Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases (NCT NCT03858634)
NCT ID: NCT03858634
Last Updated: 2025-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2025-03-18
Participant Flow
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.
Participant milestones
| Measure |
KPL-716
KPL-716 weekly for 8 weeks
|
Placebo
Placebo weekly for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
19
|
|
Overall Study
Participants With Chronic Idiopathic Urticaria (CIU)
|
4
|
2
|
|
Overall Study
Participants With Chronic Idiopathic Pruritus (CIP)
|
14
|
9
|
|
Overall Study
Participants With Lichen Planus (LP)
|
3
|
0
|
|
Overall Study
Participants With Lichen Simplex Chronicus (LSC)
|
4
|
1
|
|
Overall Study
Participants With Plaque Psoriasis (PPs)
|
14
|
7
|
|
Overall Study
COMPLETED
|
36
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
KPL-716
KPL-716 weekly for 8 weeks
|
Placebo
Placebo weekly for 8 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other, Not Specified
|
1
|
1
|
Baseline Characteristics
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Baseline characteristics by cohort
| Measure |
KPL-716
n=39 Participants
KPL-716 weekly for 8 weeks
|
Placebo
n=19 Participants
Placebo weekly for 8 weeks
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 13.94 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS)
|
8.1 score on a scale
STANDARD_DEVIATION 0.93 • n=5 Participants
|
8.3 score on a scale
STANDARD_DEVIATION 1.14 • n=7 Participants
|
8.2 score on a scale
STANDARD_DEVIATION 1.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average WI-NRS at Week 8
|
-4.3 score on a scale
Standard Error 1.84
|
-1.1 score on a scale
Standard Error 2.66
|
-4.3 score on a scale
Standard Error 0.77
|
-3.7 score on a scale
Standard Error 0.96
|
-3.1 score on a scale
Standard Error 0.82
|
—
|
-6.9 score on a scale
Standard Error 0.81
|
0.7 score on a scale
Standard Error 1.84
|
-5.6 score on a scale
Standard Error 0.69
|
-2.5 score on a scale
Standard Error 0.98
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
|
-50.7 percent change
Standard Error 21.56
|
-19.0 percent change
Standard Error 31.07
|
-52.4 percent change
Standard Error 9.32
|
-48.8 percent change
Standard Error 11.63
|
-39.4 percent change
Standard Error 10.21
|
—
|
-85.0 percent change
Standard Error 11.76
|
7.0 percent change
Standard Error 26.80
|
-66.5 percent change
Standard Error 7.78
|
-29.0 percent change
Standard Error 11.00
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 4
|
-3.9 score on a scale
Standard Error 1.59
|
-1.5 score on a scale
Standard Error 1.50
|
-3.5 score on a scale
Standard Error 0.64
|
-3.0 score on a scale
Standard Error 0.85
|
-2.3 score on a scale
Standard Error 1.78
|
—
|
-5.0 score on a scale
Standard Error 1.48
|
-2.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-3.4 score on a scale
Standard Error 0.48
|
-1.2 score on a scale
Standard Error 0.63
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 18
|
-4.4 score on a scale
Standard Error 1.67
|
-2.2 score on a scale
Standard Error 2.21
|
-4.3 score on a scale
Standard Error 0.97
|
-3.4 score on a scale
Standard Error 1.06
|
-5.6 score on a scale
Standard Error 0.57
|
—
|
-6.9 score on a scale
Standard Error 1.01
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 1.01
|
-2.7 score on a scale
Standard Error 1.39
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 1
|
-1.9 score on a scale
Standard Error 0.59
|
-0.9 score on a scale
Standard Error 0.86
|
-1.6 score on a scale
Standard Error 0.55
|
-1.4 score on a scale
Standard Error 0.45
|
-0.2 score on a scale
Standard Error 0.13
|
—
|
-3.0 score on a scale
Standard Error 1.23
|
-0.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-0.7 score on a scale
Standard Error 0.17
|
-0.2 score on a scale
Standard Error 0.16
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 2
|
-3.0 score on a scale
Standard Error 0.79
|
-1.3 score on a scale
Standard Error 1.29
|
-3.0 score on a scale
Standard Error 0.60
|
-2.9 score on a scale
Standard Error 0.63
|
-0.5 score on a scale
Standard Error 0.58
|
—
|
-4.0 score on a scale
Standard Error 1.64
|
-1.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-1.5 score on a scale
Standard Error 0.27
|
-0.7 score on a scale
Standard Error 0.26
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 5
|
-4.4 score on a scale
Standard Error 1.83
|
-1.6 score on a scale
Standard Error 1.64
|
-4.1 score on a scale
Standard Error 0.73
|
-3.1 score on a scale
Standard Error 0.88
|
-2.5 score on a scale
Standard Error 1.91
|
—
|
-5.4 score on a scale
Standard Error 1.58
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.4 score on a scale
Standard Error 0.65
|
-1.5 score on a scale
Standard Error 0.88
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 6
|
-4.6 score on a scale
Standard Error 1.72
|
-1.8 score on a scale
Standard Error 1.79
|
-4.2 score on a scale
Standard Error 0.74
|
-3.7 score on a scale
Standard Error 0.92
|
-2.7 score on a scale
Standard Error 1.90
|
—
|
-5.8 score on a scale
Standard Error 1.58
|
-2.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.7 score on a scale
Standard Error 0.65
|
-1.6 score on a scale
Standard Error 0.81
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 7
|
-4.4 score on a scale
Standard Error 1.75
|
-2.6 score on a scale
Standard Error 2.64
|
-4.4 score on a scale
Standard Error 0.77
|
-3.7 score on a scale
Standard Error 0.81
|
-3.1 score on a scale
Standard Error 1.94
|
—
|
-6.3 score on a scale
Standard Error 1.48
|
-2.3 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.1 score on a scale
Standard Error 0.69
|
-1.9 score on a scale
Standard Error 0.91
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 8
|
-4.1 score on a scale
Standard Error 1.84
|
-1.6 score on a scale
Standard Error 1.57
|
-4.3 score on a scale
Standard Error 0.75
|
-3.7 score on a scale
Standard Error 0.94
|
-3.1 score on a scale
Standard Error 1.94
|
—
|
-6.0 score on a scale
Standard Error 1.61
|
-2.7 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.6 score on a scale
Standard Error 0.66
|
-2.5 score on a scale
Standard Error 1.07
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 9
|
-4.1 score on a scale
Standard Error 1.73
|
-1.6 score on a scale
Standard Error 1.57
|
-4.6 score on a scale
Standard Error 0.88
|
-3.8 score on a scale
Standard Error 0.76
|
-5.0 score on a scale
Standard Error 1.00
|
—
|
-6.0 score on a scale
Standard Error 1.76
|
-3.3 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.7 score on a scale
Standard Error 0.70
|
-2.5 score on a scale
Standard Error 1.21
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 10
|
-4.1 score on a scale
Standard Error 1.69
|
-2.2 score on a scale
Standard Error 2.21
|
-4.3 score on a scale
Standard Error 0.87
|
-4.7 score on a scale
Standard Error 0.64
|
-5.0 score on a scale
Standard Error 1.00
|
—
|
-6.3 score on a scale
Standard Error 1.46
|
-3.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.6 score on a scale
Standard Error 0.75
|
-2.2 score on a scale
Standard Error 1.23
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 12
|
-4.5 score on a scale
Standard Error 1.72
|
-2.2 score on a scale
Standard Error 2.21
|
-4.4 score on a scale
Standard Error 0.86
|
-4.3 score on a scale
Standard Error 0.76
|
-5.3 score on a scale
Standard Error 0.71
|
—
|
-6.5 score on a scale
Standard Error 1.27
|
-2.7 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.3 score on a scale
Standard Error 0.80
|
-2.2 score on a scale
Standard Error 1.21
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 13
|
-3.9 score on a scale
Standard Error 1.85
|
-2.2 score on a scale
Standard Error 2.21
|
-4.4 score on a scale
Standard Error 0.83
|
-4.2 score on a scale
Standard Error 0.86
|
-5.5 score on a scale
Standard Error 0.50
|
—
|
-6.6 score on a scale
Standard Error 1.32
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.5 score on a scale
Standard Error 0.83
|
-2.3 score on a scale
Standard Error 1.22
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 14
|
-3.8 score on a scale
Standard Error 1.75
|
-2.2 score on a scale
Standard Error 2.21
|
-4.5 score on a scale
Standard Error 0.80
|
-4.1 score on a scale
Standard Error 0.92
|
-5.5 score on a scale
Standard Error 0.50
|
—
|
-6.4 score on a scale
Standard Error 1.42
|
-1.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.6 score on a scale
Standard Error 0.81
|
-2.3 score on a scale
Standard Error 1.21
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 15
|
-4.4 score on a scale
Standard Error 1.68
|
-2.2 score on a scale
Standard Error 2.21
|
-4.2 score on a scale
Standard Error 0.85
|
-3.8 score on a scale
Standard Error 0.91
|
-5.5 score on a scale
Standard Error 0.50
|
—
|
-6.8 score on a scale
Standard Error 1.23
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.4 score on a scale
Standard Error 0.86
|
-2.6 score on a scale
Standard Error 1.35
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 16
|
-4.1 score on a scale
Standard Error 1.74
|
-2.2 score on a scale
Standard Error 2.21
|
-4.3 score on a scale
Standard Error 0.87
|
-3.5 score on a scale
Standard Error 0.96
|
-5.5 score on a scale
Standard Error 0.50
|
—
|
-6.6 score on a scale
Standard Error 1.25
|
-1.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.3 score on a scale
Standard Error 0.86
|
-2.6 score on a scale
Standard Error 1.33
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 17
|
-4.5 score on a scale
Standard Error 1.81
|
-2.2 score on a scale
Standard Error 2.21
|
-4.5 score on a scale
Standard Error 0.89
|
-3.4 score on a scale
Standard Error 0.97
|
-5.5 score on a scale
Standard Error 0.50
|
—
|
-6.8 score on a scale
Standard Error 1.11
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.99
|
-2.7 score on a scale
Standard Error 1.38
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 3
|
-3.8 score on a scale
Standard Error 1.25
|
-1.6 score on a scale
Standard Error 1.64
|
-3.5 score on a scale
Standard Error 0.61
|
-2.4 score on a scale
Standard Error 0.72
|
-1.2 score on a scale
Standard Error 0.99
|
—
|
-4.6 score on a scale
Standard Error 1.73
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-2.6 score on a scale
Standard Error 0.39
|
-0.9 score on a scale
Standard Error 0.33
|
|
Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 11
|
-4.1 score on a scale
Standard Error 1.74
|
-2.2 score on a scale
Standard Error 2.21
|
-4.4 score on a scale
Standard Error 0.90
|
-4.9 score on a scale
Standard Error 0.75
|
-5.0 score on a scale
Standard Error 1.00
|
—
|
-6.3 score on a scale
Standard Error 1.42
|
-2.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.4 score on a scale
Standard Error 0.78
|
-2.2 score on a scale
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 1
|
-23.5 percent change
Standard Error 8.22
|
-16.2 percent change
Standard Error 11.84
|
-19.5 percent change
Standard Error 6.57
|
-18.3 percent change
Standard Error 8.20
|
-2.4 percent change
Standard Error 2.19
|
—
|
-44.2 percent change
Standard Error 12.54
|
16.9 percent change
Standard Error 28.60
|
-8.8 percent change
Standard Error 1.84
|
-3.4 percent change
Standard Error 2.61
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 2
|
-37.2 percent change
Standard Error 12.11
|
-20.6 percent change
Standard Error 17.45
|
-36.7 percent change
Standard Error 7.42
|
-36.5 percent change
Standard Error 9.25
|
-6.1 percent change
Standard Error 4.37
|
—
|
-59.8 percent change
Standard Error 10.80
|
29.3 percent change
Standard Error 24.62
|
-17.8 percent change
Standard Error 3.16
|
-8.4 percent change
Standard Error 4.46
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 3
|
-46.9 percent change
Standard Error 18.33
|
-25.0 percent change
Standard Error 26.41
|
-43.4 percent change
Standard Error 7.37
|
-31.5 percent change
Standard Error 9.19
|
-15.0 percent change
Standard Error 8.02
|
—
|
-67.9 percent change
Standard Error 12.89
|
25.9 percent change
Standard Error 29.39
|
-31.2 percent change
Standard Error 4.14
|
-11.2 percent change
Standard Error 5.86
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 4
|
-48.9 percent change
Standard Error 19.96
|
-20.0 percent change
Standard Error 28.76
|
-43.9 percent change
Standard Error 7.92
|
-38.4 percent change
Standard Error 9.87
|
-29.3 percent change
Standard Error 18.23
|
—
|
-71.7 percent change
Standard Error 9.93
|
8.0 percent change
Standard Error 22.65
|
-41.7 percent change
Standard Error 5.63
|
-14.5 percent change
Standard Error 7.96
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 6
|
-57.3 percent change
Standard Error 21.58
|
-23.8 percent change
Standard Error 31.10
|
-52.3 percent change
Standard Error 9.11
|
-47.9 percent change
Standard Error 11.36
|
-33.5 percent change
Standard Error 17.50
|
—
|
-81.5 percent change
Standard Error 13.07
|
7.0 percent change
Standard Error 29.80
|
-56.5 percent change
Standard Error 6.88
|
-18.7 percent change
Standard Error 9.72
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 8
|
-50.7 percent change
Standard Error 21.56
|
-19.0 percent change
Standard Error 31.07
|
-52.4 percent change
Standard Error 9.32
|
-48.8 percent change
Standard Error 11.63
|
-39.4 percent change
Standard Error 10.21
|
—
|
-85.0 percent change
Standard Error 11.76
|
7.0 percent change
Standard Error 26.80
|
-66.5 percent change
Standard Error 7.78
|
-29.0 percent change
Standard Error 11.00
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 9
|
-51.1 percent change
Standard Error 19.68
|
-19.0 percent change
Standard Error 28.35
|
-55.7 percent change
Standard Error 9.95
|
-48.6 percent change
Standard Error 11.50
|
-62.5 percent change
Standard Error 12.50
|
—
|
-85.2 percent change
Standard Error 14.00
|
4.0 percent change
Standard Error 31.91
|
-68.1 percent change
Standard Error 8.42
|
-28.5 percent change
Standard Error 11.91
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 10
|
-50.0 percent change
Standard Error 20.26
|
-27.9 percent change
Standard Error 29.19
|
-52.6 percent change
Standard Error 9.40
|
-58.7 percent change
Standard Error 10.86
|
-62.5 percent change
Standard Error 12.50
|
—
|
-86.8 percent change
Standard Error 11.34
|
-1.2 percent change
Standard Error 25.85
|
-67.0 percent change
Standard Error 8.73
|
-24.5 percent change
Standard Error 12.35
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 11
|
-50.4 percent change
Standard Error 20.87
|
-27.3 percent change
Standard Error 30.07
|
-52.8 percent change
Standard Error 9.91
|
-61.4 percent change
Standard Error 11.45
|
-62.5 percent change
Standard Error 12.50
|
—
|
-86.6 percent change
Standard Error 10.72
|
-0.4 percent change
Standard Error 24.44
|
-64.1 percent change
Standard Error 8.66
|
-24.8 percent change
Standard Error 12.25
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 12
|
-55.4 percent change
Standard Error 21.36
|
-28.2 percent change
Standard Error 30.77
|
-53.9 percent change
Standard Error 9.88
|
-53.2 percent change
Standard Error 11.42
|
-66.1 percent change
Standard Error 8.93
|
—
|
-89.0 percent change
Standard Error 8.84
|
-2.8 percent change
Standard Error 20.15
|
-62.2 percent change
Standard Error 8.85
|
-24.8 percent change
Standard Error 12.52
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 13
|
-47.2 percent change
Standard Error 22.72
|
-27.6 percent change
Standard Error 32.73
|
-53.8 percent change
Standard Error 10.04
|
-52.2 percent change
Standard Error 11.59
|
-68.8 percent change
Standard Error 6.25
|
—
|
-90.1 percent change
Standard Error 10.04
|
6.1 percent change
Standard Error 22.89
|
-64.9 percent change
Standard Error 9.22
|
-25.2 percent change
Standard Error 13.03
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 14
|
-46.8 percent change
Standard Error 20.94
|
-27.7 percent change
Standard Error 30.17
|
-55.3 percent change
Standard Error 10.15
|
-51.4 percent change
Standard Error 11.72
|
-68.8 percent change
Standard Error 6.25
|
—
|
-88.8 percent change
Standard Error 10.85
|
10.7 percent change
Standard Error 24.74
|
-65.9 percent change
Standard Error 9.17
|
-26.1 percent change
Standard Error 12.97
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 15
|
-53.6 percent change
Standard Error 20.68
|
-28.2 percent change
Standard Error 29.79
|
-50.8 percent change
Standard Error 10.54
|
-49.0 percent change
Standard Error 12.18
|
-68.8 percent change
Standard Error 6.25
|
—
|
-91.8 percent change
Standard Error 9.58
|
3.0 percent change
Standard Error 21.85
|
-63.7 percent change
Standard Error 9.87
|
-29.5 percent change
Standard Error 13.96
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 16
|
-50.0 percent change
Standard Error 21.31
|
-28.0 percent change
Standard Error 30.70
|
-51.7 percent change
Standard Error 10.86
|
-44.7 percent change
Standard Error 12.54
|
-68.8 percent change
Standard Error 6.25
|
—
|
-90.6 percent change
Standard Error 9.28
|
9.1 percent change
Standard Error 21.17
|
-62.7 percent change
Standard Error 9.81
|
-29.3 percent change
Standard Error 13.88
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 17
|
-55.0 percent change
Standard Error 23.07
|
-28.7 percent change
Standard Error 33.24
|
-54.2 percent change
Standard Error 11.00
|
-43.7 percent change
Standard Error 12.70
|
-68.8 percent change
Standard Error 6.25
|
—
|
-92.2 percent change
Standard Error 8.10
|
6.8 percent change
Standard Error 18.46
|
-58.0 percent change
Standard Error 11.35
|
-30.8 percent change
Standard Error 16.05
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 5
|
-54.7 percent change
Standard Error 23.35
|
-22.0 percent change
Standard Error 33.65
|
-51.6 percent change
Standard Error 8.70
|
-40.6 percent change
Standard Error 10.84
|
-31.1 percent change
Standard Error 20.41
|
—
|
-76.9 percent change
Standard Error 13.08
|
13.8 percent change
Standard Error 29.81
|
-53.0 percent change
Standard Error 7.11
|
-17.7 percent change
Standard Error 10.05
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 7
|
-53.6 percent change
Standard Error 24.07
|
-36.4 percent change
Standard Error 34.67
|
-54.3 percent change
Standard Error 8.98
|
-48.1 percent change
Standard Error 11.19
|
-39.4 percent change
Standard Error 10.21
|
—
|
-87.4 percent change
Standard Error 11.02
|
7.8 percent change
Standard Error 25.13
|
-60.6 percent change
Standard Error 7.48
|
-22.5 percent change
Standard Error 10.57
|
|
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Change at Week 18
|
-54.5 percent change
Standard Error 20.93
|
-28.9 percent change
Standard Error 30.15
|
-51.5 percent change
Standard Error 12.05
|
-43.7 percent change
Standard Error 13.92
|
-69.6 percent change
Standard Error 7.14
|
—
|
-92.1 percent change
Standard Error 6.42
|
4.1 percent change
Standard Error 14.63
|
-58.1 percent change
Standard Error 11.43
|
-31.1 percent change
Standard Error 16.17
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-8, 10, 12, 14, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-0.1 units on a scale
Standard Error 0.10
|
-3.2 units on a scale
Standard Error 1.09
|
-3.4 units on a scale
Standard Error 0.97
|
-2.0 units on a scale
Standard Error 1.36
|
—
|
-5.2 units on a scale
Standard Error 1.85
|
-2.2 units on a scale
Standard Error NA
1 participant in this cohort
|
-3.4 units on a scale
Standard Error 0.55
|
-0.9 units on a scale
Standard Error 0.81
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.5 units on a scale
Standard Error 1.01
|
-4.7 units on a scale
Standard Error 0.88
|
-3.0 units on a scale
Standard Error 1.86
|
—
|
-5.7 units on a scale
Standard Error 1.67
|
-3.7 units on a scale
Standard Error NA
1 participant in this cohort
|
-4.3 units on a scale
Standard Error 0.51
|
-1.6 units on a scale
Standard Error 0.99
|
|
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
|
-0.1 units on a scale
Standard Error 0.10
|
-4.7 units on a scale
Standard Error 1.05
|
-4.7 units on a scale
Standard Error 0.88
|
-3.3 units on a scale
Standard Error 1.85
|
—
|
-6.1 units on a scale
Standard Error 1.45
|
-1.4 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.3 units on a scale
Standard Error 0.57
|
-2.1 units on a scale
Standard Error 1.27
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.7 units on a scale
Standard Error 1.10
|
-4.8 units on a scale
Standard Error 1.18
|
-5.1 units on a scale
Standard Error 1.30
|
—
|
-6.3 units on a scale
Standard Error 1.37
|
-3.5 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.6 units on a scale
Standard Error 0.71
|
-3.8 units on a scale
Standard Error 1.26
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-5.0 units on a scale
Standard Error 1.00
|
-4.2 units on a scale
Standard Error 1.06
|
-5.3 units on a scale
Standard Error 1.10
|
—
|
-6.4 units on a scale
Standard Error 1.31
|
-1.4 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.8 units on a scale
Standard Error 0.75
|
-3.6 units on a scale
Standard Error 1.37
|
|
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
|
-0.1 units on a scale
Standard Error 0.05
|
-4.2 units on a scale
Standard Error 1.07
|
-4.0 units on a scale
Standard Error 1.13
|
-5.6 units on a scale
Standard Error 0.85
|
—
|
-6.6 units on a scale
Standard Error 1.12
|
-0.8 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.6 units on a scale
Standard Error 0.79
|
-3.5 units on a scale
Standard Error 1.41
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.2 units on a scale
Standard Error 1.22
|
-3.6 units on a scale
Standard Error 1.20
|
-5.6 units on a scale
Standard Error 2.40
|
—
|
-7.0 units on a scale
Standard Error 0.74
|
-0.9 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.4 units on a scale
Standard Error 0.90
|
-3.9 units on a scale
Standard Error 1.31
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-1.3 units on a scale
Standard Error 0.79
|
-2.0 units on a scale
Standard Error 0.78
|
-0.4 units on a scale
Standard Error 0.26
|
—
|
-4.0 units on a scale
Standard Error 1.61
|
-0.7 units on a scale
Standard Error NA
1 participant in this cohort
|
-1.3 units on a scale
Standard Error 0.29
|
-0.3 units on a scale
Standard Error 0.28
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-3.0 units on a scale
Standard Error 0.96
|
-2.6 units on a scale
Standard Error 0.62
|
-0.4 units on a scale
Standard Error 0.19
|
—
|
-4.4 units on a scale
Standard Error 1.80
|
-1.0 units on a scale
Standard Error NA
1 participant in this cohort
|
-2.2 units on a scale
Standard Error 0.55
|
-0.7 units on a scale
Standard Error 0.31
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-3.7 units on a scale
Standard Error 0.94
|
-3.9 units on a scale
Standard Error 0.95
|
-2.8 units on a scale
Standard Error 1.88
|
—
|
-5.3 units on a scale
Standard Error 1.66
|
-2.2 units on a scale
Standard Error NA
1 participant in this cohort
|
-4.3 units on a scale
Standard Error 0.54
|
-1.4 units on a scale
Standard Error 0.94
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.5 units on a scale
Standard Error 1.00
|
-4.2 units on a scale
Standard Error 1.07
|
-3.1 units on a scale
Standard Error 1.85
|
—
|
-5.9 units on a scale
Standard Error 1.57
|
-2.0 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.2 units on a scale
Standard Error 0.54
|
-1.9 units on a scale
Standard Error 1.05
|
|
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
Change at Week 8
|
-4.2 units on a scale
Standard Error 2.00
|
0.0 units on a scale
Standard Error 0.00
|
-4.4 units on a scale
Standard Error 1.03
|
-4.3 units on a scale
Standard Error 0.95
|
-3.3 units on a scale
Standard Error 1.85
|
—
|
-6.0 units on a scale
Standard Error 1.42
|
-1.8 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.8 units on a scale
Standard Error 0.61
|
-2.2 units on a scale
Standard Error 1.29
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.2 units on a scale
Standard Error 1.07
|
-5.8 units on a scale
Standard Error 0.58
|
-5.6 units on a scale
Standard Error 0.85
|
—
|
-6.2 units on a scale
Standard Error 1.50
|
-3.5 units on a scale
Standard Error NA
1 participant in this cohort
|
-5.9 units on a scale
Standard Error 0.66
|
-3.1 units on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-8, 10, 12, 14, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 7
|
-65.7 percent change
Standard Error 18.99
|
0.1 percent change
Standard Error 27.22
|
-55.7 percent change
Standard Error 10.97
|
-60.8 percent change
Standard Error 13.68
|
-44.3 percent change
Standard Error 21.36
|
—
|
-101.8 percent change
Standard Error 22.55
|
73.6 percent change
Standard Error 71.40
|
-64.6 percent change
Standard Error 7.89
|
-25.4 percent change
Standard Error 11.18
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 1
|
-23.6 percent change
Standard Error 13.76
|
-8.3 percent change
Standard Error 19.72
|
-15.3 percent change
Standard Error 9.17
|
-24.8 percent change
Standard Error 11.44
|
-5.3 percent change
Standard Error 1.80
|
—
|
-76.1 percent change
Standard Error 27.14
|
90.9 percent change
Standard Error 85.95
|
-15.4 percent change
Standard Error 3.19
|
-4.6 percent change
Standard Error 4.52
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 3
|
-43.3 percent change
Standard Error 19.79
|
-2.6 percent change
Standard Error 28.36
|
-37.4 percent change
Standard Error 12.12
|
-44.5 percent change
Standard Error 15.12
|
-26.2 percent change
Standard Error 8.32
|
—
|
-97.1 percent change
Standard Error 28.92
|
96.7 percent change
Standard Error 91.57
|
-40.6 percent change
Standard Error 6.26
|
-10.3 percent change
Standard Error 8.87
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 8
|
-54.1 percent change
Standard Error 22.59
|
-0.4 percent change
Standard Error 32.38
|
-52.1 percent change
Standard Error 11.11
|
-55.0 percent change
Standard Error 13.86
|
-44.3 percent change
Standard Error 21.36
|
—
|
-99.2 percent change
Standard Error 23.11
|
63.8 percent change
Standard Error 73.18
|
-70.9 percent change
Standard Error 8.44
|
-25.2 percent change
Standard Error 11.96
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 10
|
-61.6 percent change
Standard Error 20.31
|
0.7 percent change
Standard Error 29.11
|
-50.7 percent change
Standard Error 10.73
|
-72.2 percent change
Standard Error 12.39
|
-76.9 percent change
Standard Error 0.00
|
—
|
-103.9 percent change
Standard Error 22.62
|
57.5 percent change
Standard Error 71.64
|
-70.6 percent change
Standard Error 8.32
|
-36.2 percent change
Standard Error 12.71
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 12
|
-51.9 percent change
Standard Error 21.21
|
3.3 percent change
Standard Error 30.40
|
-56.3 percent change
Standard Error 12.44
|
-58.7 percent change
Standard Error 14.37
|
-69.7 percent change
Standard Error 0.00
|
—
|
-102.9 percent change
Standard Error 21.13
|
46.3 percent change
Standard Error 66.92
|
-67.6 percent change
Standard Error 8.32
|
-45.5 percent change
Standard Error 12.71
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 14
|
-44.2 percent change
Standard Error 20.40
|
4.4 percent change
Standard Error 29.24
|
-60.8 percent change
Standard Error 11.32
|
-51.2 percent change
Standard Error 13.07
|
-72.9 percent change
Standard Error 0.00
|
—
|
-103.3 percent change
Standard Error 19.74
|
64.5 percent change
Standard Error 62.52
|
-69.6 percent change
Standard Error 8.91
|
-42.5 percent change
Standard Error 13.61
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 16
|
-56.8 percent change
Standard Error 14.02
|
5.1 percent change
Standard Error 20.09
|
-49.5 percent change
Standard Error 11.91
|
-48.9 percent change
Standard Error 13.75
|
-76.9 percent change
Standard Error 0.00
|
—
|
-102.0 percent change
Standard Error 16.87
|
57.2 percent change
Standard Error 53.41
|
-68.1 percent change
Standard Error 9.43
|
-41.6 percent change
Standard Error 14.40
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 2
|
-37.4 percent change
Standard Error 19.67
|
-4.3 percent change
Standard Error 28.19
|
-34.2 percent change
Standard Error 9.66
|
-32.8 percent change
Standard Error 12.04
|
-5.1 percent change
Standard Error 3.22
|
—
|
-79.6 percent change
Standard Error 34.28
|
81.3 percent change
Standard Error 108.56
|
-24.2 percent change
Standard Error 5.50
|
-10.1 percent change
Standard Error 7.78
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 4
|
-54.9 percent change
Standard Error 19.93
|
-0.9 percent change
Standard Error 28.57
|
-44.4 percent change
Standard Error 10.57
|
-50.7 percent change
Standard Error 13.18
|
-37.3 percent change
Standard Error 12.60
|
—
|
-93.6 percent change
Standard Error 28.13
|
74.8 percent change
Standard Error 89.08
|
-52.7 percent change
Standard Error 6.55
|
-16.0 percent change
Standard Error 9.27
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 5
|
-66.3 percent change
Standard Error 21.37
|
-0.2 percent change
Standard Error 30.63
|
-54.1 percent change
Standard Error 10.84
|
-60.4 percent change
Standard Error 13.52
|
-40.0 percent change
Standard Error 15.97
|
—
|
-99.4 percent change
Standard Error 26.68
|
64.0 percent change
Standard Error 84.47
|
-52.5 percent change
Standard Error 6.54
|
-19.1 percent change
Standard Error 9.26
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 6
|
-57.2 percent change
Standard Error 22.58
|
-1.2 percent change
Standard Error 32.37
|
-53.0 percent change
Standard Error 11.31
|
-52.4 percent change
Standard Error 14.11
|
-41.6 percent change
Standard Error 17.99
|
—
|
-101.0 percent change
Standard Error 24.68
|
76.3 percent change
Standard Error 78.14
|
-63.5 percent change
Standard Error 6.90
|
-21.5 percent change
Standard Error 9.77
|
|
Percent Change From Baseline in Pruritus VAS Over Time
Change at Week 18
|
-47.8 percent change
Standard Error 14.97
|
6.8 percent change
Standard Error 21.45
|
-49.1 percent change
Standard Error 13.66
|
-45.0 percent change
Standard Error 15.77
|
-74.6 percent change
Standard Error 0.00
|
—
|
-101.3 percent change
Standard Error 9.93
|
29.5 percent change
Standard Error 31.43
|
-64.5 percent change
Standard Error 10.23
|
-46.0 percent change
Standard Error 15.63
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18Population: 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.
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).
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-4.4 units on a scale
Standard Error 1.06
|
-4.0 units on a scale
Standard Error 1.35
|
-2.3 units on a scale
Standard Error 1.20
|
—
|
-6.8 units on a scale
Standard Error 2.10
|
-4.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 units on a scale
Standard Error 1.19
|
-3.6 units on a scale
Standard Error 1.29
|
|
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
|
0.5 units on a scale
Standard Error 0.50
|
-4.5 units on a scale
Standard Error 1.27
|
-5.4 units on a scale
Standard Error 1.65
|
-7.3 units on a scale
Standard Error 4.06
|
—
|
-7.3 units on a scale
Standard Error 2.78
|
-4.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-7.7 units on a scale
Standard Error 1.05
|
-4.1 units on a scale
Standard Error 1.81
|
|
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
|
0.5 units on a scale
Standard Error 0.50
|
-6.6 units on a scale
Standard Error 1.23
|
-5.8 units on a scale
Standard Error 1.47
|
-8.0 units on a scale
Standard Error 4.16
|
—
|
-8.5 units on a scale
Standard Error 2.90
|
-7.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-8.2 units on a scale
Standard Error 1.05
|
-5.0 units on a scale
Standard Error 1.79
|
|
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
|
-0.5 units on a scale
Standard Error 0.50
|
-6.5 units on a scale
Standard Error 1.32
|
-6.8 units on a scale
Standard Error 1.23
|
-8.0 units on a scale
Standard Error 4.16
|
—
|
-8.8 units on a scale
Standard Error 2.95
|
-7.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-9.4 units on a scale
Standard Error 1.09
|
-5.0 units on a scale
Standard Error 1.75
|
|
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
|
-1.0 units on a scale
Standard Error 1.00
|
-6.6 units on a scale
Standard Error 1.50
|
-7.9 units on a scale
Standard Error 0.63
|
-12.0 units on a scale
Standard Error 2.00
|
—
|
-9.5 units on a scale
Standard Error 2.87
|
-7.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-9.4 units on a scale
Standard Error 1.46
|
-6.0 units on a scale
Standard Error 1.81
|
|
Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 16
|
-7.8 units on a scale
Standard Error 2.10
|
0.5 units on a scale
Standard Error 0.50
|
-7.1 units on a scale
Standard Error 1.77
|
-5.0 units on a scale
Standard Error 1.47
|
-11.5 units on a scale
Standard Error 2.50
|
—
|
-10.0 units on a scale
Standard Error 2.38
|
-2.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-9.6 units on a scale
Standard Error 1.48
|
-7.2 units on a scale
Standard Error 1.97
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-6.3 units on a scale
Standard Error 1.33
|
-6.3 units on a scale
Standard Error 1.04
|
-12.0 units on a scale
Standard Error 2.00
|
—
|
-9.8 units on a scale
Standard Error 2.63
|
-8.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-9.6 units on a scale
Standard Error 1.32
|
-6.3 units on a scale
Standard Error 1.71
|
|
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
|
0.0 units on a scale
Standard Error 0.00
|
-6.7 units on a scale
Standard Error 1.08
|
-6.1 units on a scale
Standard Error 1.17
|
-12.0 units on a scale
Standard Error 2.00
|
—
|
-9.5 units on a scale
Standard Error 2.87
|
-4.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-9.6 units on a scale
Standard Error 1.53
|
-6.5 units on a scale
Standard Error 1.78
|
|
Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 18
|
-6.5 units on a scale
Standard Error 2.50
|
0.5 units on a scale
Standard Error 0.50
|
-6.3 units on a scale
Standard Error 1.82
|
-4.6 units on a scale
Standard Error 1.42
|
-13.5 units on a scale
Standard Error 3.50
|
—
|
-10.0 units on a scale
Standard Error 2.38
|
-2.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-8.9 units on a scale
Standard Error 1.57
|
-7.0 units on a scale
Standard Error 1.65
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18Population: 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.
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).
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 2
|
-31.3 percent change
Standard Error 13.40
|
0.0 percent change
Standard Error 18.98
|
-24.2 percent change
Standard Error 6.00
|
-20.6 percent change
Standard Error 7.48
|
-11.8 percent change
Standard Error 8.46
|
—
|
-44.0 percent change
Standard Error 3.43
|
8.4 percent change
Standard Error 8.04
|
-25.4 percent change
Standard Error 5.38
|
-18.8 percent change
Standard Error 7.61
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 4
|
-42.7 percent change
Standard Error 9.40
|
2.4 percent change
Standard Error 13.31
|
-24.1 percent change
Standard Error 7.03
|
-29.2 percent change
Standard Error 8.77
|
-35.1 percent change
Standard Error 12.38
|
—
|
-49.1 percent change
Standard Error 2.09
|
23.0 percent change
Standard Error 4.90
|
-40.3 percent change
Standard Error 5.55
|
-20.8 percent change
Standard Error 7.85
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 6
|
-41.4 percent change
Standard Error 10.22
|
2.3 percent change
Standard Error 14.48
|
-35.9 percent change
Standard Error 6.66
|
-31.6 percent change
Standard Error 8.31
|
-38.8 percent change
Standard Error 17.46
|
—
|
-56.5 percent change
Standard Error 1.49
|
9.1 percent change
Standard Error 3.49
|
-43.3 percent change
Standard Error 5.67
|
-25.9 percent change
Standard Error 8.02
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 8
|
-37.7 percent change
Standard Error 10.85
|
-2.2 percent change
Standard Error 15.36
|
-34.4 percent change
Standard Error 6.30
|
-37.2 percent change
Standard Error 7.85
|
-38.8 percent change
Standard Error 17.46
|
—
|
-58.1 percent change
Standard Error 0.83
|
10.1 percent change
Standard Error 1.95
|
-49.1 percent change
Standard Error 5.49
|
-25.7 percent change
Standard Error 7.77
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 12
|
-33.3 percent change
Standard Error 9.21
|
-0.8 percent change
Standard Error 13.05
|
-33.5 percent change
Standard Error 6.64
|
-34.4 percent change
Standard Error 7.66
|
-58.2 percent change
Standard Error 0.00
|
—
|
-62.8 percent change
Standard Error 3.53
|
-3.4 percent change
Standard Error 8.28
|
-50.2 percent change
Standard Error 5.86
|
-31.4 percent change
Standard Error 9.00
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 14
|
-17.9 percent change
Standard Error 14.08
|
-1.1 percent change
Standard Error 19.95
|
-36.2 percent change
Standard Error 5.83
|
-33.3 percent change
Standard Error 6.74
|
-58.2 percent change
Standard Error 0.00
|
—
|
-62.1 percent change
Standard Error 3.76
|
20.2 percent change
Standard Error 8.82
|
-49.7 percent change
Standard Error 7.04
|
-33.1 percent change
Standard Error 10.81
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 16
|
-37.7 percent change
Standard Error 8.29
|
1.7 percent change
Standard Error 11.74
|
-37.0 percent change
Standard Error 8.29
|
-27.8 percent change
Standard Error 9.57
|
-55.4 percent change
Standard Error 0.00
|
—
|
-63.6 percent change
Standard Error 3.33
|
18.5 percent change
Standard Error 7.81
|
-49.9 percent change
Standard Error 7.08
|
-36.8 percent change
Standard Error 10.88
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 10
|
-40.1 percent change
Standard Error 8.46
|
-4.5 percent change
Standard Error 11.98
|
-35.2 percent change
Standard Error 6.47
|
-43.1 percent change
Standard Error 7.48
|
-58.2 percent change
Standard Error 0.00
|
—
|
-62.1 percent change
Standard Error 3.76
|
6.6 percent change
Standard Error 8.82
|
-49.1 percent change
Standard Error 6.55
|
-29.6 percent change
Standard Error 10.06
|
|
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Change at Week 18
|
-31.3 percent change
Standard Error 10.41
|
1.6 percent change
Standard Error 14.75
|
-32.9 percent change
Standard Error 8.83
|
-25.0 percent change
Standard Error 10.19
|
-64.7 percent change
Standard Error 0.00
|
—
|
-63.6 percent change
Standard Error 3.33
|
18.5 percent change
Standard Error 7.81
|
-46.6 percent change
Standard Error 7.43
|
-35.5 percent change
Standard Error 11.41
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
—
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 23.2
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
—
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 23.2
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
—
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
64.3 percentage of participants
Interval 35.1 to 87.2
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
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
Interval 6.8 to 93.2
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
64.3 percentage of participants
Interval 35.1 to 87.2
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
64.3 percentage of participants
Interval 35.1 to 87.2
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 0.6 to 80.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
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
Interval 0.6 to 80.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 0.6 to 80.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
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
Interval 6.8 to 93.2
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
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
Interval 0.6 to 80.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
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
Interval 19.4 to 99.4
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
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
Interval 19.4 to 99.4
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0.3 score on a scale
Standard Error 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.2 score on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.4 score on a scale
Standard Error 0.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Change at Week 4
|
-1.2 score on a scale
Standard Error 0.30
|
-0.2 score on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.2 score on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.1 score on a scale
Standard Error 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Change at Week 7
|
-1.1 score on a scale
Standard Error 0.30
|
-0.4 score on a scale
Standard Error 0.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Change at Week 8
|
-0.8 score on a scale
Standard Error 0.40
|
-0.1 score on a scale
Standard Error 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.1 score on a scale
Standard Error 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-0.6 score on a scale
Standard Error 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-13.3 percent change
Standard Error 13.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-10.0 percent change
Standard Error 10.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-10.0 percent change
Standard Error 10.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-6.7 percent change
Standard Error 6.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-20.0 percent change
Standard Error 20.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-6.7 percent change
Standard Error 6.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-6.7 percent change
Standard Error 6.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-23.3 percent change
Standard Error 23.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-26.7 percent change
Standard Error 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-10.0 percent change
Standard Error 10.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
-16.7 percent change
Standard Error 16.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-8, 10, 12, 14, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 4
|
-2.9 units on a scale
Standard Error 2.30
|
0.1 units on a scale
Standard Error 0.10
|
-1.5 units on a scale
Standard Error 0.80
|
-3.4 units on a scale
Standard Error 0.86
|
-2.9 units on a scale
Standard Error 1.87
|
—
|
-4.2 units on a scale
Standard Error 1.81
|
-0.1 units on a scale
Standard Error NA
1 participant in this cohort.
|
-3.7 units on a scale
Standard Error 0.62
|
-0.3 units on a scale
Standard Error 1.30
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 5
|
-3.5 units on a scale
Standard Error 2.34
|
0.1 units on a scale
Standard Error 0.10
|
-2.0 units on a scale
Standard Error 0.72
|
-3.9 units on a scale
Standard Error 0.96
|
-3.1 units on a scale
Standard Error 1.85
|
—
|
-4.4 units on a scale
Standard Error 1.75
|
-2.6 units on a scale
Standard Error NA
1 participant in this cohort.
|
-4.0 units on a scale
Standard Error 0.59
|
-1.2 units on a scale
Standard Error 1.14
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 6
|
-2.9 units on a scale
Standard Error 2.69
|
0.1 units on a scale
Standard Error 0.10
|
-2.3 units on a scale
Standard Error 0.74
|
-3.6 units on a scale
Standard Error 0.83
|
-3.1 units on a scale
Standard Error 1.85
|
—
|
-5.0 units on a scale
Standard Error 1.46
|
-1.3 units on a scale
Standard Error NA
1 participant in this cohort.
|
-4.6 units on a scale
Standard Error 0.56
|
-1.6 units on a scale
Standard Error 1.20
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 8
|
-3.3 units on a scale
Standard Error 2.48
|
0.1 units on a scale
Standard Error 0.05
|
-2.1 units on a scale
Standard Error 0.67
|
-3.8 units on a scale
Standard Error 0.91
|
-3.4 units on a scale
Standard Error 1.86
|
—
|
-5.3 units on a scale
Standard Error 1.27
|
-1.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.4 units on a scale
Standard Error 0.59
|
-2.1 units on a scale
Standard Error 1.29
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 1
|
-1.6 units on a scale
Standard Error 1.12
|
0.1 units on a scale
Standard Error 0.10
|
0.4 units on a scale
Standard Error 0.78
|
-2.1 units on a scale
Standard Error 1.17
|
-0.4 units on a scale
Standard Error 0.31
|
—
|
-2.8 units on a scale
Standard Error 1.81
|
0.1 units on a scale
Standard Error NA
1 participant in this cohort.
|
-1.2 units on a scale
Standard Error 0.25
|
-0.1 units on a scale
Standard Error 0.35
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 2
|
-3.1 units on a scale
Standard Error 1.46
|
0.1 units on a scale
Standard Error 0.10
|
-1.0 units on a scale
Standard Error 0.60
|
-2.6 units on a scale
Standard Error 0.71
|
-0.3 units on a scale
Standard Error 0.15
|
—
|
-3.4 units on a scale
Standard Error 1.98
|
0.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-2.1 units on a scale
Standard Error 0.48
|
-0.4 units on a scale
Standard Error 0.58
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 3
|
-2.4 units on a scale
Standard Error 1.86
|
0.1 units on a scale
Standard Error 0.10
|
-1.6 units on a scale
Standard Error 0.70
|
-3.6 units on a scale
Standard Error 0.95
|
-2.1 units on a scale
Standard Error 1.49
|
—
|
-4.1 units on a scale
Standard Error 1.97
|
-0.1 units on a scale
Standard Error NA
1 participant in this cohort.
|
-3.0 units on a scale
Standard Error 0.62
|
-1.0 units on a scale
Standard Error 0.75
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 7
|
-3.7 units on a scale
Standard Error 2.16
|
0.0 units on a scale
Standard Error 0.00
|
-2.1 units on a scale
Standard Error 0.67
|
-3.9 units on a scale
Standard Error 0.79
|
-3.4 units on a scale
Standard Error 1.86
|
—
|
-5.2 units on a scale
Standard Error 1.33
|
-1.0 units on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 units on a scale
Standard Error 0.58
|
-1.8 units on a scale
Standard Error 1.34
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 10
|
-3.8 units on a scale
Standard Error 2.20
|
0.1 units on a scale
Standard Error 0.10
|
-1.7 units on a scale
Standard Error 0.66
|
-5.4 units on a scale
Standard Error 0.80
|
-5.5 units on a scale
Standard Error 0.90
|
—
|
-5.3 units on a scale
Standard Error 1.29
|
-2.4 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.4 units on a scale
Standard Error 0.63
|
-3.1 units on a scale
Standard Error 1.36
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 12
|
-3.3 units on a scale
Standard Error 2.14
|
0.1 units on a scale
Standard Error 0.05
|
-1.6 units on a scale
Standard Error 0.73
|
-4.3 units on a scale
Standard Error 0.88
|
-5.3 units on a scale
Standard Error 1.15
|
—
|
-5.2 units on a scale
Standard Error 1.32
|
-2.3 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.2 units on a scale
Standard Error 0.68
|
-3.2 units on a scale
Standard Error 1.41
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 14
|
-3.0 units on a scale
Standard Error 2.36
|
0.1 units on a scale
Standard Error 0.10
|
-1.7 units on a scale
Standard Error 0.67
|
-4.9 units on a scale
Standard Error 0.72
|
-5.3 units on a scale
Standard Error 1.15
|
—
|
-5.2 units on a scale
Standard Error 1.33
|
-0.1 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.3 units on a scale
Standard Error 0.70
|
-3.0 units on a scale
Standard Error 1.49
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 16
|
-3.5 units on a scale
Standard Error 2.14
|
0.1 units on a scale
Standard Error 0.10
|
-1.5 units on a scale
Standard Error 0.78
|
-4.0 units on a scale
Standard Error 1.02
|
-5.6 units on a scale
Standard Error 0.85
|
—
|
-5.4 units on a scale
Standard Error 1.23
|
-0.4 units on a scale
Standard Error NA
1 participant in this cohort.
|
-5.1 units on a scale
Standard Error 0.75
|
-2.8 units on a scale
Standard Error 1.51
|
|
Change From Baseline in Sleep Loss VAS Over Time
Change at Week 18
|
-2.9 units on a scale
Standard Error 2.28
|
0.1 units on a scale
Standard Error 0.05
|
-1.4 units on a scale
Standard Error 0.84
|
-3.1 units on a scale
Standard Error 1.03
|
-5.7 units on a scale
Standard Error 2.25
|
—
|
-5.6 units on a scale
Standard Error 1.11
|
-0.6 units on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 units on a scale
Standard Error 0.90
|
-3.3 units on a scale
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-8, 10, 12, 14, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 1
|
-25.1 percent change
Standard Error 20.89
|
2.9 percent change
Standard Error 31.37
|
484.2 percent change
Standard Error 401.19
|
108.2 percent change
Standard Error 483.26
|
-5.1 percent change
Standard Error 1.04
|
—
|
-45.5 percent change
Standard Error 27.70
|
22.2 percent change
Standard Error 62.96
|
-12.7 percent change
Standard Error 5.20
|
-0.3 percent change
Standard Error 7.56
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 18
|
-47.3 percent change
Standard Error 11.94
|
27.7 percent change
Standard Error 17.93
|
-23.3 percent change
Standard Error 15.15
|
-56.1 percent change
Standard Error 16.79
|
-74.7 percent change
Standard Error 0.00
|
—
|
-89.9 percent change
Standard Error 11.26
|
-9.8 percent change
Standard Error 25.59
|
-61.6 percent change
Standard Error 11.11
|
-43.6 percent change
Standard Error 17.22
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 4
|
-46.8 percent change
Standard Error 28.92
|
22.4 percent change
Standard Error 43.43
|
244.8 percent change
Standard Error 239.53
|
15.4 percent change
Standard Error 288.53
|
-38.5 percent change
Standard Error 13.99
|
—
|
-67.0 percent change
Standard Error 28.94
|
4.2 percent change
Standard Error 65.78
|
-37.9 percent change
Standard Error 11.30
|
2.4 percent change
Standard Error 16.42
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 2
|
-49.5 percent change
Standard Error 20.04
|
9.9 percent change
Standard Error 30.10
|
12.4 percent change
Standard Error 30.69
|
-27.1 percent change
Standard Error 36.97
|
-4.1 percent change
Standard Error 2.48
|
—
|
-55.1 percent change
Standard Error 29.83
|
22.1 percent change
Standard Error 67.80
|
-23.9 percent change
Standard Error 8.20
|
-5.1 percent change
Standard Error 11.91
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 5
|
-56.5 percent change
Standard Error 27.85
|
22.2 percent change
Standard Error 41.82
|
8.2 percent change
Standard Error 50.36
|
-52.6 percent change
Standard Error 60.66
|
-41.1 percent change
Standard Error 17.26
|
—
|
-70.4 percent change
Standard Error 28.63
|
-28.9 percent change
Standard Error 65.09
|
-47.2 percent change
Standard Error 9.43
|
-15.7 percent change
Standard Error 13.70
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 3
|
-38.1 percent change
Standard Error 25.21
|
17.1 percent change
Standard Error 37.85
|
9.9 percent change
Standard Error 44.29
|
-47.7 percent change
Standard Error 53.35
|
-27.6 percent change
Standard Error 7.82
|
—
|
-66.1 percent change
Standard Error 33.17
|
0.8 percent change
Standard Error 75.41
|
-34.7 percent change
Standard Error 7.29
|
-16.9 percent change
Standard Error 10.59
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 6
|
-47.6 percent change
Standard Error 34.25
|
27.1 percent change
Standard Error 51.43
|
-39.8 percent change
Standard Error 14.56
|
-61.6 percent change
Standard Error 17.54
|
-41.6 percent change
Standard Error 17.91
|
—
|
-79.2 percent change
Standard Error 21.45
|
-15.2 percent change
Standard Error 48.76
|
-59.4 percent change
Standard Error 8.54
|
-21.7 percent change
Standard Error 12.42
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 7
|
-60.0 percent change
Standard Error 22.57
|
19.5 percent change
Standard Error 33.89
|
-17.8 percent change
Standard Error 29.08
|
-61.5 percent change
Standard Error 35.03
|
-45.3 percent change
Standard Error 22.49
|
—
|
-83.1 percent change
Standard Error 18.68
|
-14.4 percent change
Standard Error 42.45
|
-62.3 percent change
Standard Error 10.19
|
-24.3 percent change
Standard Error 14.80
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 8
|
-54.0 percent change
Standard Error 29.23
|
24.2 percent change
Standard Error 43.90
|
-26.8 percent change
Standard Error 24.06
|
-58.4 percent change
Standard Error 28.98
|
-45.3 percent change
Standard Error 22.49
|
—
|
-83.9 percent change
Standard Error 17.07
|
-14.3 percent change
Standard Error 38.81
|
-69.3 percent change
Standard Error 9.15
|
-29.0 percent change
Standard Error 13.29
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 10
|
-60.3 percent change
Standard Error 23.36
|
20.9 percent change
Standard Error 35.07
|
-43.8 percent change
Standard Error 8.58
|
-86.7 percent change
Standard Error 9.51
|
-75.0 percent change
Standard Error 0.00
|
—
|
-84.2 percent change
Standard Error 17.92
|
-31.1 percent change
Standard Error 40.73
|
-68.2 percent change
Standard Error 8.29
|
-39.9 percent change
Standard Error 12.85
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 12
|
-53.6 percent change
Standard Error 13.58
|
23.7 percent change
Standard Error 20.39
|
45.6 percent change
Standard Error 82.52
|
-43.2 percent change
Standard Error 91.47
|
-71.1 percent change
Standard Error 0.00
|
—
|
-83.4 percent change
Standard Error 18.87
|
-30.2 percent change
Standard Error 42.89
|
-66.1 percent change
Standard Error 8.84
|
-41.9 percent change
Standard Error 13.71
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 14
|
-49.5 percent change
Standard Error 19.46
|
27.2 percent change
Standard Error 29.21
|
-30.1 percent change
Standard Error 14.43
|
-75.6 percent change
Standard Error 15.99
|
-71.1 percent change
Standard Error 0.00
|
—
|
-83.0 percent change
Standard Error 19.35
|
-6.5 percent change
Standard Error 43.97
|
-68.6 percent change
Standard Error 9.28
|
-38.0 percent change
Standard Error 14.39
|
|
Percent Change From Baseline in Sleep Loss VAS Over Time
Change at Week 16
|
-57.0 percent change
Standard Error 17.00
|
22.9 percent change
Standard Error 25.53
|
-34.4 percent change
Standard Error 15.61
|
-69.0 percent change
Standard Error 17.30
|
-75.7 percent change
Standard Error 0.00
|
—
|
-85.9 percent change
Standard Error 16.02
|
-8.9 percent change
Standard Error 36.40
|
-66.0 percent change
Standard Error 9.77
|
-36.7 percent change
Standard Error 15.16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.6 score on a scale
Standard Error 0.59
|
-2.9 score on a scale
Standard Error 0.70
|
-1.6 score on a scale
Standard Error 0.87
|
—
|
-4.6 score on a scale
Standard Error 2.10
|
-1.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-2.4 score on a scale
Standard Error 0.56
|
-0.8 score on a scale
Standard Error 0.42
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-2.7 score on a scale
Standard Error 0.72
|
-2.9 score on a scale
Standard Error 0.82
|
-2.5 score on a scale
Standard Error 1.57
|
—
|
-4.8 score on a scale
Standard Error 1.91
|
-2.1 score on a scale
Standard Error NA
1 participant in this cohort.
|
-3.1 score on a scale
Standard Error 0.55
|
-1.0 score on a scale
Standard Error 0.70
|
|
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
|
-0.4 score on a scale
Standard Error 0.43
|
-3.0 score on a scale
Standard Error 0.76
|
-3.0 score on a scale
Standard Error 0.71
|
-2.9 score on a scale
Standard Error 1.64
|
—
|
-5.2 score on a scale
Standard Error 1.95
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.1 score on a scale
Standard Error 0.72
|
-1.5 score on a scale
Standard Error 0.89
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-3.0 score on a scale
Standard Error 0.69
|
-3.8 score on a scale
Standard Error 0.71
|
-3.1 score on a scale
Standard Error 1.61
|
—
|
-5.5 score on a scale
Standard Error 1.82
|
-2.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.4 score on a scale
Standard Error 0.69
|
-1.4 score on a scale
Standard Error 0.90
|
|
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
|
-0.2 score on a scale
Standard Error 0.21
|
-3.0 score on a scale
Standard Error 0.65
|
-3.7 score on a scale
Standard Error 0.75
|
-3.6 score on a scale
Standard Error 1.65
|
—
|
-5.6 score on a scale
Standard Error 1.76
|
-2.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.8 score on a scale
Standard Error 0.72
|
-1.8 score on a scale
Standard Error 1.08
|
|
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
|
-0.3 score on a scale
Standard Error 0.29
|
-3.2 score on a scale
Standard Error 0.64
|
-2.9 score on a scale
Standard Error 0.81
|
-3.6 score on a scale
Standard Error 1.65
|
—
|
-5.4 score on a scale
Standard Error 1.94
|
-3.3 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.2 score on a scale
Standard Error 0.70
|
-2.1 score on a scale
Standard Error 1.21
|
|
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
|
0.7 score on a scale
Standard Error 0.71
|
-2.9 score on a scale
Standard Error 0.69
|
-3.7 score on a scale
Standard Error 0.65
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.4 score on a scale
Standard Error 1.88
|
-3.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.3 score on a scale
Standard Error 0.70
|
-2.4 score on a scale
Standard Error 1.27
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.6 score on a scale
Standard Error 0.65
|
-4.5 score on a scale
Standard Error 0.55
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.6 score on a scale
Standard Error 1.69
|
-3.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.2 score on a scale
Standard Error 0.77
|
-2.4 score on a scale
Standard Error 1.21
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.6 score on a scale
Standard Error 0.76
|
-4.6 score on a scale
Standard Error 0.69
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.7 score on a scale
Standard Error 1.61
|
-3.1 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.77
|
-2.4 score on a scale
Standard Error 1.20
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.8 score on a scale
Standard Error 0.68
|
-3.8 score on a scale
Standard Error 0.91
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-6.0 score on a scale
Standard Error 1.43
|
-1.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 score on a scale
Standard Error 0.81
|
-2.7 score on a scale
Standard Error 1.32
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.5 score on a scale
Standard Error 0.73
|
-4.1 score on a scale
Standard Error 0.71
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.9 score on a scale
Standard Error 1.50
|
-2.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 score on a scale
Standard Error 0.78
|
-2.5 score on a scale
Standard Error 1.17
|
|
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 1.90
|
-0.5 score on a scale
Standard Error 0.50
|
-2.5 score on a scale
Standard Error 0.65
|
-4.3 score on a scale
Standard Error 0.73
|
-5.6 score on a scale
Standard Error 0.43
|
—
|
-5.9 score on a scale
Standard Error 1.53
|
-1.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.80
|
-2.5 score on a scale
Standard Error 1.18
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.8 score on a scale
Standard Error 0.65
|
-4.3 score on a scale
Standard Error 0.78
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-5.8 score on a scale
Standard Error 1.58
|
-2.1 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.1 score on a scale
Standard Error 0.78
|
-2.6 score on a scale
Standard Error 1.20
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.6 score on a scale
Standard Error 0.61
|
-4.1 score on a scale
Standard Error 0.73
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-6.0 score on a scale
Standard Error 1.45
|
-2.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.83
|
-2.8 score on a scale
Standard Error 1.35
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.7 score on a scale
Standard Error 0.64
|
-3.5 score on a scale
Standard Error 0.85
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-6.2 score on a scale
Standard Error 1.32
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.6 score on a scale
Standard Error 0.97
|
-3.0 score on a scale
Standard Error 1.37
|
|
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
|
-0.3 score on a scale
Standard Error 0.29
|
-0.6 score on a scale
Standard Error 0.44
|
-1.7 score on a scale
Standard Error 0.40
|
-0.3 score on a scale
Standard Error 0.08
|
—
|
-3.0 score on a scale
Standard Error 1.31
|
-1.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-0.7 score on a scale
Standard Error 0.16
|
0.0 score on a scale
Standard Error 0.24
|
|
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
|
-0.4 score on a scale
Standard Error 0.43
|
-2.0 score on a scale
Standard Error 0.52
|
-3.1 score on a scale
Standard Error 0.57
|
-0.9 score on a scale
Standard Error 0.30
|
—
|
-4.3 score on a scale
Standard Error 1.96
|
-1.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-1.3 score on a scale
Standard Error 0.26
|
-0.6 score on a scale
Standard Error 0.35
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.8 score on a scale
Standard Error 0.72
|
-3.6 score on a scale
Standard Error 0.92
|
-5.7 score on a scale
Standard Error 0.43
|
—
|
-6.2 score on a scale
Standard Error 1.32
|
-1.3 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.6 score on a scale
Standard Error 0.98
|
-3.0 score on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-36.4 percent change
Standard Error 32.59
|
-46.0 percent change
Standard Error 11.47
|
-50.4 percent change
Standard Error 13.80
|
-37.2 percent change
Standard Error 28.02
|
—
|
-73.1 percent change
Standard Error 23.65
|
-15.4 percent change
Standard Error 49.24
|
-48.4 percent change
Standard Error 7.51
|
-20.8 percent change
Standard Error 10.78
|
|
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Change at Week 8
|
-51.9 percent change
Standard Error 21.00
|
-25.8 percent change
Standard Error 30.00
|
-54.1 percent change
Standard Error 8.75
|
-47.9 percent change
Standard Error 10.52
|
-46.3 percent change
Standard Error 23.22
|
—
|
-77.0 percent change
Standard Error 28.52
|
-38.6 percent change
Standard Error 59.36
|
-63.2 percent change
Standard Error 8.55
|
-27.5 percent change
Standard Error 12.29
|
|
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
|
-43.1 percent change
Standard Error 32.26
|
-45.5 percent change
Standard Error 7.86
|
-69.4 percent change
Standard Error 8.70
|
-66.9 percent change
Standard Error 0.00
|
—
|
-80.6 percent change
Standard Error 23.28
|
-35.5 percent change
Standard Error 48.46
|
-62.0 percent change
Standard Error 8.70
|
-31.5 percent change
Standard Error 12.50
|
|
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
|
-43.1 percent change
Standard Error 35.55
|
-43.2 percent change
Standard Error 9.82
|
-69.8 percent change
Standard Error 10.86
|
-66.9 percent change
Standard Error 0.00
|
—
|
-82.1 percent change
Standard Error 21.38
|
-37.1 percent change
Standard Error 44.50
|
-58.9 percent change
Standard Error 8.47
|
-33.2 percent change
Standard Error 12.17
|
|
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
|
-43.7 percent change
Standard Error 37.59
|
-43.5 percent change
Standard Error 9.52
|
-68.2 percent change
Standard Error 10.53
|
-72.8 percent change
Standard Error 0.00
|
—
|
-84.6 percent change
Standard Error 19.01
|
-21.9 percent change
Standard Error 39.57
|
-60.6 percent change
Standard Error 9.18
|
-34.1 percent change
Standard Error 13.19
|
|
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
|
-43.7 percent change
Standard Error 36.52
|
-47.8 percent change
Standard Error 10.02
|
-64.3 percent change
Standard Error 11.08
|
-73.8 percent change
Standard Error 0.00
|
—
|
-86.7 percent change
Standard Error 16.48
|
-21.8 percent change
Standard Error 34.30
|
-58.9 percent change
Standard Error 9.71
|
-37.0 percent change
Standard Error 13.95
|
|
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
|
-34.9 percent change
Standard Error 19.03
|
-31.2 percent change
Standard Error 7.80
|
-48.7 percent change
Standard Error 9.38
|
-10.9 percent change
Standard Error 5.13
|
—
|
-59.3 percent change
Standard Error 23.10
|
-0.5 percent change
Standard Error 48.09
|
-15.0 percent change
Standard Error 3.50
|
-9.3 percent change
Standard Error 5.03
|
|
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
|
-40.9 percent change
Standard Error 28.80
|
-42.1 percent change
Standard Error 8.81
|
-48.7 percent change
Standard Error 10.60
|
-20.0 percent change
Standard Error 15.28
|
—
|
-64.8 percent change
Standard Error 24.87
|
-6.2 percent change
Standard Error 51.77
|
-27.6 percent change
Standard Error 6.38
|
-11.2 percent change
Standard Error 9.16
|
|
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
|
-19.4 percent change
Standard Error 27.88
|
-50.5 percent change
Standard Error 8.27
|
-61.5 percent change
Standard Error 9.95
|
-46.3 percent change
Standard Error 23.22
|
—
|
-80.0 percent change
Standard Error 24.71
|
-30.3 percent change
Standard Error 51.45
|
-57.2 percent change
Standard Error 8.21
|
-24.5 percent change
Standard Error 11.79
|
|
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Change at Week 18
|
-61.1 percent change
Standard Error 24.70
|
-43.4 percent change
Standard Error 35.29
|
-48.1 percent change
Standard Error 10.22
|
-61.9 percent change
Standard Error 11.30
|
-74.7 percent change
Standard Error 0.00
|
—
|
-89.3 percent change
Standard Error 13.31
|
-15.1 percent change
Standard Error 27.70
|
-53.4 percent change
Standard Error 11.61
|
-41.8 percent change
Standard Error 16.68
|
|
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Change at Week 9
|
-52.4 percent change
Standard Error 10.60
|
55.9 percent change
Standard Error 15.15
|
-50.6 percent change
Standard Error 8.32
|
-60.6 percent change
Standard Error 9.20
|
-66.9 percent change
Standard Error 0.00
|
—
|
-78.0 percent change
Standard Error 27.25
|
-40.3 percent change
Standard Error 56.72
|
-64.3 percent change
Standard Error 8.48
|
-32.3 percent change
Standard Error 12.17
|
|
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
|
-44.0 percent change
Standard Error 36.83
|
-49.4 percent change
Standard Error 9.01
|
-68.9 percent change
Standard Error 9.97
|
-73.8 percent change
Standard Error 0.00
|
—
|
-83.6 percent change
Standard Error 20.28
|
-25.2 percent change
Standard Error 42.21
|
-61.7 percent change
Standard Error 9.25
|
-34.1 percent change
Standard Error 13.28
|
|
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
|
-43.1 percent change
Standard Error 34.20
|
-43.4 percent change
Standard Error 10.02
|
-64.0 percent change
Standard Error 11.08
|
-66.9 percent change
Standard Error 0.00
|
—
|
-85.2 percent change
Standard Error 18.38
|
-30.2 percent change
Standard Error 38.26
|
-58.5 percent change
Standard Error 8.78
|
-33.7 percent change
Standard Error 12.60
|
|
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
|
-43.3 percent change
Standard Error 34.96
|
-44.1 percent change
Standard Error 8.74
|
-67.0 percent change
Standard Error 9.67
|
-73.8 percent change
Standard Error 0.00
|
—
|
-86.2 percent change
Standard Error 17.11
|
-28.5 percent change
Standard Error 35.62
|
-60.2 percent change
Standard Error 9.90
|
-38.3 percent change
Standard Error 14.22
|
|
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
|
-43.6 percent change
Standard Error 38.41
|
-45.1 percent change
Standard Error 9.46
|
-60.3 percent change
Standard Error 10.47
|
-73.8 percent change
Standard Error 0.00
|
—
|
-89.3 percent change
Standard Error 13.31
|
-16.8 percent change
Standard Error 27.70
|
-53.7 percent change
Standard Error 11.52
|
-41.2 percent change
Standard Error 16.54
|
|
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
|
-1.4 percent change
Standard Error 22.72
|
-43.3 percent change
Standard Error 10.71
|
-50.3 percent change
Standard Error 12.88
|
-31.4 percent change
Standard Error 27.58
|
—
|
-67.6 percent change
Standard Error 21.14
|
-14.2 percent change
Standard Error 44.00
|
-36.3 percent change
Standard Error 6.64
|
-12.2 percent change
Standard Error 9.53
|
|
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
|
-22.2 percent change
Standard Error 13.83
|
-4.9 percent change
Standard Error 8.21
|
-26.6 percent change
Standard Error 9.88
|
-3.6 percent change
Standard Error 1.17
|
—
|
-42.9 percent change
Standard Error 17.69
|
-7.4 percent change
Standard Error 36.83
|
-9.3 percent change
Standard Error 2.32
|
1.2 percent change
Standard Error 3.33
|
|
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
|
-42.1 percent change
Standard Error 30.52
|
-47.5 percent change
Standard Error 9.49
|
-60.6 percent change
Standard Error 11.42
|
-39.8 percent change
Standard Error 26.65
|
—
|
-79.0 percent change
Standard Error 25.98
|
-30.3 percent change
Standard Error 54.08
|
-52.7 percent change
Standard Error 7.40
|
-19.0 percent change
Standard Error 10.63
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-0.3 score on a scale
Standard Error 0.29
|
-0.2 score on a scale
Standard Error 0.33
|
-1.6 score on a scale
Standard Error 0.43
|
-0.2 score on a scale
Standard Error 0.17
|
—
|
-2.6 score on a scale
Standard Error 1.26
|
-1.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-0.6 score on a scale
Standard Error 0.20
|
-0.3 score on a scale
Standard Error 0.19
|
|
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
|
-0.4 score on a scale
Standard Error 0.43
|
-1.7 score on a scale
Standard Error 0.56
|
-2.7 score on a scale
Standard Error 0.60
|
-0.7 score on a scale
Standard Error 0.41
|
—
|
-3.7 score on a scale
Standard Error 1.75
|
-0.7 score on a scale
Standard Error NA
1 participant in this cohort.
|
-1.1 score on a scale
Standard Error 0.30
|
-0.4 score on a scale
Standard Error 0.29
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-1.9 score on a scale
Standard Error 0.54
|
-2.7 score on a scale
Standard Error 0.62
|
-1.5 score on a scale
Standard Error 1.02
|
—
|
-4.2 score on a scale
Standard Error 1.98
|
-1.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-2.0 score on a scale
Standard Error 0.52
|
-0.5 score on a scale
Standard Error 0.42
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-2.0 score on a scale
Standard Error 0.65
|
-2.7 score on a scale
Standard Error 0.93
|
-2.3 score on a scale
Standard Error 1.67
|
—
|
-4.4 score on a scale
Standard Error 1.78
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-2.8 score on a scale
Standard Error 0.59
|
-0.9 score on a scale
Standard Error 0.64
|
|
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
|
-0.4 score on a scale
Standard Error 0.43
|
-2.3 score on a scale
Standard Error 0.68
|
-2.8 score on a scale
Standard Error 0.73
|
-2.8 score on a scale
Standard Error 1.75
|
—
|
-4.4 score on a scale
Standard Error 1.61
|
-1.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-3.5 score on a scale
Standard Error 0.75
|
-1.2 score on a scale
Standard Error 0.91
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.4 score on a scale
Standard Error 0.69
|
-3.7 score on a scale
Standard Error 0.64
|
-3.0 score on a scale
Standard Error 1.73
|
—
|
-5.2 score on a scale
Standard Error 1.53
|
-2.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-3.8 score on a scale
Standard Error 0.70
|
-1.1 score on a scale
Standard Error 0.95
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-1.9 score on a scale
Standard Error 0.65
|
-4.9 score on a scale
Standard Error 0.71
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.7 score on a scale
Standard Error 1.21
|
-2.6 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.2 score on a scale
Standard Error 0.74
|
-1.9 score on a scale
Standard Error 1.29
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.0 score on a scale
Standard Error 0.72
|
-4.9 score on a scale
Standard Error 0.77
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.7 score on a scale
Standard Error 1.21
|
-2.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 score on a scale
Standard Error 0.78
|
-2.0 score on a scale
Standard Error 1.25
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-1.6 score on a scale
Standard Error 0.80
|
-4.4 score on a scale
Standard Error 0.83
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.7 score on a scale
Standard Error 1.21
|
-2.7 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.8 score on a scale
Standard Error 0.80
|
-2.0 score on a scale
Standard Error 1.24
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.0 score on a scale
Standard Error 0.62
|
-4.3 score on a scale
Standard Error 0.94
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-5.5 score on a scale
Standard Error 1.30
|
-1.9 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.77
|
-5.0 score on a scale
Standard Error 0.81
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.3 score on a scale
Standard Error 0.74
|
-3.6 score on a scale
Standard Error 1.00
|
-5.7 score on a scale
Standard Error 0.43
|
—
|
-5.7 score on a scale
Standard Error 1.21
|
-1.3 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.6 score on a scale
Standard Error 0.96
|
-2.5 score on a scale
Standard Error 1.29
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-1.9 score on a scale
Standard Error 0.72
|
-4.6 score on a scale
Standard Error 0.85
|
-5.6 score on a scale
Standard Error 0.43
|
—
|
-5.6 score on a scale
Standard Error 1.24
|
-1.7 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.80
|
-2.1 score on a scale
Standard Error 1.24
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.1 score on a scale
Standard Error 0.62
|
-4.1 score on a scale
Standard Error 0.89
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-5.7 score on a scale
Standard Error 1.22
|
-2.1 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.81
|
-2.3 score on a scale
Standard Error 1.27
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.5 score on a scale
Standard Error 0.70
|
-3.6 score on a scale
Standard Error 1.01
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-5.8 score on a scale
Standard Error 1.19
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.9 score on a scale
Standard Error 0.80
|
-2.2 score on a scale
Standard Error 1.25
|
|
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
|
-0.5 score on a scale
Standard Error 0.50
|
-2.3 score on a scale
Standard Error 0.66
|
-3.7 score on a scale
Standard Error 0.98
|
-5.6 score on a scale
Standard Error 0.36
|
—
|
-5.7 score on a scale
Standard Error 1.21
|
-1.4 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.6 score on a scale
Standard Error 0.95
|
-2.5 score on a scale
Standard Error 1.29
|
|
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
|
-0.2 score on a scale
Standard Error 0.21
|
-2.4 score on a scale
Standard Error 0.65
|
-3.6 score on a scale
Standard Error 0.79
|
-3.4 score on a scale
Standard Error 1.78
|
—
|
-5.3 score on a scale
Standard Error 1.43
|
-2.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.2 score on a scale
Standard Error 0.71
|
-1.5 score on a scale
Standard Error 1.10
|
|
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
|
-0.3 score on a scale
Standard Error 0.29
|
-2.5 score on a scale
Standard Error 0.67
|
-3.6 score on a scale
Standard Error 0.89
|
-3.4 score on a scale
Standard Error 1.78
|
—
|
-5.6 score on a scale
Standard Error 1.24
|
-3.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-4.7 score on a scale
Standard Error 0.72
|
-1.8 score on a scale
Standard Error 1.23
|
|
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
|
0.7 score on a scale
Standard Error 0.71
|
-2.3 score on a scale
Standard Error 0.69
|
-4.1 score on a scale
Standard Error 0.78
|
-5.1 score on a scale
Standard Error 0.86
|
—
|
-5.6 score on a scale
Standard Error 1.28
|
-3.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-5.0 score on a scale
Standard Error 0.70
|
-2.0 score on a scale
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-28.7 percent change
Standard Error 45.50
|
-2.6 percent change
Standard Error 5.75
|
-26.3 percent change
Standard Error 7.18
|
-3.0 percent change
Standard Error 2.92
|
—
|
-40.7 percent change
Standard Error 17.63
|
-1.4 percent change
Standard Error 38.74
|
-6.7 percent change
Standard Error 2.75
|
-4.9 percent change
Standard Error 3.91
|
|
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
|
-50.4 percent change
Standard Error 67.03
|
-40.9 percent change
Standard Error 8.43
|
-62.7 percent change
Standard Error 10.54
|
-38.1 percent change
Standard Error 30.62
|
—
|
-80.2 percent change
Standard Error 22.99
|
-32.7 percent change
Standard Error 50.51
|
-46.7 percent change
Standard Error 7.82
|
-13.0 percent change
Standard Error 11.12
|
|
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
|
66.0 percent change
Standard Error 22.57
|
-42.2 percent change
Standard Error 8.76
|
-66.6 percent change
Standard Error 10.13
|
-66.9 percent change
Standard Error 0.00
|
—
|
-86.2 percent change
Standard Error 15.97
|
-37.3 percent change
Standard Error 35.08
|
-63.6 percent change
Standard Error 9.13
|
-25.5 percent change
Standard Error 12.99
|
|
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
|
-50.1 percent change
Standard Error 59.26
|
-37.4 percent change
Standard Error 8.65
|
-76.4 percent change
Standard Error 10.00
|
-66.9 percent change
Standard Error 0.00
|
—
|
-88.4 percent change
Standard Error 13.41
|
-31.9 percent change
Standard Error 29.47
|
-65.9 percent change
Standard Error 9.22
|
-25.1 percent change
Standard Error 13.11
|
|
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
|
-49.7 percent change
Standard Error 50.13
|
-44.1 percent change
Standard Error 10.40
|
-64.0 percent change
Standard Error 12.02
|
-73.8 percent change
Standard Error 0.00
|
—
|
-89.0 percent change
Standard Error 12.77
|
-19.1 percent change
Standard Error 28.06
|
-63.6 percent change
Standard Error 10.16
|
-29.4 percent change
Standard Error 14.45
|
|
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
|
-49.4 percent change
Standard Error 45.20
|
-42.8 percent change
Standard Error 10.42
|
-64.7 percent change
Standard Error 12.04
|
-74.7 percent change
Standard Error 0.00
|
—
|
-88.4 percent change
Standard Error 13.41
|
-17.6 percent change
Standard Error 29.47
|
-58.7 percent change
Standard Error 12.25
|
-34.7 percent change
Standard Error 17.43
|
|
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
|
-42.6 percent change
Standard Error 49.24
|
-28.7 percent change
Standard Error 8.26
|
-45.6 percent change
Standard Error 10.32
|
-9.2 percent change
Standard Error 7.29
|
—
|
-56.7 percent change
Standard Error 24.07
|
6.8 percent change
Standard Error 52.89
|
-12.4 percent change
Standard Error 3.67
|
-6.0 percent change
Standard Error 5.22
|
|
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
|
-49.7 percent change
Standard Error 55.57
|
-33.4 percent change
Standard Error 7.94
|
-47.2 percent change
Standard Error 9.92
|
-18.9 percent change
Standard Error 17.50
|
—
|
-64.4 percent change
Standard Error 26.92
|
6.3 percent change
Standard Error 59.14
|
-22.7 percent change
Standard Error 6.03
|
-7.1 percent change
Standard Error 8.58
|
|
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
|
-2.2 percent change
Standard Error 44.09
|
-34.6 percent change
Standard Error 10.18
|
-47.9 percent change
Standard Error 12.72
|
-29.8 percent change
Standard Error 28.43
|
—
|
-67.2 percent change
Standard Error 22.95
|
-6.6 percent change
Standard Error 50.42
|
-34.4 percent change
Standard Error 6.75
|
-11.7 percent change
Standard Error 9.60
|
|
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
|
-43.4 percent change
Standard Error 60.51
|
-38.4 percent change
Standard Error 9.11
|
-50.7 percent change
Standard Error 11.38
|
-35.5 percent change
Standard Error 30.62
|
—
|
-67.3 percent change
Standard Error 23.31
|
-16.9 percent change
Standard Error 51.21
|
-43.0 percent change
Standard Error 7.95
|
-15.9 percent change
Standard Error 11.31
|
|
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
|
-22.9 percent change
Standard Error 52.41
|
-42.4 percent change
Standard Error 8.45
|
-61.6 percent change
Standard Error 10.55
|
-44.6 percent change
Standard Error 30.62
|
—
|
-82.4 percent change
Standard Error 20.44
|
-27.3 percent change
Standard Error 44.90
|
-52.0 percent change
Standard Error 8.41
|
-19.4 percent change
Standard Error 11.96
|
|
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
|
-29.9 percent change
Standard Error 57.65
|
-43.4 percent change
Standard Error 8.98
|
-60.7 percent change
Standard Error 11.22
|
-44.6 percent change
Standard Error 30.62
|
—
|
-87.3 percent change
Standard Error 14.69
|
-37.0 percent change
Standard Error 32.27
|
-59.5 percent change
Standard Error 8.96
|
-23.1 percent change
Standard Error 12.75
|
|
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
|
-49.4 percent change
Standard Error 44.11
|
-37.1 percent change
Standard Error 9.54
|
-76.5 percent change
Standard Error 11.03
|
-66.9 percent change
Standard Error 0.00
|
—
|
-88.4 percent change
Standard Error 13.41
|
-35.1 percent change
Standard Error 29.47
|
-61.1 percent change
Standard Error 9.12
|
-26.1 percent change
Standard Error 12.97
|
|
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
|
-49.7 percent change
Standard Error 49.49
|
-30.9 percent change
Standard Error 11.35
|
-70.1 percent change
Standard Error 13.12
|
-66.9 percent change
Standard Error 0.00
|
—
|
-88.4 percent change
Standard Error 13.41
|
-33.5 percent change
Standard Error 29.47
|
-60.2 percent change
Standard Error 9.58
|
-27.0 percent change
Standard Error 13.63
|
|
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
|
-49.7 percent change
Standard Error 50.36
|
-35.9 percent change
Standard Error 10.59
|
-74.7 percent change
Standard Error 12.24
|
-72.8 percent change
Standard Error 0.00
|
—
|
-87.3 percent change
Standard Error 14.69
|
-22.7 percent change
Standard Error 32.27
|
-63.9 percent change
Standard Error 9.92
|
-28.4 percent change
Standard Error 14.11
|
|
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Change at Week 14
|
-20.4 percent change
Standard Error 42.00
|
-50.3 percent change
Standard Error 59.44
|
-38.2 percent change
Standard Error 9.62
|
-71.9 percent change
Standard Error 11.12
|
-73.8 percent change
Standard Error 0.00
|
—
|
-85.7 percent change
Standard Error 16.60
|
-24.8 percent change
Standard Error 36.48
|
-64.9 percent change
Standard Error 9.77
|
-29.3 percent change
Standard Error 13.90
|
|
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Change at Week 15
|
-25.9 percent change
Standard Error 37.20
|
-49.9 percent change
Standard Error 52.64
|
-38.6 percent change
Standard Error 9.08
|
-69.7 percent change
Standard Error 10.50
|
-73.8 percent change
Standard Error 0.00
|
—
|
-87.9 percent change
Standard Error 14.05
|
-27.3 percent change
Standard Error 30.87
|
-63.9 percent change
Standard Error 10.34
|
-31.3 percent change
Standard Error 14.70
|
|
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
|
-49.0 percent change
Standard Error 40.94
|
-41.3 percent change
Standard Error 9.88
|
-65.1 percent change
Standard Error 11.42
|
-73.8 percent change
Standard Error 0.00
|
—
|
-88.4 percent change
Standard Error 13.41
|
-19.2 percent change
Standard Error 29.47
|
-58.7 percent change
Standard Error 12.22
|
-34.8 percent change
Standard Error 17.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-3.4 score on a scale
Standard Error 0.86
|
-8.0 score on a scale
Standard Error 1.96
|
-4.7 score on a scale
Standard Error 2.60
|
—
|
-4.5 score on a scale
Standard Error 2.99
|
0.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-10.0 score on a scale
Standard Error 1.83
|
-0.6 score on a scale
Standard Error 3.12
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-4.3 score on a scale
Standard Error 1.53
|
-8.3 score on a scale
Standard Error 2.01
|
-7.0 score on a scale
Standard Error 2.00
|
—
|
-3.0 score on a scale
Standard Error 4.55
|
-12.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-10.7 score on a scale
Standard Error 1.69
|
-1.5 score on a scale
Standard Error 3.76
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-4.8 score on a scale
Standard Error 1.83
|
-7.9 score on a scale
Standard Error 2.25
|
-10.0 score on a scale
Standard Error 1.00
|
—
|
-6.3 score on a scale
Standard Error 2.29
|
-5.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-10.0 score on a scale
Standard Error 1.82
|
-9.5 score on a scale
Standard Error 2.46
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-4.4 score on a scale
Standard Error 2.02
|
-8.7 score on a scale
Standard Error 2.28
|
-17.5 score on a scale
Standard Error 5.50
|
—
|
-6.5 score on a scale
Standard Error 2.18
|
-8.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-9.9 score on a scale
Standard Error 2.01
|
-9.2 score on a scale
Standard Error 2.04
|
|
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
|
0.0 score on a scale
Standard Error 0.00
|
-3.6 score on a scale
Standard Error 1.37
|
-8.3 score on a scale
Standard Error 2.01
|
-4.7 score on a scale
Standard Error 2.60
|
—
|
-3.0 score on a scale
Standard Error 4.55
|
-12.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-11.2 score on a scale
Standard Error 1.75
|
-1.4 score on a scale
Standard Error 3.33
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 18Population: 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.
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.
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in DLQI Total Score Over Time
Change at Week 4
|
-51.0 percent change
Standard Error 17.71
|
-3.7 percent change
Standard Error 25.35
|
-32.8 percent change
Standard Error 8.77
|
-52.4 percent change
Standard Error 10.95
|
-24.2 percent change
Standard Error 17.01
|
—
|
-53.5 percent change
Standard Error 33.55
|
6.1 percent change
Standard Error 94.72
|
-68.2 percent change
Standard Error 11.77
|
4.1 percent change
Standard Error 16.65
|
|
Percent Change From Baseline in DLQI Total Score Over Time
Change at Week 8
|
-54.5 percent change
Standard Error 12.95
|
-2.4 percent change
Standard Error 18.53
|
-41.1 percent change
Standard Error 13.32
|
-56.0 percent change
Standard Error 16.63
|
-24.2 percent change
Standard Error 17.01
|
—
|
-32.5 percent change
Standard Error 64.55
|
-85.7 percent change
Standard Error 182.21
|
-72.2 percent change
Standard Error 10.71
|
-2.3 percent change
Standard Error 15.15
|
|
Percent Change From Baseline in DLQI Total Score Over Time
Change at Week 12
|
-54.5 percent change
Standard Error 12.95
|
-2.4 percent change
Standard Error 18.53
|
-48.1 percent change
Standard Error 14.36
|
-55.7 percent change
Standard Error 16.59
|
-36.4 percent change
Standard Error 0.00
|
—
|
-32.5 percent change
Standard Error 64.55
|
-85.7 percent change
Standard Error 182.21
|
-72.9 percent change
Standard Error 11.58
|
-5.4 percent change
Standard Error 17.75
|
|
Percent Change From Baseline in DLQI Total Score Over Time
Change at Week 18
|
-52.5 percent change
Standard Error 18.16
|
-3.4 percent change
Standard Error 25.99
|
-44.0 percent change
Standard Error 12.37
|
-61.3 percent change
Standard Error 14.29
|
-89.7 percent change
Standard Error 0.00
|
—
|
-75.0 percent change
Standard Error 19.53
|
-52.4 percent change
Standard Error 55.14
|
-68.7 percent change
Standard Error 9.18
|
-62.6 percent change
Standard Error 14.08
|
|
Percent Change From Baseline in DLQI Total Score Over Time
Change at Week 16
|
-60.5 percent change
Standard Error 15.08
|
-2.5 percent change
Standard Error 21.57
|
-51.0 percent change
Standard Error 11.94
|
-54.0 percent change
Standard Error 13.79
|
-61.4 percent change
Standard Error 0.00
|
—
|
-71.9 percent change
Standard Error 23.07
|
-41.5 percent change
Standard Error 65.13
|
-69.6 percent change
Standard Error 8.18
|
-60.7 percent change
Standard Error 12.54
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 18Population: 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.
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).
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 4
|
-17.0 score on a scale
Standard Error 13.07
|
0.0 score on a scale
Standard Error 0.00
|
-10.9 score on a scale
Standard Error 3.63
|
-18.9 score on a scale
Standard Error 6.25
|
-27.3 score on a scale
Standard Error 15.32
|
—
|
-31.5 score on a scale
Standard Error 13.91
|
0.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-29.0 score on a scale
Standard Error 5.61
|
-16.9 score on a scale
Standard Error 7.04
|
|
Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 8
|
-23.3 score on a scale
Standard Error 9.08
|
-0.5 score on a scale
Standard Error 0.50
|
-17.8 score on a scale
Standard Error 4.61
|
-20.8 score on a scale
Standard Error 8.66
|
-27.3 score on a scale
Standard Error 15.32
|
—
|
-38.8 score on a scale
Standard Error 15.84
|
-10.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-35.8 score on a scale
Standard Error 5.88
|
-23.1 score on a scale
Standard Error 7.31
|
|
Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 12
|
-22.8 score on a scale
Standard Error 11.74
|
0.0 score on a scale
Standard Error 0.00
|
-22.0 score on a scale
Standard Error 5.96
|
-19.2 score on a scale
Standard Error 5.78
|
-47.0 score on a scale
Standard Error 6.00
|
—
|
-41.5 score on a scale
Standard Error 11.99
|
-18.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-35.5 score on a scale
Standard Error 6.54
|
-27.3 score on a scale
Standard Error 4.62
|
|
Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 16
|
-33.3 score on a scale
Standard Error 11.46
|
0.0 score on a scale
Standard Error 0.00
|
-19.9 score on a scale
Standard Error 5.18
|
-18.1 score on a scale
Standard Error 6.93
|
-50.0 score on a scale
Standard Error 3.00
|
—
|
-41.5 score on a scale
Standard Error 11.89
|
-18.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-38.1 score on a scale
Standard Error 5.66
|
-29.2 score on a scale
Standard Error 8.15
|
|
Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 18
|
-29.3 score on a scale
Standard Error 9.68
|
0.0 score on a scale
Standard Error 0.00
|
-25.1 score on a scale
Standard Error 7.18
|
-21.4 score on a scale
Standard Error 6.82
|
-64.5 score on a scale
Standard Error 14.50
|
—
|
-46.8 score on a scale
Standard Error 8.62
|
-15.0 score on a scale
Standard Error NA
1 participant in this cohort.
|
-32.9 score on a scale
Standard Error 6.40
|
-31.8 score on a scale
Standard Error 8.46
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 18Population: 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.
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).
Outcome measures
| Measure |
KPL-716: CIU Cohort
n=4 Participants
Participants with CIU received KPL-716 weekly for 8 weeks
|
Placebo: CIU Cohort
n=2 Participants
Participants with CIU received placebo weekly for 8 weeks
|
KPL-716: CIP Cohort
n=14 Participants
Participants with CIP received KPL-716 weekly for 8 weeks
|
Placebo: CIP Cohort
n=9 Participants
Participants with CIP received placebo weekly for 8 weeks
|
KPL-716: LP Cohort
n=3 Participants
Participants with LP received KPL-716 weekly for 8 weeks
|
Placebo: LP Cohort
Participants with LP received placebo weekly for 8 weeks
|
KPL-716: LSC Cohort
n=4 Participants
Participants with LSC received KPL-716 weekly for 8 weeks
|
Placebo: LSC Cohort
n=1 Participants
Participants with LSC received placebo weekly for 8 weeks
|
KPL-716: PPs Cohort
n=14 Participants
Participants with PPs received KPL-716 weekly for 8 weeks
|
Placebo: PPs Cohort
n=7 Participants
Participants with PPs received placebo weekly for 8 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 4
|
-21.4 percent change
Standard Error 16.56
|
-0.2 percent change
Standard Error 23.57
|
-13.0 percent change
Standard Error 5.15
|
-24.3 percent change
Standard Error 6.43
|
-29.1 percent change
Standard Error 7.02
|
—
|
-47.8 percent change
Standard Error 17.37
|
39.7 percent change
Standard Error 46.22
|
-34.8 percent change
Standard Error 5.84
|
-14.6 percent change
Standard Error 8.32
|
|
Percent Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 8
|
-29.2 percent change
Standard Error 11.47
|
-0.6 percent change
Standard Error 16.32
|
-23.7 percent change
Standard Error 7.21
|
-26.0 percent change
Standard Error 9.01
|
-29.1 percent change
Standard Error 7.02
|
—
|
-56.3 percent change
Standard Error 23.23
|
27.3 percent change
Standard Error 61.79
|
-42.7 percent change
Standard Error 6.29
|
-21.9 percent change
Standard Error 8.97
|
|
Percent Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 12
|
-28.3 percent change
Standard Error 14.70
|
0.2 percent change
Standard Error 20.91
|
-29.4 percent change
Standard Error 6.30
|
-25.0 percent change
Standard Error 7.29
|
-50.9 percent change
Standard Error 0.00
|
—
|
-58.2 percent change
Standard Error 15.85
|
12.0 percent change
Standard Error 42.18
|
-42.7 percent change
Standard Error 6.58
|
-26.0 percent change
Standard Error 10.25
|
|
Percent Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 16
|
-41.7 percent change
Standard Error 14.66
|
-0.2 percent change
Standard Error 20.86
|
-26.5 percent change
Standard Error 6.61
|
-23.2 percent change
Standard Error 7.65
|
-54.6 percent change
Standard Error 0.00
|
—
|
-59.8 percent change
Standard Error 12.34
|
19.8 percent change
Standard Error 32.82
|
-45.8 percent change
Standard Error 6.06
|
-29.4 percent change
Standard Error 9.44
|
|
Percent Change From Baseline in ItchyQoL Total Score Over Time
Change at Week 18
|
-36.6 percent change
Standard Error 12.16
|
0.0 percent change
Standard Error 17.30
|
-32.5 percent change
Standard Error 7.93
|
-27.6 percent change
Standard Error 9.17
|
-69.2 percent change
Standard Error 0.00
|
—
|
-63.8 percent change
Standard Error 7.49
|
10.2 percent change
Standard Error 19.94
|
-39.6 percent change
Standard Error 7.06
|
-31.7 percent change
Standard Error 11.00
|
Adverse Events
KPL-716
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KPL-716
n=39 participants at risk
KPL-716 weekly for 8 weeks
|
Placebo
n=19 participants at risk
Placebo weekly for 8 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
Other adverse events
| Measure |
KPL-716
n=39 participants at risk
KPL-716 weekly for 8 weeks
|
Placebo
n=19 participants at risk
Placebo weekly for 8 weeks
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
2/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Influenza
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Sinusitis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Conjunctivitis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Lymphangitis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
2/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
10.5%
2/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Investigations
Cardiac murmur
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Investigations
Platelet count decreased
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Investigations
Electrocardioagram T wave abnormal
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
General disorders
Fatigue
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
10.5%
2/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
General disorders
Chest pain
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Renal and urinary disorders
Renal colic
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
5.3%
1/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Eye disorders
Chalazion
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.6%
1/39 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
0.00%
0/19 • From first dose of study treatment through the end-of-study visit (Week 18).
The adverse event 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the first right to publish study results. PI may publish study results after Sponsor publishes the study results or 18 months after study completion at all participating sites, whichever comes first, provided that Sponsor may embargo such publication for up to 60 days for purposes of identifying confidential information that must be removed and up to an additional 60 days to prepare a patent application if there is patentable subject matter in the PI's proposed publication.
- Publication restrictions are in place
Restriction type: OTHER