 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 66.7 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 66.7 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 0.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 0.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 33.3 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 33.3 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 100.0 percentage of participants |
| KPL-716: LP Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 100.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 50.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 50.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 50.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 75.0 percentage of participants |
| KPL-716: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 100.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 0.0 percentage of participants |
| Placebo: LSC Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 0.0 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 64.3 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 64.3 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 57.1 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 50.0 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 42.9 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 21.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 71.4 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 78.6 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 0.0 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 64.3 percentage of participants |
| KPL-716: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 78.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 0.0 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 0.0 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 0.0 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | 14.3 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 28.6 percentage of participants |
| Placebo: PPs Cohort | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 14.3 percentage of participants |
Secondary
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -42.7 percent change | Standard Error 9.4 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -37.7 percent change | Standard Error 8.29 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -41.4 percent change | Standard Error 10.22 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -33.3 percent change | Standard Error 9.21 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -17.9 percent change | Standard Error 14.08 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -31.3 percent change | Standard Error 10.41 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -31.3 percent change | Standard Error 13.4 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -40.1 percent change | Standard Error 8.46 |
| KPL-716: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -37.7 percent change | Standard Error 10.85 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | 2.4 percent change | Standard Error 13.31 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | 1.6 percent change | Standard Error 14.75 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | 0.0 percent change | Standard Error 18.98 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | 2.3 percent change | Standard Error 14.48 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -2.2 percent change | Standard Error 15.36 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -1.1 percent change | Standard Error 19.95 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -0.8 percent change | Standard Error 13.05 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | 1.7 percent change | Standard Error 11.74 |
| Placebo: CIU Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -4.5 percent change | Standard Error 11.98 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -24.2 percent change | Standard Error 6 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -36.2 percent change | Standard Error 5.83 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -24.1 percent change | Standard Error 7.03 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -35.9 percent change | Standard Error 6.66 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -32.9 percent change | Standard Error 8.83 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -34.4 percent change | Standard Error 6.3 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -33.5 percent change | Standard Error 6.64 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -35.2 percent change | Standard Error 6.47 |
| KPL-716: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -37.0 percent change | Standard Error 8.29 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -37.2 percent change | Standard Error 7.85 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -31.6 percent change | Standard Error 8.31 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -43.1 percent change | Standard Error 7.48 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -34.4 percent change | Standard Error 7.66 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -25.0 percent change | Standard Error 10.19 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -27.8 percent change | Standard Error 9.57 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -29.2 percent change | Standard Error 8.77 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -20.6 percent change | Standard Error 7.48 |
| Placebo: CIP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -33.3 percent change | Standard Error 6.74 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -55.4 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -38.8 percent change | Standard Error 17.46 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -11.8 percent change | Standard Error 8.46 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -38.8 percent change | Standard Error 17.46 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -58.2 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -64.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -58.2 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -58.2 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -35.1 percent change | Standard Error 12.38 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -58.1 percent change | Standard Error 0.83 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -44.0 percent change | Standard Error 3.43 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -62.1 percent change | Standard Error 3.76 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -56.5 percent change | Standard Error 1.49 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -49.1 percent change | Standard Error 2.09 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -63.6 percent change | Standard Error 3.33 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -63.6 percent change | Standard Error 3.33 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -62.1 percent change | Standard Error 3.76 |
| KPL-716: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -62.8 percent change | Standard Error 3.53 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | 18.5 percent change | Standard Error 7.81 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -3.4 percent change | Standard Error 8.28 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | 23.0 percent change | Standard Error 4.9 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | 9.1 percent change | Standard Error 3.49 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | 10.1 percent change | Standard Error 1.95 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | 6.6 percent change | Standard Error 8.82 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | 20.2 percent change | Standard Error 8.82 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | 8.4 percent change | Standard Error 8.04 |
| Placebo: LSC Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | 18.5 percent change | Standard Error 7.81 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -50.2 percent change | Standard Error 5.86 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -43.3 percent change | Standard Error 5.67 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -49.1 percent change | Standard Error 5.49 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -40.3 percent change | Standard Error 5.55 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -49.1 percent change | Standard Error 6.55 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -25.4 percent change | Standard Error 5.38 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -46.6 percent change | Standard Error 7.43 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -49.9 percent change | Standard Error 7.08 |
| KPL-716: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -49.7 percent change | Standard Error 7.04 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 16 | -36.8 percent change | Standard Error 10.88 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 10 | -29.6 percent change | Standard Error 10.06 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 8 | -25.7 percent change | Standard Error 7.77 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 6 | -25.9 percent change | Standard Error 8.02 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 14 | -33.1 percent change | Standard Error 10.81 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 4 | -20.8 percent change | Standard Error 7.85 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 2 | -18.8 percent change | Standard Error 7.61 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 12 | -31.4 percent change | Standard Error 9 |
| Placebo: PPs Cohort | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Change at Week 18 | -35.5 percent change | Standard Error 11.41 |
Comparison: Change at Week 2p-value: 0.499580% CI: [-166.52, 84.74]ANCOVA
Comparison: Change at Week 2p-value: 0.707180% CI: [-16.37, 9.06]ANCOVA
Comparison: Change at Week 2p-value: 0.030580% CI: [-70.18, -34.77]ANCOVA
Comparison: Change at Week 2p-value: 0.488480% CI: [-19.01, 5.81]ANCOVA
Comparison: Change at Week 4p-value: 0.288580% CI: [-104.93, 14.35]ANCOVA
Comparison: Change at Week 4p-value: 0.650580% CI: [-9.73, 20.06]ANCOVA
Comparison: Change at Week 4p-value: 0.006280% CI: [-82.91, -61.34]ANCOVA
Comparison: Change at Week 4p-value: 0.057180% CI: [-32.34, -6.76]ANCOVA
Comparison: Change at Week 6
Comparison: Change at Week 6p-value: 0.692780% CI: [-18.38, 9.84]ANCOVA
Comparison: Change at Week 6p-value: 0.003880% CI: [-73.33, -57.94]ANCOVA
Comparison: Change at Week 6p-value: 0.09480% CI: [-30.43, -4.3]ANCOVA
Comparison: Change at Week 8p-value: 0.169480% CI: [-133.1, -11.65]ANCOVA
Comparison: Change at Week 8p-value: 0.781180% CI: [-10.5, 16.18]ANCOVA
Comparison: Change at Week 8p-value: 0.001180% CI: [-72.51, -63.91]ANCOVA
Comparison: Change at Week 8p-value: 0.024580% CI: [-36.02, -10.7]ANCOVA
Comparison: Change at Week 10p-value: 0.060380% CI: [-79.88, -43.74]ANCOVA
Comparison: Change at Week 10p-value: 0.436580% CI: [-5.29, 21.04]ANCOVA
Comparison: Change at Week 10p-value: 0.021880% CI: [-88.11, -49.26]ANCOVA
Comparison: Change at Week 10p-value: 0.123880% CI: [-35.65, -3.45]ANCOVA
Comparison: Change at Week 12p-value: 0.143780% CI: [-98.88, -10.72]ANCOVA
Comparison: Change at Week 12p-value: 0.927980% CI: [-12.56, 14.43]ANCOVA
Comparison: Change at Week 12p-value: 0.025480% CI: [-77.69, -41.24]ANCOVA
Comparison: Change at Week 12p-value: 0.099480% CI: [-33.23, -4.43]ANCOVA
Comparison: Change at Week 14p-value: 0.365680% CI: [-119.9, 28.54]ANCOVA
Comparison: Change at Week 14p-value: 0.746580% CI: [-14.79, 8.94]ANCOVA
Comparison: Change at Week 14p-value: 0.015380% CI: [-101.75, -62.9]ANCOVA
Comparison: Change at Week 14p-value: 0.218480% CI: [-33.88, 0.72]ANCOVA
Comparison: Change at Week 16p-value: 0.772680% CI: [-50.37, 34.07]ANCOVA
Comparison: Change at Week 16p-value: 0.47680% CI: [-26.07, 7.63]ANCOVA
Comparison: Change at Week 16p-value: 0.012180% CI: [-99.26, -64.87]ANCOVA
Comparison: Change at Week 16p-value: 0.332980% CI: [-30.43, 4.4]ANCOVA
Comparison: Change at Week 18p-value: 0.956480% CI: [-48.31, 44.92]ANCOVA
Comparison: Change at Week 18p-value: 0.566180% CI: [-25.84, 10.06]ANCOVA
Comparison: Change at Week 18p-value: 0.012180% CI: [-99.26, -64.87]ANCOVA
Comparison: Change at Week 18p-value: 0.427580% CI: [-29.4, 7.13]ANCOVA
Secondary
Percent Change From Baseline in DLQI Total Score Over Time
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked Over the last week, has your skin prevented you from working or studying? If answered yes, score=3; If no, a second question will be asked: Over the last week how much has your skin been a problem at work or studying? If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -54.5 percent change | Standard Error 12.95 |
| KPL-716: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -52.5 percent change | Standard Error 18.16 |
| KPL-716: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -51.0 percent change | Standard Error 17.71 |
| KPL-716: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -60.5 percent change | Standard Error 15.08 |
| KPL-716: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -54.5 percent change | Standard Error 12.95 |
| Placebo: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -2.4 percent change | Standard Error 18.53 |
| Placebo: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -3.7 percent change | Standard Error 25.35 |
| Placebo: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -3.4 percent change | Standard Error 25.99 |
| Placebo: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -2.4 percent change | Standard Error 18.53 |
| Placebo: CIU Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -2.5 percent change | Standard Error 21.57 |
| KPL-716: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -51.0 percent change | Standard Error 11.94 |
| KPL-716: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -48.1 percent change | Standard Error 14.36 |
| KPL-716: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -32.8 percent change | Standard Error 8.77 |
| KPL-716: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -44.0 percent change | Standard Error 12.37 |
| KPL-716: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -41.1 percent change | Standard Error 13.32 |
| Placebo: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -61.3 percent change | Standard Error 14.29 |
| Placebo: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -56.0 percent change | Standard Error 16.63 |
| Placebo: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -54.0 percent change | Standard Error 13.79 |
| Placebo: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -52.4 percent change | Standard Error 10.95 |
| Placebo: CIP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -55.7 percent change | Standard Error 16.59 |
| KPL-716: LP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -36.4 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -24.2 percent change | Standard Error 17.01 |
| KPL-716: LP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -24.2 percent change | Standard Error 17.01 |
| KPL-716: LP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -61.4 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -89.7 percent change | Standard Error 0 |
| KPL-716: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -32.5 percent change | Standard Error 64.55 |
| KPL-716: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -32.5 percent change | Standard Error 64.55 |
| KPL-716: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -71.9 percent change | Standard Error 23.07 |
| KPL-716: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -75.0 percent change | Standard Error 19.53 |
| KPL-716: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -53.5 percent change | Standard Error 33.55 |
| Placebo: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -85.7 percent change | Standard Error 182.21 |
| Placebo: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -85.7 percent change | Standard Error 182.21 |
| Placebo: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | 6.1 percent change | Standard Error 94.72 |
| Placebo: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -41.5 percent change | Standard Error 65.13 |
| Placebo: LSC Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -52.4 percent change | Standard Error 55.14 |
| KPL-716: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -72.9 percent change | Standard Error 11.58 |
| KPL-716: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -72.2 percent change | Standard Error 10.71 |
| KPL-716: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -68.7 percent change | Standard Error 9.18 |
| KPL-716: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -69.6 percent change | Standard Error 8.18 |
| KPL-716: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | -68.2 percent change | Standard Error 11.77 |
| Placebo: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 18 | -62.6 percent change | Standard Error 14.08 |
| Placebo: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 4 | 4.1 percent change | Standard Error 16.65 |
| Placebo: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 16 | -60.7 percent change | Standard Error 12.54 |
| Placebo: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 8 | -2.3 percent change | Standard Error 15.15 |
| Placebo: PPs Cohort | Percent Change From Baseline in DLQI Total Score Over Time | Change at Week 12 | -5.4 percent change | Standard Error 17.75 |
Comparison: Change at Week 4p-value: 0.228980% CI: [-98.77, 4.1]ANCOVA
Comparison: Change at Week 4p-value: 0.178880% CI: [0.96, 38.27]ANCOVA
Comparison: Change at Week 4p-value: 0.654480% CI: [-275.19, 156.06]ANCOVA
Comparison: Change at Week 4p-value: 0.002380% CI: [-99.39, -45.09]ANCOVA
Comparison: Change at Week 8p-value: 0.108180% CI: [-89.68, -14.47]ANCOVA
Comparison: Change at Week 8p-value: 0.492680% CI: [-13.39, 43.26]ANCOVA
Comparison: Change at Week 8p-value: 0.831580% CI: [-361.63, 467.98]ANCOVA
Comparison: Change at Week 8p-value: 0.001480% CI: [-94.61, -45.22]ANCOVA
Comparison: Change at Week 12p-value: 0.108180% CI: [-89.68, -14.47]ANCOVA
Comparison: Change at Week 12p-value: 0.733980% CI: [-21.65, 36.82]ANCOVA
Comparison: Change at Week 12p-value: 0.831580% CI: [-361.63, 467.98]ANCOVA
Comparison: Change at Week 12p-value: 0.005580% CI: [-95.92, -39.22]ANCOVA
Comparison: Change at Week 16p-value: 0.118880% CI: [-101.7, -14.15]ANCOVA
Comparison: Change at Week 16p-value: 0.869780% CI: [-21.26, 27.35]ANCOVA
Comparison: Change at Week 16p-value: 0.736880% CI: [-178.62, 117.94]ANCOVA
Comparison: Change at Week 16p-value: 0.557180% CI: [-29.03, 11.03]ANCOVA
Comparison: Change at Week 18p-value: 0.225180% CI: [-101.8, 3.69]ANCOVA
Comparison: Change at Week 18p-value: 0.373380% CI: [-7.9, 42.48]ANCOVA
Comparison: Change at Week 18p-value: 0.766280% CI: [-148.16, 102.89]ANCOVA
Comparison: Change at Week 18p-value: 0.724180% CI: [-28.54, 16.44]ANCOVA
Secondary
Percent Change From Baseline in ItchyQoL Total Score Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from never to all the time. The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -29.2 percent change | Standard Error 11.47 |
| KPL-716: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -36.6 percent change | Standard Error 12.16 |
| KPL-716: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -21.4 percent change | Standard Error 16.56 |
| KPL-716: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -41.7 percent change | Standard Error 14.66 |
| KPL-716: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -28.3 percent change | Standard Error 14.7 |
| Placebo: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | 0.2 percent change | Standard Error 20.91 |
| Placebo: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -0.2 percent change | Standard Error 23.57 |
| Placebo: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | 0.0 percent change | Standard Error 17.3 |
| Placebo: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -0.6 percent change | Standard Error 16.32 |
| Placebo: CIU Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -0.2 percent change | Standard Error 20.86 |
| KPL-716: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -26.5 percent change | Standard Error 6.61 |
| KPL-716: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -29.4 percent change | Standard Error 6.3 |
| KPL-716: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -13.0 percent change | Standard Error 5.15 |
| KPL-716: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -32.5 percent change | Standard Error 7.93 |
| KPL-716: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -23.7 percent change | Standard Error 7.21 |
| Placebo: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -27.6 percent change | Standard Error 9.17 |
| Placebo: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -26.0 percent change | Standard Error 9.01 |
| Placebo: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -23.2 percent change | Standard Error 7.65 |
| Placebo: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -24.3 percent change | Standard Error 6.43 |
| Placebo: CIP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -25.0 percent change | Standard Error 7.29 |
| KPL-716: LP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -50.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -29.1 percent change | Standard Error 7.02 |
| KPL-716: LP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -29.1 percent change | Standard Error 7.02 |
| KPL-716: LP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -54.6 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -69.2 percent change | Standard Error 0 |
| KPL-716: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -56.3 percent change | Standard Error 23.23 |
| KPL-716: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -58.2 percent change | Standard Error 15.85 |
| KPL-716: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -59.8 percent change | Standard Error 12.34 |
| KPL-716: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -63.8 percent change | Standard Error 7.49 |
| KPL-716: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -47.8 percent change | Standard Error 17.37 |
| Placebo: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | 12.0 percent change | Standard Error 42.18 |
| Placebo: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | 27.3 percent change | Standard Error 61.79 |
| Placebo: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | 39.7 percent change | Standard Error 46.22 |
| Placebo: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | 19.8 percent change | Standard Error 32.82 |
| Placebo: LSC Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | 10.2 percent change | Standard Error 19.94 |
| KPL-716: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -42.7 percent change | Standard Error 6.58 |
| KPL-716: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -42.7 percent change | Standard Error 6.29 |
| KPL-716: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -39.6 percent change | Standard Error 7.06 |
| KPL-716: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -45.8 percent change | Standard Error 6.06 |
| KPL-716: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -34.8 percent change | Standard Error 5.84 |
| Placebo: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 18 | -31.7 percent change | Standard Error 11 |
| Placebo: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 4 | -14.6 percent change | Standard Error 8.32 |
| Placebo: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 16 | -29.4 percent change | Standard Error 9.44 |
| Placebo: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 8 | -21.9 percent change | Standard Error 8.97 |
| Placebo: PPs Cohort | Percent Change From Baseline in ItchyQoL Total Score Over Time | Change at Week 12 | -26.0 percent change | Standard Error 10.25 |
Comparison: Change at Week 18p-value: 0.56480% CI: [-25.64, 9.94]ANCOVA
Comparison: Change at Week 4p-value: 0.519580% CI: [-68.69, 26.43]ANCOVA
Comparison: Change at Week 4p-value: 0.186980% CI: [0.34, 22.26]ANCOVA
Comparison: Change at Week 4p-value: 0.254580% CI: [-191.75, 16.79]ANCOVA
Comparison: Change at Week 4p-value: 0.064380% CI: [-33.88, -6.57]ANCOVA
Comparison: Change at Week 8p-value: 0.250380% CI: [-61.52, 4.35]ANCOVA
Comparison: Change at Week 8p-value: 0.846880% CI: [-13.08, 17.62]ANCOVA
Comparison: Change at Week 8p-value: 0.375580% CI: [-222.98, 55.18]ANCOVA
Comparison: Change at Week 8p-value: 0.075580% CI: [-35.58, -6.15]ANCOVA
Comparison: Change at Week 12p-value: 0.348680% CI: [-70.76, 13.65]ANCOVA
Comparison: Change at Week 12p-value: 0.655980% CI: [-17.28, 8.5]ANCOVA
Comparison: Change at Week 12p-value: 0.298780% CI: [-165.35, 24.94]ANCOVA
Comparison: Change at Week 12p-value: 0.196680% CI: [-33.29, -0.13]ANCOVA
Comparison: Change at Week 16p-value: 0.205180% CI: [-83.56, 0.62]ANCOVA
Comparison: Change at Week 16p-value: 0.751180% CI: [-16.79, 10.25]ANCOVA
Comparison: Change at Week 16p-value: 0.179780% CI: [-153.68, -5.59]ANCOVA
Comparison: Change at Week 16p-value: 0.171580% CI: [-31.61, -1.08]ANCOVA
Comparison: Change at Week 18p-value: 0.18580% CI: [-71.47, -1.63]ANCOVA
Comparison: Change at Week 18p-value: 0.690780% CI: [-21.15, 11.29]ANCOVA
Comparison: Change at Week 18p-value: 0.090180% CI: [-118.97, -29.02]ANCOVA
Secondary
Percent Change From Baseline in Pruritus VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -47.8 percent change | Standard Error 14.97 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -57.2 percent change | Standard Error 22.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -54.1 percent change | Standard Error 22.59 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -66.3 percent change | Standard Error 21.37 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -56.8 percent change | Standard Error 14.02 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -43.3 percent change | Standard Error 19.79 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -37.4 percent change | Standard Error 19.67 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -54.9 percent change | Standard Error 19.93 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -61.6 percent change | Standard Error 20.31 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -65.7 percent change | Standard Error 18.99 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -51.9 percent change | Standard Error 21.21 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -23.6 percent change | Standard Error 13.76 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -44.2 percent change | Standard Error 20.4 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | 4.4 percent change | Standard Error 29.24 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -0.9 percent change | Standard Error 28.57 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | 6.8 percent change | Standard Error 21.45 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -8.3 percent change | Standard Error 19.72 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | 3.3 percent change | Standard Error 30.4 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -4.3 percent change | Standard Error 28.19 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -1.2 percent change | Standard Error 32.37 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | 0.1 percent change | Standard Error 27.22 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | 5.1 percent change | Standard Error 20.09 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -2.6 percent change | Standard Error 28.36 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -0.4 percent change | Standard Error 32.38 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | 0.7 percent change | Standard Error 29.11 |
| Placebo: CIU Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -0.2 percent change | Standard Error 30.63 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -52.1 percent change | Standard Error 11.11 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -55.7 percent change | Standard Error 10.97 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -34.2 percent change | Standard Error 9.66 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -15.3 percent change | Standard Error 9.17 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -49.5 percent change | Standard Error 11.91 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -37.4 percent change | Standard Error 12.12 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -60.8 percent change | Standard Error 11.32 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -44.4 percent change | Standard Error 10.57 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -56.3 percent change | Standard Error 12.44 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -54.1 percent change | Standard Error 10.84 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -50.7 percent change | Standard Error 10.73 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -53.0 percent change | Standard Error 11.31 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -49.1 percent change | Standard Error 13.66 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -60.4 percent change | Standard Error 13.52 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -45.0 percent change | Standard Error 15.77 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -72.2 percent change | Standard Error 12.39 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -60.8 percent change | Standard Error 13.68 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -24.8 percent change | Standard Error 11.44 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -44.5 percent change | Standard Error 15.12 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -48.9 percent change | Standard Error 13.75 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -32.8 percent change | Standard Error 12.04 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -55.0 percent change | Standard Error 13.86 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -58.7 percent change | Standard Error 14.37 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -50.7 percent change | Standard Error 13.18 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -51.2 percent change | Standard Error 13.07 |
| Placebo: CIP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -52.4 percent change | Standard Error 14.11 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -44.3 percent change | Standard Error 21.36 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -5.3 percent change | Standard Error 1.8 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -5.1 percent change | Standard Error 3.22 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -26.2 percent change | Standard Error 8.32 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -37.3 percent change | Standard Error 12.6 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -40.0 percent change | Standard Error 15.97 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -41.6 percent change | Standard Error 17.99 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -44.3 percent change | Standard Error 21.36 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -76.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -69.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -72.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -76.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -74.6 percent change | Standard Error 0 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -99.2 percent change | Standard Error 23.11 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -102.9 percent change | Standard Error 21.13 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -101.3 percent change | Standard Error 9.93 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -93.6 percent change | Standard Error 28.13 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -101.0 percent change | Standard Error 24.68 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -101.8 percent change | Standard Error 22.55 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -102.0 percent change | Standard Error 16.87 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -79.6 percent change | Standard Error 34.28 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -103.3 percent change | Standard Error 19.74 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -76.1 percent change | Standard Error 27.14 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -99.4 percent change | Standard Error 26.68 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -97.1 percent change | Standard Error 28.92 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -103.9 percent change | Standard Error 22.62 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | 76.3 percent change | Standard Error 78.14 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | 63.8 percent change | Standard Error 73.18 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | 64.0 percent change | Standard Error 84.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | 57.5 percent change | Standard Error 71.64 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | 74.8 percent change | Standard Error 89.08 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | 46.3 percent change | Standard Error 66.92 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | 96.7 percent change | Standard Error 91.57 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | 29.5 percent change | Standard Error 31.43 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | 64.5 percent change | Standard Error 62.52 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | 81.3 percent change | Standard Error 108.56 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | 57.2 percent change | Standard Error 53.41 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | 90.9 percent change | Standard Error 85.95 |
| Placebo: LSC Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | 73.6 percent change | Standard Error 71.4 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -69.6 percent change | Standard Error 8.91 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -70.9 percent change | Standard Error 8.44 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -68.1 percent change | Standard Error 9.43 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -52.5 percent change | Standard Error 6.54 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -52.7 percent change | Standard Error 6.55 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -24.2 percent change | Standard Error 5.5 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -64.6 percent change | Standard Error 7.89 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -63.5 percent change | Standard Error 6.9 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -70.6 percent change | Standard Error 8.32 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -15.4 percent change | Standard Error 3.19 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -67.6 percent change | Standard Error 8.32 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -64.5 percent change | Standard Error 10.23 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -40.6 percent change | Standard Error 6.26 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 3 | -10.3 percent change | Standard Error 8.87 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 6 | -21.5 percent change | Standard Error 9.77 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 18 | -46.0 percent change | Standard Error 15.63 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 14 | -42.5 percent change | Standard Error 13.61 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 2 | -10.1 percent change | Standard Error 7.78 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 5 | -19.1 percent change | Standard Error 9.26 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 8 | -25.2 percent change | Standard Error 11.96 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 7 | -25.4 percent change | Standard Error 11.18 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 16 | -41.6 percent change | Standard Error 14.4 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 1 | -4.6 percent change | Standard Error 4.52 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 4 | -16.0 percent change | Standard Error 9.27 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 10 | -36.2 percent change | Standard Error 12.71 |
| Placebo: PPs Cohort | Percent Change From Baseline in Pruritus VAS Over Time | Change at Week 12 | -45.5 percent change | Standard Error 12.71 |
Comparison: Change at Week 3p-value: 0.226180% CI: [-405.34, 17.67]ANCOVA
Comparison: Change at Week 1p-value: 0.576380% CI: [-55.37, 24.78]ANCOVA
Comparison: Change at Week 1p-value: 0.521480% CI: [-9.86, 29.01]ANCOVA
Comparison: Change at Week 1p-value: 0.253680% CI: [-365.51, 31.54]ANCOVA
Comparison: Change at Week 1p-value: 0.06780% CI: [-18.2, -3.44]ANCOVA
Comparison: Change at Week 2p-value: 0.413380% CI: [-90.43, 24.15]ANCOVA
Comparison: Change at Week 2p-value: 0.930580% CI: [-21.83, 19.11]ANCOVA
Comparison: Change at Week 2p-value: 0.349980% CI: [-411.65, 89.86]ANCOVA
Comparison: Change at Week 2p-value: 0.158880% CI: [-26.74, -1.33]ANCOVA
Comparison: Change at Week 3p-value: 0.331980% CI: [-98.26, 17]ANCOVA
Comparison: Change at Week 3p-value: 0.717980% CI: [-18.59, 32.8]ANCOVA
Comparison: Change at Week 3p-value: 0.012380% CI: [-44.75, -15.8]ANCOVA
Comparison: Change at Week 4p-value: 0.225380% CI: [-112.02, 4.09]ANCOVA
Comparison: Change at Week 4p-value: 0.714980% CI: [-16.14, 28.66]ANCOVA
Comparison: Change at Week 4p-value: 0.262780% CI: [-374.16, 37.36]ANCOVA
Comparison: Change at Week 4p-value: 0.004780% CI: [-51.87, -21.6]ANCOVA
Comparison: Change at Week 5p-value: 0.180380% CI: [-128.37, -3.88]ANCOVA
Comparison: Change at Week 5p-value: 0.717480% CI: [-16.62, 29.35]ANCOVA
Comparison: Change at Week 5p-value: 0.255180% CI: [-358.51, 31.72]ANCOVA
Comparison: Change at Week 5p-value: 0.008680% CI: [-48.58, -18.36]ANCOVA
Comparison: Change at Week 6p-value: 0.257680% CI: [-121.78, 9.78]ANCOVA
Comparison: Change at Week 6p-value: 0.972280% CI: [-24.62, 23.34]ANCOVA
Comparison: Change at Week 6p-value: 0.205180% CI: [-357.85, 3.13]ANCOVA
Comparison: Change at Week 6p-value: 0.002580% CI: [-57.98, -26.08]ANCOVA
Comparison: Change at Week 7p-value: 0.146580% CI: [-121.14, -10.5]ANCOVA
Comparison: Change at Week 7p-value: 0.773480% CI: [-18.13, 28.37]ANCOVA
Comparison: Change at Week 7p-value: 0.182680% CI: [-340.37, -10.56]ANCOVA
Comparison: Change at Week 7p-value: 0.010580% CI: [-57.4, -20.93]ANCOVA
Comparison: Change at Week 8p-value: 0.273780% CI: [-119.49, 12.09]ANCOVA
Comparison: Change at Week 8p-value: 0.869280% CI: [-20.59, 26.52]ANCOVA
Comparison: Change at Week 8p-value: 0.210680% CI: [-332.06, 5.99]ANCOVA
Comparison: Change at Week 8p-value: 0.00680% CI: [-65.19, -26.14]ANCOVA
Comparison: Change at Week 10p-value: 0.183180% CI: [-121.44, -3.13]ANCOVA
Comparison: Change at Week 10p-value: 0.206180% CI: [-0.31, 43.3]ANCOVA
Comparison: Change at Week 10p-value: 0.207380% CI: [-326.83, 4.12]ANCOVA
Comparison: Change at Week 10p-value: 0.037180% CI: [-54.62, -14.1]ANCOVA
Comparison: Change at Week 12p-value: 0.239380% CI: [-117.01, 6.54]ANCOVA
Comparison: Change at Week 12p-value: 0.901980% CI: [-22.91, 27.67]ANCOVA
Comparison: Change at Week 12p-value: 0.210380% CI: [-303.77, 5.35]ANCOVA
Comparison: Change at Week 12p-value: 0.163480% CI: [-42.4, -1.88]ANCOVA
Comparison: Change at Week 14p-value: 0.272780% CI: [-108.04, 10.8]ANCOVA
Comparison: Change at Week 14p-value: 0.583980% CI: [-32.65, 13.36]ANCOVA
Comparison: Change at Week 14p-value: 0.159780% CI: [-312.25, -23.45]ANCOVA
Comparison: Change at Week 14p-value: 0.113880% CI: [-48.81, -5.43]ANCOVA
Comparison: Change at Week 16p-value: 0.088880% CI: [-102.78, -21.13]ANCOVA
Comparison: Change at Week 16p-value: 0.974180% CI: [-24.79, 23.6]ANCOVA
Comparison: Change at Week 16p-value: 0.135480% CI: [-282.59, -35.87]ANCOVA
Comparison: Change at Week 16p-value: 0.142580% CI: [-49.41, -3.52]ANCOVA
Comparison: Change at Week 18p-value: 0.132680% CI: [-98.18, -11.01]ANCOVA
Comparison: Change at Week 18p-value: 0.843380% CI: [-31.95, 23.58]ANCOVA
Comparison: Change at Week 18p-value: 0.076880% CI: [-203.39, -58.19]ANCOVA
Comparison: Change at Week 18p-value: 0.334180% CI: [-43.49, 6.34]ANCOVA
Secondary
Percent Change From Baseline in Sleep Loss VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -46.8 percent change | Standard Error 28.92 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -38.1 percent change | Standard Error 25.21 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -60.0 percent change | Standard Error 22.57 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -47.3 percent change | Standard Error 11.94 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -25.1 percent change | Standard Error 20.89 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -47.6 percent change | Standard Error 34.25 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -49.5 percent change | Standard Error 19.46 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -56.5 percent change | Standard Error 27.85 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -60.3 percent change | Standard Error 23.36 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -54.0 percent change | Standard Error 29.23 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -49.5 percent change | Standard Error 20.04 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -53.6 percent change | Standard Error 13.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -57.0 percent change | Standard Error 17 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | 24.2 percent change | Standard Error 43.9 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | 20.9 percent change | Standard Error 35.07 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | 9.9 percent change | Standard Error 30.1 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 2.9 percent change | Standard Error 31.37 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | 27.7 percent change | Standard Error 17.93 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | 17.1 percent change | Standard Error 37.85 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 22.4 percent change | Standard Error 43.43 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | 22.9 percent change | Standard Error 25.53 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | 22.2 percent change | Standard Error 41.82 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | 27.2 percent change | Standard Error 29.21 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | 27.1 percent change | Standard Error 51.43 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | 19.5 percent change | Standard Error 33.89 |
| Placebo: CIU Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | 23.7 percent change | Standard Error 20.39 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | 12.4 percent change | Standard Error 30.69 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | 45.6 percent change | Standard Error 82.52 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -23.3 percent change | Standard Error 15.15 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -43.8 percent change | Standard Error 8.58 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -17.8 percent change | Standard Error 29.08 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | 9.9 percent change | Standard Error 44.29 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 244.8 percent change | Standard Error 239.53 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 484.2 percent change | Standard Error 401.19 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | 8.2 percent change | Standard Error 50.36 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -30.1 percent change | Standard Error 14.43 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -26.8 percent change | Standard Error 24.06 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -34.4 percent change | Standard Error 15.61 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -39.8 percent change | Standard Error 14.56 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -56.1 percent change | Standard Error 16.79 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -43.2 percent change | Standard Error 91.47 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -52.6 percent change | Standard Error 60.66 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -61.5 percent change | Standard Error 35.03 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -75.6 percent change | Standard Error 15.99 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 15.4 percent change | Standard Error 288.53 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -61.6 percent change | Standard Error 17.54 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 108.2 percent change | Standard Error 483.26 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -86.7 percent change | Standard Error 9.51 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -47.7 percent change | Standard Error 53.35 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -27.1 percent change | Standard Error 36.97 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -58.4 percent change | Standard Error 28.98 |
| Placebo: CIP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -69.0 percent change | Standard Error 17.3 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -75.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -38.5 percent change | Standard Error 13.99 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -45.3 percent change | Standard Error 22.49 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -71.1 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -74.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -41.1 percent change | Standard Error 17.26 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -75.0 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -41.6 percent change | Standard Error 17.91 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -5.1 percent change | Standard Error 1.04 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -71.1 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -45.3 percent change | Standard Error 22.49 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -4.1 percent change | Standard Error 2.48 |
| KPL-716: LP Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -27.6 percent change | Standard Error 7.82 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -83.4 percent change | Standard Error 18.87 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -70.4 percent change | Standard Error 28.63 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -45.5 percent change | Standard Error 27.7 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -55.1 percent change | Standard Error 29.83 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -66.1 percent change | Standard Error 33.17 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -67.0 percent change | Standard Error 28.94 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -89.9 percent change | Standard Error 11.26 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -79.2 percent change | Standard Error 21.45 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -83.1 percent change | Standard Error 18.68 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -83.9 percent change | Standard Error 17.07 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -84.2 percent change | Standard Error 17.92 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -83.0 percent change | Standard Error 19.35 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -85.9 percent change | Standard Error 16.02 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -14.3 percent change | Standard Error 38.81 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -31.1 percent change | Standard Error 40.73 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -14.4 percent change | Standard Error 42.45 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -15.2 percent change | Standard Error 48.76 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -30.2 percent change | Standard Error 42.89 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -28.9 percent change | Standard Error 65.09 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -6.5 percent change | Standard Error 43.97 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 4.2 percent change | Standard Error 65.78 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | 0.8 percent change | Standard Error 75.41 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -8.9 percent change | Standard Error 36.4 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | 22.1 percent change | Standard Error 67.8 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | 22.2 percent change | Standard Error 62.96 |
| Placebo: LSC Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -9.8 percent change | Standard Error 25.59 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -68.6 percent change | Standard Error 9.28 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -47.2 percent change | Standard Error 9.43 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | -37.9 percent change | Standard Error 11.3 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -68.2 percent change | Standard Error 8.29 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -61.6 percent change | Standard Error 11.11 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -62.3 percent change | Standard Error 10.19 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -69.3 percent change | Standard Error 9.15 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -23.9 percent change | Standard Error 8.2 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -59.4 percent change | Standard Error 8.54 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -66.0 percent change | Standard Error 9.77 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -12.7 percent change | Standard Error 5.2 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -34.7 percent change | Standard Error 7.29 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -66.1 percent change | Standard Error 8.84 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 1 | -0.3 percent change | Standard Error 7.56 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 5 | -15.7 percent change | Standard Error 13.7 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 2 | -5.1 percent change | Standard Error 11.91 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 4 | 2.4 percent change | Standard Error 16.42 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 14 | -38.0 percent change | Standard Error 14.39 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 8 | -29.0 percent change | Standard Error 13.29 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 3 | -16.9 percent change | Standard Error 10.59 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 12 | -41.9 percent change | Standard Error 13.71 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 18 | -43.6 percent change | Standard Error 17.22 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 7 | -24.3 percent change | Standard Error 14.8 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 10 | -39.9 percent change | Standard Error 12.85 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 6 | -21.7 percent change | Standard Error 12.42 |
| Placebo: PPs Cohort | Percent Change From Baseline in Sleep Loss VAS Over Time | Change at Week 16 | -36.7 percent change | Standard Error 15.16 |
Comparison: Change at Week 1p-value: 0.558780% CI: [-462.83, 1214.97]ANCOVA
Comparison: Change at Week 1p-value: 0.540380% CI: [-94.32, 38.46]ANCOVA
Comparison: Change at Week 1p-value: 0.451680% CI: [-205.33, 69.93]ANCOVA
Comparison: Change at Week 1p-value: 0.205280% CI: [-25.13, 0.15]ANCOVA
Comparison: Change at Week 2p-value: 0.22480% CI: [-123.09, 4.28]ANCOVA
Comparison: Change at Week 2p-value: 0.424280% CI: [-24.7, 103.65]ANCOVA
Comparison: Change at Week 2p-value: 0.429580% CI: [-225.44, 71.01]ANCOVA
Comparison: Change at Week 2p-value: 0.227280% CI: [-38.64, 1.2]ANCOVA
Comparison: Change at Week 3p-value: 0.341680% CI: [-135.23, 24.95]ANCOVA
Comparison: Change at Week 3p-value: 0.419280% CI: [-35.02, 150.19]ANCOVA
Comparison: Change at Week 3p-value: 0.524580% CI: [-231.66, 98.02]ANCOVA
Comparison: Change at Week 3p-value: 0.198880% CI: [-35.47, -0.05]ANCOVA
Comparison: Change at Week 4p-value: 0.305480% CI: [-161.08, 22.72]ANCOVA
Comparison: Change at Week 4p-value: 0.550480% CI: [-271.51, 730.22]ANCOVA
Comparison: Change at Week 4p-value: 0.449380% CI: [-214.96, 72.65]ANCOVA
Comparison: Change at Week 4p-value: 0.066580% CI: [-67.74, -12.85]ANCOVA
Comparison: Change at Week 5p-value: 0.241180% CI: [-167.25, 9.75]ANCOVA
Comparison: Change at Week 5p-value: 0.452880% CI: [-44.51, 166.08]ANCOVA
Comparison: Change at Week 5p-value: 0.638180% CI: [-183.72, 100.85]ANCOVA
Comparison: Change at Week 5p-value: 0.083780% CI: [-54.44, -8.62]ANCOVA
Comparison: Change at Week 6p-value: 0.342880% CI: [-183.53, 34.13]ANCOVA
Comparison: Change at Week 6p-value: 0.353380% CI: [-8.63, 52.27]ANCOVA
Comparison: Change at Week 6p-value: 0.375580% CI: [-170.51, 42.66]ANCOVA
Comparison: Change at Week 6p-value: 0.026880% CI: [-58.39, -16.87]ANCOVA
Comparison: Change at Week 7p-value: 0.167280% CI: [-151.2, -7.75]ANCOVA
Comparison: Change at Week 7p-value: 0.351880% CI: [-17.09, 104.55]ANCOVA
Comparison: Change at Week 7p-value: 0.297480% CI: [-161.52, 24.09]ANCOVA
Comparison: Change at Week 7p-value: 0.055580% CI: [-62.83, -13.33]ANCOVA
Comparison: Change at Week 8p-value: 0.261480% CI: [-171.17, 14.62]ANCOVA
Comparison: Change at Week 8p-value: 0.413480% CI: [-18.62, 81.98]ANCOVA
Comparison: Change at Week 8p-value: 0.26280% CI: [-154.44, 15.24]ANCOVA
Comparison: Change at Week 8p-value: 0.026980% CI: [-62.46, -18.02]ANCOVA
Comparison: Change at Week 10p-value: 0.170980% CI: [-155.46, -7.02]ANCOVA
Comparison: Change at Week 10p-value: 0.004280% CI: [25.61, 60.22]ANCOVA
Comparison: Change at Week 10p-value: 0.377280% CI: [-142.19, 35.88]ANCOVA
Comparison: Change at Week 10p-value: 0.085780% CI: [-49.06, -7.63]ANCOVA
Comparison: Change at Week 12p-value: 0.060780% CI: [-120.48, -34.2]ANCOVA
Comparison: Change at Week 12p-value: 0.486280% CI: [-77.57, 255.22]ANCOVA
Comparison: Change at Week 12p-value: 0.396880% CI: [-146.96, 40.58]ANCOVA
Comparison: Change at Week 12p-value: 0.162480% CI: [-46.31, -2.11]ANCOVA
Comparison: Change at Week 14p-value: 0.134980% CI: [-138.58, -14.93]ANCOVA
Comparison: Change at Week 14p-value: 0.052580% CI: [16.38, 74.56]ANCOVA
Comparison: Change at Week 14p-value: 0.271980% CI: [-172.71, 19.55]ANCOVA
Comparison: Change at Week 14p-value: 0.095780% CI: [-53.86, -7.49]ANCOVA
Comparison: Change at Week 16p-value: 0.094280% CI: [-133.83, -25.78]ANCOVA
Comparison: Change at Week 16p-value: 0.160680% CI: [3.16, 66.09]ANCOVA
Comparison: Change at Week 16p-value: 0.209680% CI: [-156.58, 2.58]ANCOVA
Comparison: Change at Week 16p-value: 0.127980% CI: [-53.74, -4.89]ANCOVA
Comparison: Change at Week 18p-value: 0.047980% CI: [-112.96, -37.08]ANCOVA
Comparison: Change at Week 18p-value: 0.1780% CI: [2.28, 63.37]ANCOVA
Comparison: Change at Week 18p-value: 0.114280% CI: [-136.03, -24.15]ANCOVA
Comparison: Change at Week 18p-value: 0.39880% CI: [-45.8, 9.71]ANCOVA
Secondary
Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 4 | -45.5 percent change | Standard Error 8.82 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 9 | -48.3 percent change | Standard Error 6.99 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 15 | -41.4 percent change | Standard Error 12.71 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 10 | -41.5 percent change | Standard Error 11.05 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 5 | -48.7 percent change | Standard Error 8.76 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 11 | -36.9 percent change | Standard Error 12.65 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 18 | -51.5 percent change | Standard Error 5.65 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 12 | -38.4 percent change | Standard Error 13.06 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 6 | -54.6 percent change | Standard Error 5.27 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 13 | -26.4 percent change | Standard Error 14.24 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 1 | -26.6 percent change | Standard Error 5.36 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 14 | -33.7 percent change | Standard Error 13.07 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 7 | -43.8 percent change | Standard Error 8.48 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 16 | -33.8 percent change | Standard Error 12.37 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 3 | -40.8 percent change | Standard Error 11.29 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 17 | -44.0 percent change | Standard Error 11.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 8 | -31.5 percent change | Standard Error 12.83 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 2 | -36.4 percent change | Standard Error 4.94 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 18 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 2 | -10.0 percent change | Standard Error 10 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 3 | -16.7 percent change | Standard Error 16.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 14 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 1 | -13.3 percent change | Standard Error 13.33 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 4 | -10.0 percent change | Standard Error 10 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 5 | -10.0 percent change | Standard Error 10 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 6 | -6.7 percent change | Standard Error 6.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 7 | -20.0 percent change | Standard Error 20 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 8 | -6.7 percent change | Standard Error 6.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 9 | -6.7 percent change | Standard Error 6.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 10 | -23.3 percent change | Standard Error 23.33 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 11 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 12 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 13 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 15 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 16 | -26.7 percent change | Standard Error 26.67 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Change at Week 17 | -26.7 percent change | Standard Error 26.67 |
Secondary
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -62.3 percent change | Standard Error 24.47 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -62.2 percent change | Standard Error 19.51 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -73.1 percent change | Standard Error 21.37 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -55.7 percent change | Standard Error 26.31 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -66.4 percent change | Standard Error 23.94 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -35.3 percent change | Standard Error 9.68 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -66.4 percent change | Standard Error 24.89 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -61.1 percent change | Standard Error 24.7 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -51.1 percent change | Standard Error 13.32 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -48.5 percent change | Standard Error 25.78 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -62.3 percent change | Standard Error 22.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -63.9 percent change | Standard Error 20.16 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -52.4 percent change | Standard Error 10.6 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -51.9 percent change | Standard Error 21 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -61.0 percent change | Standard Error 15.91 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -58.5 percent change | Standard Error 26.89 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -56.4 percent change | Standard Error 25.57 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -71.7 percent change | Standard Error 22.82 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -43.1 percent change | Standard Error 35.55 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -43.7 percent change | Standard Error 37.59 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -19.4 percent change | Standard Error 27.88 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -43.4 percent change | Standard Error 35.29 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -43.1 percent change | Standard Error 32.26 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -42.1 percent change | Standard Error 30.52 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -43.6 percent change | Standard Error 38.41 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -43.3 percent change | Standard Error 34.96 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -1.4 percent change | Standard Error 22.72 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | 55.9 percent change | Standard Error 15.15 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -25.8 percent change | Standard Error 30 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -36.4 percent change | Standard Error 32.59 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -43.1 percent change | Standard Error 34.2 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -43.7 percent change | Standard Error 36.52 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -40.9 percent change | Standard Error 28.8 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -34.9 percent change | Standard Error 19.03 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -22.2 percent change | Standard Error 13.83 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -44.0 percent change | Standard Error 36.83 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -4.9 percent change | Standard Error 8.21 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -48.1 percent change | Standard Error 10.22 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -43.3 percent change | Standard Error 10.71 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -31.2 percent change | Standard Error 7.8 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -45.5 percent change | Standard Error 7.86 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -50.6 percent change | Standard Error 8.32 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -46.0 percent change | Standard Error 11.47 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -42.1 percent change | Standard Error 8.81 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -43.5 percent change | Standard Error 9.52 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -50.5 percent change | Standard Error 8.27 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -47.8 percent change | Standard Error 10.02 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -47.5 percent change | Standard Error 9.49 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -54.1 percent change | Standard Error 8.75 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -44.1 percent change | Standard Error 8.74 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -49.4 percent change | Standard Error 9.01 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -43.4 percent change | Standard Error 10.02 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -43.2 percent change | Standard Error 9.82 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -45.1 percent change | Standard Error 9.46 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -64.3 percent change | Standard Error 11.08 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -67.0 percent change | Standard Error 9.67 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -26.6 percent change | Standard Error 9.88 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -48.7 percent change | Standard Error 9.38 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -48.7 percent change | Standard Error 10.6 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -50.3 percent change | Standard Error 12.88 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -50.4 percent change | Standard Error 13.8 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -60.6 percent change | Standard Error 11.42 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -61.5 percent change | Standard Error 9.95 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -68.9 percent change | Standard Error 9.97 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -60.3 percent change | Standard Error 10.47 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -47.9 percent change | Standard Error 10.52 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -60.6 percent change | Standard Error 9.2 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -69.4 percent change | Standard Error 8.7 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -61.9 percent change | Standard Error 11.3 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -69.8 percent change | Standard Error 10.86 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -64.0 percent change | Standard Error 11.08 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -68.2 percent change | Standard Error 10.53 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -72.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -39.8 percent change | Standard Error 26.65 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -20.0 percent change | Standard Error 15.28 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -46.3 percent change | Standard Error 23.22 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -3.6 percent change | Standard Error 1.17 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -46.3 percent change | Standard Error 23.22 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -74.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -10.9 percent change | Standard Error 5.13 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -37.2 percent change | Standard Error 28.02 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -31.4 percent change | Standard Error 27.58 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -66.9 percent change | Standard Error 0 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -80.6 percent change | Standard Error 23.28 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -80.0 percent change | Standard Error 24.71 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -86.7 percent change | Standard Error 16.48 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -67.6 percent change | Standard Error 21.14 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -89.3 percent change | Standard Error 13.31 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -64.8 percent change | Standard Error 24.87 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -84.6 percent change | Standard Error 19.01 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -77.0 percent change | Standard Error 28.52 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -78.0 percent change | Standard Error 27.25 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -59.3 percent change | Standard Error 23.1 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -89.3 percent change | Standard Error 13.31 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -42.9 percent change | Standard Error 17.69 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -82.1 percent change | Standard Error 21.38 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -86.2 percent change | Standard Error 17.11 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -83.6 percent change | Standard Error 20.28 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -85.2 percent change | Standard Error 18.38 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -79.0 percent change | Standard Error 25.98 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -73.1 percent change | Standard Error 23.65 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -40.3 percent change | Standard Error 56.72 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -0.5 percent change | Standard Error 48.09 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -16.8 percent change | Standard Error 27.7 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -7.4 percent change | Standard Error 36.83 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -15.1 percent change | Standard Error 27.7 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -21.8 percent change | Standard Error 34.3 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -35.5 percent change | Standard Error 48.46 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -30.3 percent change | Standard Error 51.45 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -14.2 percent change | Standard Error 44 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -25.2 percent change | Standard Error 42.21 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -30.3 percent change | Standard Error 54.08 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -37.1 percent change | Standard Error 44.5 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -28.5 percent change | Standard Error 35.62 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -15.4 percent change | Standard Error 49.24 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -30.2 percent change | Standard Error 38.26 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -6.2 percent change | Standard Error 51.77 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -38.6 percent change | Standard Error 59.36 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -21.9 percent change | Standard Error 39.57 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -48.4 percent change | Standard Error 7.51 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -64.3 percent change | Standard Error 8.48 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -36.3 percent change | Standard Error 6.64 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -63.2 percent change | Standard Error 8.55 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -62.0 percent change | Standard Error 8.7 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -58.9 percent change | Standard Error 8.47 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -60.6 percent change | Standard Error 9.18 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -61.7 percent change | Standard Error 9.25 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -53.7 percent change | Standard Error 11.52 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -60.2 percent change | Standard Error 9.9 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -27.6 percent change | Standard Error 6.38 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | -9.3 percent change | Standard Error 2.32 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -15.0 percent change | Standard Error 3.5 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -52.7 percent change | Standard Error 7.4 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -58.9 percent change | Standard Error 9.71 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -57.2 percent change | Standard Error 8.21 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -58.5 percent change | Standard Error 8.78 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -53.4 percent change | Standard Error 11.61 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 6 | -19.0 percent change | Standard Error 10.63 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 12 | -33.7 percent change | Standard Error 12.6 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 7 | -24.5 percent change | Standard Error 11.79 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 10 | -31.5 percent change | Standard Error 12.5 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 5 | -20.8 percent change | Standard Error 10.78 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 15 | -38.3 percent change | Standard Error 14.22 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 3 | -11.2 percent change | Standard Error 9.16 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 8 | -27.5 percent change | Standard Error 12.29 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 11 | -33.2 percent change | Standard Error 12.17 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 18 | -41.8 percent change | Standard Error 16.68 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 9 | -32.3 percent change | Standard Error 12.17 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 4 | -12.2 percent change | Standard Error 9.53 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 14 | -34.1 percent change | Standard Error 13.28 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 16 | -37.0 percent change | Standard Error 13.95 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 2 | -9.3 percent change | Standard Error 5.03 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 17 | -41.2 percent change | Standard Error 16.54 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 1 | 1.2 percent change | Standard Error 3.33 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Change at Week 13 | -34.1 percent change | Standard Error 13.19 |
Comparison: Change at Week 1p-value: 0.497980% CI: [-41.17, 14.86]ANCOVA
Comparison: Change at Week 1p-value: 0.107980% CI: [4.63, 38.83]ANCOVA
Comparison: Change at Week 1p-value: 0.483780% CI: [-114.19, 43.07]ANCOVA
Comparison: Change at Week 1p-value: 0.020880% CI: [-15.99, -4.98]ANCOVA
Comparison: Change at Week 2p-value: 0.541380% CI: [-54.74, 22.38]ANCOVA
Comparison: Change at Week 2p-value: 0.168380% CI: [1.28, 33.74]ANCOVA
Comparison: Change at Week 2p-value: 0.393380% CI: [-161.43, 43.89]ANCOVA
Comparison: Change at Week 2p-value: 0.370580% CI: [-14.06, 2.58]ANCOVA
Comparison: Change at Week 3p-value: 0.564480% CI: [-81.36, 35.34]ANCOVA
Comparison: Change at Week 3p-value: 0.638480% CI: [-11.75, 24.94]ANCOVA
Comparison: Change at Week 3p-value: 0.422980% CI: [-169.13, 51.95]ANCOVA
Comparison: Change at Week 3p-value: 0.168880% CI: [-31.47, -1.18]ANCOVA
Comparison: Change at Week 4p-value: 0.124380% CI: [-105.59, -13.53]ANCOVA
Comparison: Change at Week 4p-value: 0.684180% CI: [-15.35, 29.22]ANCOVA
Comparison: Change at Week 4p-value: 0.396380% CI: [-147.31, 40.59]ANCOVA
Comparison: Change at Week 4p-value: 0.057180% CI: [-39.85, -8.32]ANCOVA
Comparison: Change at Week 5p-value: 0.445780% CI: [-101.32, 30.73]ANCOVA
Comparison: Change at Week 5p-value: 0.807580% CI: [-19.44, 28.32]ANCOVA
Comparison: Change at Week 5p-value: 0.409380% CI: [-162.84, 47.4]ANCOVA
Comparison: Change at Week 5p-value: 0.054380% CI: [-45.42, -9.76]ANCOVA
Comparison: Change at Week 6p-value: 0.471180% CI: [-92.88, 30.78]ANCOVA
Comparison: Change at Week 6p-value: 0.392580% CI: [-6.74, 32.79]ANCOVA
Comparison: Change at Week 6p-value: 0.509580% CI: [-164.22, 66.72]ANCOVA
Comparison: Change at Week 6p-value: 0.019980% CI: [-51.35, -16.18]ANCOVA
Comparison: Change at Week 7p-value: 0.302980% CI: [-99.26, 13.69]ANCOVA
Comparison: Change at Week 7p-value: 0.409480% CI: [-6.28, 28.16]ANCOVA
Comparison: Change at Week 7p-value: 0.482880% CI: [-159.63, 60.05]ANCOVA
Comparison: Change at Week 7p-value: 0.038380% CI: [-52.26, -13.26]ANCOVA
Comparison: Change at Week 8p-value: 0.532280% CI: [-86.66, 34.65]ANCOVA
Comparison: Change at Week 8p-value: 0.657780% CI: [-24.38, 12.03]ANCOVA
Comparison: Change at Week 8p-value: 0.625980% CI: [-165.08, 88.4]ANCOVA
Comparison: Change at Week 8p-value: 0.031280% CI: [-56.01, -15.38]ANCOVA
Comparison: Change at Week 9p-value: 0.010380% CI: [-138.97, -77.61]ANCOVA
Comparison: Change at Week 9p-value: 0.43380% CI: [-6.59, 26.56]ANCOVA
Comparison: Change at Week 9p-value: 0.616580% CI: [-158.82, 83.39]ANCOVA
Comparison: Change at Week 9p-value: 0.048880% CI: [-52.11, -11.84]ANCOVA
Comparison: Change at Week 10p-value: 0.663680% CI: [-84.53, 46.16]ANCOVA
Comparison: Change at Week 10p-value: 0.058380% CI: [8.18, 39.52]ANCOVA
Comparison: Change at Week 10p-value: 0.497580% CI: [-148.55, 58.36]ANCOVA
Comparison: Change at Week 10p-value: 0.065380% CI: [-51.17, -9.82]ANCOVA
Comparison: Change at Week 11p-value: 0.631680% CI: [-95.42, 48.62]ANCOVA
Comparison: Change at Week 11p-value: 0.087480% CI: [7.05, 46.18]ANCOVA
Comparison: Change at Week 11p-value: 0.466280% CI: [-139.99, 50.03]ANCOVA
Comparison: Change at Week 11p-value: 0.107380% CI: [-45.76, -5.51]ANCOVA
Comparison: Change at Week 12p-value: 0.619780% CI: [-92.62, 45.96]ANCOVA
Comparison: Change at Week 12p-value: 0.186880% CI: [0.63, 40.55]ANCOVA
Comparison: Change at Week 12p-value: 0.332180% CI: [-136.65, 26.71]ANCOVA
Comparison: Change at Week 12p-value: 0.13180% CI: [-45.64, -3.95]ANCOVA
Comparison: Change at Week 13p-value: 0.812880% CI: [-88.15, 64.13]ANCOVA
Comparison: Change at Week 13p-value: 0.100480% CI: [5.75, 43.69]ANCOVA
Comparison: Change at Week 13p-value: 0.296280% CI: [-147.28, 21.71]ANCOVA
Comparison: Change at Week 13p-value: 0.123680% CI: [-48.31, -4.67]ANCOVA
Comparison: Change at Week 14p-value: 0.927680% CI: [-79.1, 70.11]ANCOVA
Comparison: Change at Week 14p-value: 0.165780% CI: [1.55, 37.45]ANCOVA
Comparison: Change at Week 14p-value: 0.346180% CI: [-148.54, 31.71]ANCOVA
Comparison: Change at Week 14p-value: 0.111880% CI: [-49.58, -5.64]ANCOVA
Comparison: Change at Week 15p-value: 0.691280% CI: [-89.75, 51.89]ANCOVA
Comparison: Change at Week 15p-value: 0.097380% CI: [5.5, 40.35]ANCOVA
Comparison: Change at Week 15p-value: 0.28980% CI: [-133.72, 18.37]ANCOVA
Comparison: Change at Week 15p-value: 0.23180% CI: [-45.43, 1.6]ANCOVA
Comparison: Change at Week 16p-value: 0.796780% CI: [-86.69, 61.28]ANCOVA
Comparison: Change at Week 16p-value: 0.286880% CI: [-3.5, 36.44]ANCOVA
Comparison: Change at Week 16p-value: 0.236980% CI: [-138.08, 8.37]ANCOVA
Comparison: Change at Week 16p-value: 0.222880% CI: [-44.97, 1.17]ANCOVA
Comparison: Change at Week 17p-value: 0.77480% CI: [-92.74, 62.89]ANCOVA
Comparison: Change at Week 17p-value: 0.380% CI: [-3.74, 33.98]ANCOVA
Comparison: Change at Week 17p-value: 0.147280% CI: [-131.59, -13.3]ANCOVA
Comparison: Change at Week 17p-value: 0.553680% CI: [-39.77, 14.94]ANCOVA
Comparison: Change at Week 18p-value: 0.713180% CI: [-89.13, 53.84]ANCOVA
Comparison: Change at Week 18p-value: 0.376280% CI: [-6.49, 34.24]ANCOVA
Comparison: Change at Week 18p-value: 0.141980% CI: [-133.26, -14.97]ANCOVA
Comparison: Change at Week 18p-value: 0.581780% CI: [-39.22, 15.95]ANCOVA
Secondary
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -20.2 percent change | Standard Error 34.79 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -1.0 percent change | Standard Error 32.15 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -21.5 percent change | Standard Error 41.87 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -28.7 percent change | Standard Error 15.95 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -41.8 percent change | Standard Error 31.93 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -19.5 percent change | Standard Error 40.74 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -48.6 percent change | Standard Error 28.92 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -15.5 percent change | Standard Error 39.26 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -33.5 percent change | Standard Error 35.42 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -25.0 percent change | Standard Error 31.15 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -25.9 percent change | Standard Error 37.2 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -20.4 percent change | Standard Error 42 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -25.7 percent change | Standard Error 42.76 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -24.0 percent change | Standard Error 35.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -20.9 percent change | Standard Error 47.36 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -29.3 percent change | Standard Error 34.97 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -23.2 percent change | Standard Error 37.03 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -29.0 percent change | Standard Error 31.17 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -50.1 percent change | Standard Error 59.26 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -29.9 percent change | Standard Error 57.65 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -50.4 percent change | Standard Error 67.03 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | 66.0 percent change | Standard Error 22.57 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -28.7 percent change | Standard Error 45.5 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -49.7 percent change | Standard Error 50.13 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -49.9 percent change | Standard Error 52.64 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -49.4 percent change | Standard Error 44.11 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -49.4 percent change | Standard Error 45.2 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -2.2 percent change | Standard Error 44.09 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -49.0 percent change | Standard Error 40.94 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -22.9 percent change | Standard Error 52.41 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -42.6 percent change | Standard Error 49.24 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -49.7 percent change | Standard Error 50.36 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -43.4 percent change | Standard Error 60.51 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -49.7 percent change | Standard Error 55.57 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -50.3 percent change | Standard Error 59.44 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -49.7 percent change | Standard Error 49.49 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -37.4 percent change | Standard Error 8.65 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -37.1 percent change | Standard Error 9.54 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -43.4 percent change | Standard Error 8.98 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -28.7 percent change | Standard Error 8.26 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -34.6 percent change | Standard Error 10.18 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -40.9 percent change | Standard Error 8.43 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -41.3 percent change | Standard Error 9.88 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -42.2 percent change | Standard Error 8.76 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -30.9 percent change | Standard Error 11.35 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -44.1 percent change | Standard Error 10.4 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -38.4 percent change | Standard Error 9.11 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -2.6 percent change | Standard Error 5.75 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -42.4 percent change | Standard Error 8.45 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -38.6 percent change | Standard Error 9.08 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -35.9 percent change | Standard Error 10.59 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -42.8 percent change | Standard Error 10.42 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -33.4 percent change | Standard Error 7.94 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -38.2 percent change | Standard Error 9.62 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -70.1 percent change | Standard Error 13.12 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -45.6 percent change | Standard Error 10.32 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -65.1 percent change | Standard Error 11.42 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -76.5 percent change | Standard Error 11.03 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -47.2 percent change | Standard Error 9.92 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -69.7 percent change | Standard Error 10.5 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -64.0 percent change | Standard Error 12.02 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -47.9 percent change | Standard Error 12.72 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -74.7 percent change | Standard Error 12.24 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -61.6 percent change | Standard Error 10.55 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -50.7 percent change | Standard Error 11.38 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -71.9 percent change | Standard Error 11.12 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -76.4 percent change | Standard Error 10 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -60.7 percent change | Standard Error 11.22 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -66.6 percent change | Standard Error 10.13 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -62.7 percent change | Standard Error 10.54 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -26.3 percent change | Standard Error 7.18 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -64.7 percent change | Standard Error 12.04 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -72.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -3.0 percent change | Standard Error 2.92 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -9.2 percent change | Standard Error 7.29 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -18.9 percent change | Standard Error 17.5 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -29.8 percent change | Standard Error 28.43 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -35.5 percent change | Standard Error 30.62 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -38.1 percent change | Standard Error 30.62 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -44.6 percent change | Standard Error 30.62 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -44.6 percent change | Standard Error 30.62 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -66.9 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -73.8 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -74.7 percent change | Standard Error 0 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -73.8 percent change | Standard Error 0 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -80.2 percent change | Standard Error 22.99 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -64.4 percent change | Standard Error 26.92 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -67.2 percent change | Standard Error 22.95 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -86.2 percent change | Standard Error 15.97 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -87.3 percent change | Standard Error 14.69 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -88.4 percent change | Standard Error 13.41 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -40.7 percent change | Standard Error 17.63 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -67.3 percent change | Standard Error 23.31 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -87.3 percent change | Standard Error 14.69 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -82.4 percent change | Standard Error 20.44 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -88.4 percent change | Standard Error 13.41 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -56.7 percent change | Standard Error 24.07 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -88.4 percent change | Standard Error 13.41 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -87.9 percent change | Standard Error 14.05 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -88.4 percent change | Standard Error 13.41 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -88.4 percent change | Standard Error 13.41 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -89.0 percent change | Standard Error 12.77 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -85.7 percent change | Standard Error 16.6 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -19.2 percent change | Standard Error 29.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -27.3 percent change | Standard Error 44.9 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -27.3 percent change | Standard Error 30.87 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -31.9 percent change | Standard Error 29.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -32.7 percent change | Standard Error 50.51 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -35.1 percent change | Standard Error 29.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -16.9 percent change | Standard Error 51.21 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -33.5 percent change | Standard Error 29.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -6.6 percent change | Standard Error 50.42 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -22.7 percent change | Standard Error 32.27 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | 6.3 percent change | Standard Error 59.14 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -19.1 percent change | Standard Error 28.06 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | 6.8 percent change | Standard Error 52.89 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -24.8 percent change | Standard Error 36.48 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -1.4 percent change | Standard Error 38.74 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -17.6 percent change | Standard Error 29.47 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -37.0 percent change | Standard Error 32.27 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -37.3 percent change | Standard Error 35.08 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -58.7 percent change | Standard Error 12.22 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -63.6 percent change | Standard Error 10.16 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -22.7 percent change | Standard Error 6.03 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -6.7 percent change | Standard Error 2.75 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -43.0 percent change | Standard Error 7.95 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -65.9 percent change | Standard Error 9.22 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -64.9 percent change | Standard Error 9.77 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -52.0 percent change | Standard Error 8.41 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -12.4 percent change | Standard Error 3.67 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -60.2 percent change | Standard Error 9.58 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -63.6 percent change | Standard Error 9.13 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -34.4 percent change | Standard Error 6.75 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -46.7 percent change | Standard Error 7.82 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -63.9 percent change | Standard Error 10.34 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -61.1 percent change | Standard Error 9.12 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -58.7 percent change | Standard Error 12.25 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -63.9 percent change | Standard Error 9.92 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -59.5 percent change | Standard Error 8.96 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 15 | -31.3 percent change | Standard Error 14.7 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 3 | -7.1 percent change | Standard Error 8.58 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 8 | -23.1 percent change | Standard Error 12.75 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 5 | -15.9 percent change | Standard Error 11.31 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 11 | -26.1 percent change | Standard Error 12.97 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 16 | -29.4 percent change | Standard Error 14.45 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 2 | -6.0 percent change | Standard Error 5.22 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 6 | -13.0 percent change | Standard Error 11.12 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 10 | -25.1 percent change | Standard Error 13.11 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 17 | -34.8 percent change | Standard Error 17.38 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 1 | -4.9 percent change | Standard Error 3.91 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 7 | -19.4 percent change | Standard Error 11.96 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 12 | -27.0 percent change | Standard Error 13.63 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 4 | -11.7 percent change | Standard Error 9.6 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 9 | -25.5 percent change | Standard Error 12.99 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 18 | -34.7 percent change | Standard Error 17.43 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 14 | -29.3 percent change | Standard Error 13.9 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Change at Week 13 | -28.4 percent change | Standard Error 14.11 |
Comparison: Change at Week 1p-value: 0.653280% CI: [-63.6, 119.06]ANCOVA
Comparison: Change at Week 1p-value: 0.018780% CI: [11.38, 35.85]ANCOVA
Comparison: Change at Week 1p-value: 0.470780% CI: [-123.27, 44.68]ANCOVA
Comparison: Change at Week 1p-value: 0.710880% CI: [-8.22, 4.59]ANCOVA
Comparison: Change at Week 2p-value: 0.735580% CI: [-76.47, 121.23]ANCOVA
Comparison: Change at Week 2p-value: 0.216780% CI: [-0.66, 34.52]ANCOVA
Comparison: Change at Week 2p-value: 0.405880% CI: [-178.16, 51.13]ANCOVA
Comparison: Change at Week 2p-value: 0.332380% CI: [-14.95, 2.15]ANCOVA
Comparison: Change at Week 3p-value: 0.649680% CI: [-77.29, 145.8]ANCOVA
Comparison: Change at Week 3p-value: 0.292580% CI: [-3.12, 30.7]ANCOVA
Comparison: Change at Week 3p-value: 0.407480% CI: [-198.92, 57.46]ANCOVA
Comparison: Change at Week 3p-value: 0.158480% CI: [-29.6, -1.49]ANCOVA
Comparison: Change at Week 4p-value: 0.701380% CI: [-111.31, 65.69]ANCOVA
Comparison: Change at Week 4p-value: 0.42380% CI: [-8.3, 35.05]ANCOVA
Comparison: Change at Week 4p-value: 0.405580% CI: [-169.9, 48.69]ANCOVA
Comparison: Change at Week 4p-value: 0.070980% CI: [-38.41, -6.96]ANCOVA
Comparison: Change at Week 5p-value: 0.826880% CI: [-103.77, 139.17]ANCOVA
Comparison: Change at Week 5p-value: 0.408280% CI: [-7.03, 31.75]ANCOVA
Comparison: Change at Week 5p-value: 0.481880% CI: [-161.43, 60.56]ANCOVA
Comparison: Change at Week 5p-value: 0.067380% CI: [-45.64, -8.58]ANCOVA
Comparison: Change at Week 6p-value: 0.742980% CI: [-105, 164.1]ANCOVA
Comparison: Change at Week 6p-value: 0.122780% CI: [3.88, 39.79]ANCOVA
Comparison: Change at Week 6p-value: 0.499680% CI: [-156.95, 62.02]ANCOVA
Comparison: Change at Week 6p-value: 0.024480% CI: [-51.87, -15.43]ANCOVA
Comparison: Change at Week 7p-value: 0.996780% CI: [-105.5, 104.92]ANCOVA
Comparison: Change at Week 7p-value: 0.173980% CI: [1.15, 37.12]ANCOVA
Comparison: Change at Week 7p-value: 0.397880% CI: [-152.39, 42.26]ANCOVA
Comparison: Change at Week 7p-value: 0.039780% CI: [-52.26, -13.07]ANCOVA
Comparison: Change at Week 8p-value: 0.892280% CI: [-105.32, 126.14]ANCOVA
Comparison: Change at Week 8p-value: 0.243980% CI: [-1.8, 36.45]ANCOVA
Comparison: Change at Week 8p-value: 0.307680% CI: [-120.29, 19.61]ANCOVA
Comparison: Change at Week 8p-value: 0.032280% CI: [-57.32, -15.55]ANCOVA
Comparison: Change at Week 9p-value: 0.041880% CI: [-139.98, -49.36]ANCOVA
Comparison: Change at Week 9p-value: 0.086580% CI: [6.49, 42.26]ANCOVA
Comparison: Change at Week 9p-value: 0.348980% CI: [-124.96, 27.11]ANCOVA
Comparison: Change at Week 9p-value: 0.028680% CI: [-59.34, -16.79]ANCOVA
Comparison: Change at Week 10p-value: 0.719880% CI: [-90.32, 147.59]ANCOVA
Comparison: Change at Week 10p-value: 0.008880% CI: [21.32, 56.63]ANCOVA
Comparison: Change at Week 10p-value: 0.237180% CI: [-120.39, 7.34]ANCOVA
Comparison: Change at Week 10p-value: 0.02180% CI: [-62.3, -19.35]ANCOVA
Comparison: Change at Week 11p-value: 0.731280% CI: [-68.17, 108.94]ANCOVA
Comparison: Change at Week 11p-value: 0.01580% CI: [19.88, 58.83]ANCOVA
Comparison: Change at Week 11p-value: 0.255980% CI: [-117.22, 10.52]ANCOVA
Comparison: Change at Week 11p-value: 0.041980% CI: [-56.21, -13.72]ANCOVA
Comparison: Change at Week 12p-value: 0.758980% CI: [-78.95, 119.74]ANCOVA
Comparison: Change at Week 12p-value: 0.037480% CI: [15.97, 62.31]ANCOVA
Comparison: Change at Week 12p-value: 0.246380% CI: [-118.8, 8.93]ANCOVA
Comparison: Change at Week 12p-value: 0.063280% CI: [-55.56, -10.9]ANCOVA
Comparison: Change at Week 13p-value: 0.705380% CI: [-75.41, 126.78]ANCOVA
Comparison: Change at Week 13p-value: 0.028580% CI: [17.09, 60.34]ANCOVA
Comparison: Change at Week 13p-value: 0.223680% CI: [-134.58, 5.32]ANCOVA
Comparison: Change at Week 13p-value: 0.055880% CI: [-58.65, -12.41]ANCOVA
Comparison: Change at Week 14p-value: 0.708980% CI: [-89.41, 149.24]ANCOVA
Comparison: Change at Week 14p-value: 0.034780% CI: [14.08, 53.35]ANCOVA
Comparison: Change at Week 14p-value: 0.283580% CI: [-139.99, 18.16]ANCOVA
Comparison: Change at Week 14p-value: 0.052580% CI: [-58.31, -12.77]ANCOVA
Comparison: Change at Week 15p-value: 0.734780% CI: [-81.68, 129.66]ANCOVA
Comparison: Change at Week 15p-value: 0.03980% CI: [12.5, 49.6]ANCOVA
Comparison: Change at Week 15p-value: 0.229980% CI: [-127.49, 6.33]ANCOVA
Comparison: Change at Week 15p-value: 0.088480% CI: [-56.7, -8.53]ANCOVA
Comparison: Change at Week 16p-value: 0.808580% CI: [-84.37, 116.87]ANCOVA
Comparison: Change at Week 16p-value: 0.228380% CI: [-1.33, 41.14]ANCOVA
Comparison: Change at Week 16p-value: 0.162580% CI: [-130.76, -9.11]ANCOVA
Comparison: Change at Week 16p-value: 0.070780% CI: [-57.87, -10.52]ANCOVA
Comparison: Change at Week 17p-value: 0.994480% CI: [-81.79, 82.55]ANCOVA
Comparison: Change at Week 17p-value: 0.132780% CI: [3.71, 44.05]ANCOVA
Comparison: Change at Week 17p-value: 0.177780% CI: [-133.09, -5.35]ANCOVA
Comparison: Change at Week 17p-value: 0.279680% CI: [-52.34, 4.61]ANCOVA
Comparison: Change at Week 18p-value: 0.899980% CI: [-83.15, 98.3]ANCOVA
Comparison: Change at Week 18p-value: 0.186780% CI: [0.68, 43.23]ANCOVA
Comparison: Change at Week 18p-value: 0.171780% CI: [-134.68, -6.94]ANCOVA
Comparison: Change at Week 18p-value: 0.279280% CI: [-52.5, 4.61]ANCOVA
Secondary
Percent Change From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time frame: Baseline, Weeks 1-18
Population: Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -53.6 percent change | Standard Error 24.07 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -54.5 percent change | Standard Error 20.93 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -57.3 percent change | Standard Error 21.58 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -55.0 percent change | Standard Error 23.07 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -50.0 percent change | Standard Error 21.31 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -37.2 percent change | Standard Error 12.11 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -53.6 percent change | Standard Error 20.68 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -46.8 percent change | Standard Error 20.94 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -47.2 percent change | Standard Error 22.72 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -46.9 percent change | Standard Error 18.33 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -23.5 percent change | Standard Error 8.22 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -55.4 percent change | Standard Error 21.36 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -50.4 percent change | Standard Error 20.87 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -50.0 percent change | Standard Error 20.26 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -48.9 percent change | Standard Error 19.96 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -51.1 percent change | Standard Error 19.68 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -50.7 percent change | Standard Error 21.56 |
| KPL-716: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -54.7 percent change | Standard Error 23.35 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -19.0 percent change | Standard Error 31.07 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -22.0 percent change | Standard Error 33.65 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -25.0 percent change | Standard Error 26.41 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -23.8 percent change | Standard Error 31.1 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -20.0 percent change | Standard Error 28.76 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -28.7 percent change | Standard Error 33.24 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -28.2 percent change | Standard Error 30.77 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -28.0 percent change | Standard Error 30.7 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -28.9 percent change | Standard Error 30.15 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -27.3 percent change | Standard Error 30.07 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -20.6 percent change | Standard Error 17.45 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -16.2 percent change | Standard Error 11.84 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -28.2 percent change | Standard Error 29.79 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -19.0 percent change | Standard Error 28.35 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -27.7 percent change | Standard Error 30.17 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -27.9 percent change | Standard Error 29.19 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -27.6 percent change | Standard Error 32.73 |
| Placebo: CIU Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -36.4 percent change | Standard Error 34.67 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -43.4 percent change | Standard Error 7.37 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -19.5 percent change | Standard Error 6.57 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -36.7 percent change | Standard Error 7.42 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -43.9 percent change | Standard Error 7.92 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -51.6 percent change | Standard Error 8.7 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -52.3 percent change | Standard Error 9.11 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -54.3 percent change | Standard Error 8.98 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -52.4 percent change | Standard Error 9.32 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -55.7 percent change | Standard Error 9.95 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -52.6 percent change | Standard Error 9.4 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -52.8 percent change | Standard Error 9.91 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -53.9 percent change | Standard Error 9.88 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -53.8 percent change | Standard Error 10.04 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -55.3 percent change | Standard Error 10.15 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -50.8 percent change | Standard Error 10.54 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -51.7 percent change | Standard Error 10.86 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -54.2 percent change | Standard Error 11 |
| KPL-716: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -51.5 percent change | Standard Error 12.05 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -18.3 percent change | Standard Error 8.2 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -38.4 percent change | Standard Error 9.87 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -48.1 percent change | Standard Error 11.19 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -48.6 percent change | Standard Error 11.5 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -61.4 percent change | Standard Error 11.45 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -40.6 percent change | Standard Error 10.84 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -49.0 percent change | Standard Error 12.18 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -51.4 percent change | Standard Error 11.72 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -47.9 percent change | Standard Error 11.36 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -53.2 percent change | Standard Error 11.42 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -43.7 percent change | Standard Error 12.7 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -36.5 percent change | Standard Error 9.25 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -58.7 percent change | Standard Error 10.86 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -31.5 percent change | Standard Error 9.19 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -44.7 percent change | Standard Error 12.54 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -48.8 percent change | Standard Error 11.63 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -52.2 percent change | Standard Error 11.59 |
| Placebo: CIP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -43.7 percent change | Standard Error 13.92 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -29.3 percent change | Standard Error 18.23 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -39.4 percent change | Standard Error 10.21 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -62.5 percent change | Standard Error 12.5 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -68.8 percent change | Standard Error 6.25 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -15.0 percent change | Standard Error 8.02 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -31.1 percent change | Standard Error 20.41 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -33.5 percent change | Standard Error 17.5 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -6.1 percent change | Standard Error 4.37 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -66.1 percent change | Standard Error 8.93 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -62.5 percent change | Standard Error 12.5 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -68.8 percent change | Standard Error 6.25 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -68.8 percent change | Standard Error 6.25 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -39.4 percent change | Standard Error 10.21 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -68.8 percent change | Standard Error 6.25 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -69.6 percent change | Standard Error 7.14 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -2.4 percent change | Standard Error 2.19 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -62.5 percent change | Standard Error 12.5 |
| KPL-716: LP Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -68.8 percent change | Standard Error 6.25 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -92.2 percent change | Standard Error 8.1 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -44.2 percent change | Standard Error 12.54 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -76.9 percent change | Standard Error 13.08 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -81.5 percent change | Standard Error 13.07 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -85.2 percent change | Standard Error 14 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -87.4 percent change | Standard Error 11.02 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -86.8 percent change | Standard Error 11.34 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -67.9 percent change | Standard Error 12.89 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -86.6 percent change | Standard Error 10.72 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -89.0 percent change | Standard Error 8.84 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -71.7 percent change | Standard Error 9.93 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -90.1 percent change | Standard Error 10.04 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -59.8 percent change | Standard Error 10.8 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -88.8 percent change | Standard Error 10.85 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -92.1 percent change | Standard Error 6.42 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -91.8 percent change | Standard Error 9.58 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -85.0 percent change | Standard Error 11.76 |
| KPL-716: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -90.6 percent change | Standard Error 9.28 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | 29.3 percent change | Standard Error 24.62 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | 7.0 percent change | Standard Error 29.8 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | 7.0 percent change | Standard Error 26.8 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | 16.9 percent change | Standard Error 28.6 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | 13.8 percent change | Standard Error 29.81 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | 9.1 percent change | Standard Error 21.17 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | 3.0 percent change | Standard Error 21.85 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | 4.1 percent change | Standard Error 14.63 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | 6.1 percent change | Standard Error 22.89 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | 4.0 percent change | Standard Error 31.91 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | 7.8 percent change | Standard Error 25.13 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | 10.7 percent change | Standard Error 24.74 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -0.4 percent change | Standard Error 24.44 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | 25.9 percent change | Standard Error 29.39 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -1.2 percent change | Standard Error 25.85 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -2.8 percent change | Standard Error 20.15 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | 6.8 percent change | Standard Error 18.46 |
| Placebo: LSC Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | 8.0 percent change | Standard Error 22.65 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -56.5 percent change | Standard Error 6.88 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -17.8 percent change | Standard Error 3.16 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -67.0 percent change | Standard Error 8.73 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -64.9 percent change | Standard Error 9.22 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -58.0 percent change | Standard Error 11.35 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -31.2 percent change | Standard Error 4.14 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -68.1 percent change | Standard Error 8.42 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -58.1 percent change | Standard Error 11.43 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -65.9 percent change | Standard Error 9.17 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -8.8 percent change | Standard Error 1.84 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -66.5 percent change | Standard Error 7.78 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -63.7 percent change | Standard Error 9.87 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -53.0 percent change | Standard Error 7.11 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -60.6 percent change | Standard Error 7.48 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -64.1 percent change | Standard Error 8.66 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -41.7 percent change | Standard Error 5.63 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -62.7 percent change | Standard Error 9.81 |
| KPL-716: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -62.2 percent change | Standard Error 8.85 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 6 | -18.7 percent change | Standard Error 9.72 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 7 | -22.5 percent change | Standard Error 10.57 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 8 | -29.0 percent change | Standard Error 11 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 17 | -30.8 percent change | Standard Error 16.05 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 9 | -28.5 percent change | Standard Error 11.91 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 3 | -11.2 percent change | Standard Error 5.86 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 10 | -24.5 percent change | Standard Error 12.35 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 11 | -24.8 percent change | Standard Error 12.25 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 18 | -31.1 percent change | Standard Error 16.17 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 12 | -24.8 percent change | Standard Error 12.52 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 2 | -8.4 percent change | Standard Error 4.46 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 13 | -25.2 percent change | Standard Error 13.03 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 14 | -26.1 percent change | Standard Error 12.97 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 15 | -29.5 percent change | Standard Error 13.96 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 1 | -3.4 percent change | Standard Error 2.61 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 16 | -29.3 percent change | Standard Error 13.88 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 5 | -17.7 percent change | Standard Error 10.05 |
| Placebo: PPs Cohort | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Change at Week 4 | -14.5 percent change | Standard Error 7.96 |
Comparison: Change at Week 2p-value: 0.991980% CI: [-15.83, 15.59]ANCOVA
Comparison: Change at Week 2p-value: 0.089180% CI: [-143.03, -35.31]ANCOVA
Comparison: Change at Week 2p-value: 0.102980% CI: [-16.67, -2.12]ANCOVA
Comparison: Change at Week 1p-value: 0.653380% CI: [-31.52, 16.84]ANCOVA
Comparison: Change at Week 1p-value: 0.907780% CI: [-15.16, 12.69]ANCOVA
Comparison: Change at Week 1p-value: 0.206580% CI: [-123.73, 1.39]ANCOVA
Comparison: Change at Week 1p-value: 0.113380% CI: [-9.56, -1.07]ANCOVA
Comparison: Change at Week 2p-value: 0.499780% CI: [-52.29, 18.98]ANCOVA
Comparison: Change at Week 3p-value: 0.553880% CI: [-75.82, 32.05]ANCOVA
Comparison: Change at Week 3p-value: 0.325280% CI: [-27.51, 3.73]ANCOVA
Comparison: Change at Week 3p-value: 0.110680% CI: [-158.11, -29.52]ANCOVA
Comparison: Change at Week 3p-value: 0.012380% CI: [-29.48, -10.4]ANCOVA
Comparison: Change at Week 4p-value: 0.479180% CI: [-87.63, 29.81]ANCOVA
Comparison: Change at Week 4p-value: 0.668480% CI: [-22.28, 11.27]ANCOVA
Comparison: Change at Week 4p-value: 0.093780% CI: [-129.22, -30.13]ANCOVA
Comparison: Change at Week 4p-value: 0.01280% CI: [-40.21, -14.27]ANCOVA
Comparison: Change at Week 5p-value: 0.492780% CI: [-101.39, 36.02]ANCOVA
Comparison: Change at Week 5p-value: 0.440980% CI: [-29.35, 7.49]ANCOVA
Comparison: Change at Week 5p-value: 0.119780% CI: [-155.96, -25.54]ANCOVA
Comparison: Change at Week 5p-value: 0.010280% CI: [-51.68, -18.92]ANOVA
Comparison: Change at Week 6p-value: 0.451580% CI: [-96.97, 30.02]ANCOVA
Comparison: Change at Week 6p-value: 0.762380% CI: [-23.76, 14.83]ANCOVA
Comparison: Change at Week 6p-value: 0.124780% CI: [-153.65, -23.29]ANCOVA
Comparison: Change at Week 6p-value: 0.005380% CI: [-53.59, -21.9]ANCOVA
Comparison: Change at Week 7p-value: 0.717780% CI: [-87.97, 53.62]ANCOVA
Comparison: Change at Week 7p-value: 0.668280% CI: [-25.26, 12.78]ANCOVA
Comparison: Change at Week 7p-value: 0.082380% CI: [-150.21, -40.24]ANCOVA
Comparison: Change at Week 7p-value: 0.008780% CI: [-55.38, -20.92]ANCOVA
Comparison: Change at Week 8p-value: 0.473480% CI: [-95.11, 31.76]ANCOVA
Comparison: Change at Week 8p-value: 0.81380% CI: [-23.33, 16.18]ANCOVA
Comparison: Change at Week 8p-value: 0.097980% CI: [-150.6, -33.32]ANCOVA
Comparison: Change at Week 8p-value: 0.012280% CI: [-55.48, -19.61]ANCOVA
Comparison: Change at Week 9p-value: 0.43180% CI: [-89.98, 25.81]ANCOVA
Comparison: Change at Week 9p-value: 0.645280% CI: [-27.38, 13.12]ANCOVA
Comparison: Change at Week 9p-value: 0.137580% CI: [-159.04, -19.44]ANCOVA
Comparison: Change at Week 9p-value: 0.014380% CI: [-58.97, -20.15]ANCOVA
Comparison: Change at Week 10p-value: 0.586780% CI: [-81.7, 37.52]ANCOVA
Comparison: Change at Week 10p-value: 0.674580% CI: [-12.99, 25.27]ANCOVA
Comparison: Change at Week 10p-value: 0.103980% CI: [-142.18, -29.09]ANCOVA
Comparison: Change at Week 10p-value: 0.011680% CI: [-62.6, -22.36]ANCOVA
Comparison: Change at Week 11p-value: 0.580780% CI: [-84.55, 38.26]ANCOVA
Comparison: Change at Week 11p-value: 0.576580% CI: [-11.55, 28.8]ANCOVA
Comparison: Change at Week 11p-value: 0.093380% CI: [-139.7, -32.75]ANCOVA
Comparison: Change at Week 11p-value: 0.017380% CI: [-59.29, -19.37]ANCOVA
Comparison: Change at Week 12p-value: 0.529380% CI: [-90.04, 35.62]ANCOVA
Comparison: Change at Week 12p-value: 0.967680% CI: [-20.73, 19.49]ANCOVA
Comparison: Change at Week 12p-value: 0.066380% CI: [-130.27, -42.11]ANCOVA
Comparison: Change at Week 12p-value: 0.025280% CI: [-57.81, -17.02]ANCOVA
Comparison: Change at Week 13p-value: 0.663780% CI: [-86.45, 47.22]ANCOVA
Comparison: Change at Week 13p-value: 0.917380% CI: [-22.04, 18.81]ANCOVA
Comparison: Change at Week 13p-value: 0.068580% CI: [-146.23, -46.1]ANCOVA
Comparison: Change at Week 13p-value: 0.02380% CI: [-60.91, -18.44]ANCOVA
Comparison: Change at Week 14p-value: 0.647180% CI: [-80.69, 42.54]ANCOVA
Comparison: Change at Week 14p-value: 0.804480% CI: [-24.56, 16.75]ANCOVA
Comparison: Change at Week 14p-value: 0.074180% CI: [-153.63, -45.37]ANCOVA
Comparison: Change at Week 14p-value: 0.021980% CI: [-61, -18.72]ANCOVA
Comparison: Change at Week 15p-value: 0.543680% CI: [-86.21, 35.46]ANCOVA
Comparison: Change at Week 15p-value: 0.914980% CI: [-23.2, 19.71]ANCOVA
Comparison: Change at Week 15p-value: 0.064680% CI: [-142.63, -47.05]ANCOVA
Comparison: Change at Week 15p-value: 0.061180% CI: [-56.89, -11.41]ANCOVA
Comparison: Change at Week 16p-value: 0.60680% CI: [-84.68, 40.71]ANCOVA
Comparison: Change at Week 16p-value: 0.682380% CI: [-29, 15.18]ANCOVA
Comparison: Change at Week 16p-value: 0.055680% CI: [-146.02, -53.41]ANCOVA
Comparison: Change at Week 16p-value: 0.065280% CI: [-55.98, -10.76]ANCOVA
Comparison: Change at Week 17p-value: 0.571480% CI: [-94.14, 41.62]ANCOVA
Comparison: Change at Week 17p-value: 0.538680% CI: [-32.93, 11.83]ANCOVA
Comparison: Change at Week 17p-value: 0.043880% CI: [-139.35, -58.6]ANCOVA
Comparison: Change at Week 17p-value: 0.182980% CI: [-53.38, -1.08]ANCOVA
Comparison: Change at Week 18p-value: 0.544380% CI: [-87.2, 35.94]ANCOVA
Comparison: Change at Week 18p-value: 0.674880% CI: [-32.39, 16.66]ANCOVA
Comparison: Change at Week 18p-value: 0.029780% CI: [-128.19, -64.19]ANCOVA
Comparison: Change at Week 18p-value: 0.189980% CI: [-53.33, -0.63]ANCOVA