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Trial record 2 of 2 for:    Vixarelimab

A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858634
Recruitment Status : Completed
First Posted : March 1, 2019
Results First Posted : December 28, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Idiopathic Urticaria
Chronic Idiopathic Pruritus
Lichen Planus
Lichen Simplex Chronicus
Plaque Psoriasis
Interventions Drug: KPL-716
Drug: Placebo
Enrollment 58
Recruitment Details  
Pre-assignment Details This study assigned participants to active treatment or placebo in 5 individual disease-specific cohorts: chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs). The participant flow data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.
Arm/Group Title KPL-716 Placebo
Hide Arm/Group Description KPL-716 weekly for 8 weeks Placebo weekly for 8 weeks
Period Title: Overall Study
Started 39 19
Participants With Chronic Idiopathic Urticaria (CIU) 4 2
Participants With Chronic Idiopathic Pruritus (CIP) 14 9
Participants With Lichen Planus (LP) 3 0
Participants With Lichen Simplex Chronicus (LSC) 4 1
Participants With Plaque Psoriasis (PPs) 14 7
Completed 36 17
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             0
Lost to Follow-up             0             1
Other, Not Specified             1             1
Arm/Group Title KPL-716 Placebo Total
Hide Arm/Group Description KPL-716 weekly for 8 weeks Placebo weekly for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 39 19 58
Hide Baseline Analysis Population Description
The baseline characteristics 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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 19 participants 58 participants
53.1  (11.51) 53.3  (13.94) 53.2  (12.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Female
27
  69.2%
14
  73.7%
41
  70.7%
Male
12
  30.8%
5
  26.3%
17
  29.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
White
34
  87.2%
14
  73.7%
48
  82.8%
Black or African American
4
  10.3%
4
  21.1%
8
  13.8%
Asian
1
   2.6%
1
   5.3%
2
   3.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Hispanic or Latino
20
  51.3%
5
  26.3%
25
  43.1%
Not Hispanic or Latino
19
  48.7%
14
  73.7%
33
  56.9%
Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 39 participants 19 participants 58 participants
8.1  (0.93) 8.3  (1.14) 8.2  (1.00)
[1]
Measure Description: 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 of Day -6 to Day 1 were averaged.
1.Primary Outcome
Title Change From Baseline in Weekly Average WI-NRS at Week 8
Hide Description WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.3  (1.84) -1.1  (2.66) -4.3  (0.77) -3.7  (0.96) -3.1  (0.82) -6.9  (0.81) 0.7  (1.84) -5.6  (0.69) -2.5  (0.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3980
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value -3.3
Confidence Interval (2-Sided) 80%
-8.68 to 2.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6653
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 80%
-2.17 to 1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.6
Confidence Interval (2-Sided) 80%
-11.63 to -3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.1
Confidence Interval (2-Sided) 80%
-4.70 to -1.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.20
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline in Weekly Average WI-NRS at Week 8
Hide Description WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-50.7  (21.56) -19.0  (31.07) -52.4  (9.32) -48.8  (11.63) -39.4  (10.21) -85.0  (11.76) 7.0  (26.80) -66.5  (7.78) -29.0  (11.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4734
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -31.7
Confidence Interval (2-Sided) 80%
-95.11 to 31.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8130
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.6
Confidence Interval (2-Sided) 80%
-23.33 to 16.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0979
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -92.0
Confidence Interval (2-Sided) 80%
-150.60 to -33.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 31.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.5
Confidence Interval (2-Sided) 80%
-55.48 to -19.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.48
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Weekly Average WI-NRS Over Time
Hide Description WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 1-18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Mean (Standard Error)
Unit of Measure: score on a scale
Change at Week 1 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-1.9  (0.59) -0.9  (0.86) -1.6  (0.55) -1.4  (0.45) -0.2  (0.13) -3.0  (1.23) -0.9 [1]   (NA) -0.7  (0.17) -0.2  (0.16)
Change at Week 2 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.0  (0.79) -1.3  (1.29) -3.0  (0.60) -2.9  (0.63) -0.5  (0.58) -4.0  (1.64) -1.0 [1]   (NA) -1.5  (0.27) -0.7  (0.26)
Change at Week 3 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.8  (1.25) -1.6  (1.64) -3.5  (0.61) -2.4  (0.72) -1.2  (0.99) -4.6  (1.73) -1.4 [1]   (NA) -2.6  (0.39) -0.9  (0.33)
Change at Week 4 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.9  (1.59) -1.5  (1.50) -3.5  (0.64) -3.0  (0.85) -2.3  (1.78) -5.0  (1.48) -2.4 [1]   (NA) -3.4  (0.48) -1.2  (0.63)
Change at Week 5 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.4  (1.83) -1.6  (1.64) -4.1  (0.73) -3.1  (0.88) -2.5  (1.91) -5.4  (1.58) -2.0 [1]   (NA) -4.4  (0.65) -1.5  (0.88)
Change at Week 6 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.6  (1.72) -1.8  (1.79) -4.2  (0.74) -3.7  (0.92) -2.7  (1.90) -5.8  (1.58) -2.6 [1]   (NA) -4.7  (0.65) -1.6  (0.81)
Change at Week 7 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.4  (1.75) -2.6  (2.64) -4.4  (0.77) -3.7  (0.81) -3.1  (1.94) -6.3  (1.48) -2.3 [1]   (NA) -5.1  (0.69) -1.9  (0.91)
Change at Week 8 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.1  (1.84) -1.6  (1.57) -4.3  (0.75) -3.7  (0.94) -3.1  (1.94) -6.0  (1.61) -2.7 [1]   (NA) -5.6  (0.66) -2.5  (1.07)
Change at Week 9 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.1  (1.73) -1.6  (1.57) -4.6  (0.88) -3.8  (0.76) -5.0  (1.00) -6.0  (1.76) -3.3 [1]   (NA) -5.7  (0.70) -2.5  (1.21)
Change at Week 10 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.1  (1.69) -2.2  (2.21) -4.3  (0.87) -4.7  (0.64) -5.0  (1.00) -6.3  (1.46) -3.0 [1]   (NA) -5.6  (0.75) -2.2  (1.23)
Change at Week 11 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.1  (1.74) -2.2  (2.21) -4.4  (0.90) -4.9  (0.75) -5.0  (1.00) -6.3  (1.42) -2.9 [1]   (NA) -5.4  (0.78) -2.2  (1.22)
Change at Week 12 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.5  (1.72) -2.2  (2.21) -4.4  (0.86) -4.3  (0.76) -5.3  (0.71) -6.5  (1.27) -2.7 [1]   (NA) -5.3  (0.80) -2.2  (1.21)
Change at Week 13 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.9  (1.85) -2.2  (2.21) -4.4  (0.83) -4.2  (0.86) -5.5  (0.50) -6.6  (1.32) -2.0 [1]   (NA) -5.5  (0.83) -2.3  (1.22)
Change at Week 14 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.8  (1.75) -2.2  (2.21) -4.5  (0.80) -4.1  (0.92) -5.5  (0.50) -6.4  (1.42) -1.9 [1]   (NA) -5.6  (0.81) -2.3  (1.21)
Change at Week 15 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.4  (1.68) -2.2  (2.21) -4.2  (0.85) -3.8  (0.91) -5.5  (0.50) -6.8  (1.23) -2.0 [1]   (NA) -5.4  (0.86) -2.6  (1.35)
Change at Week 16 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.1  (1.74) -2.2  (2.21) -4.3  (0.87) -3.5  (0.96) -5.5  (0.50) -6.6  (1.25) -1.6 [1]   (NA) -5.3  (0.86) -2.6  (1.33)
Change at Week 17 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.5  (1.81) -2.2  (2.21) -4.5  (0.89) -3.4  (0.97) -5.5  (0.50) -6.8  (1.11) -1.4 [1]   (NA) -5.0  (0.99) -2.7  (1.38)
Change at Week 18 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.4  (1.67) -2.2  (2.21) -4.3  (0.97) -3.4  (1.06) -5.6  (0.57) -6.9  (1.01) -1.4 [1]   (NA) -5.0  (1.01) -2.7  (1.39)
[1]
1 participant in this cohort.
4.Secondary Outcome
Title Percent Change From Baseline in Weekly Average WI-NRS Over Time
Hide Description WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 1-18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Change at Week 1 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-23.5  (8.22) -16.2  (11.84) -19.5  (6.57) -18.3  (8.20) -2.4  (2.19) -44.2  (12.54) 16.9  (28.60) -8.8  (1.84) -3.4  (2.61)
Change at Week 2 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-37.2  (12.11) -20.6  (17.45) -36.7  (7.42) -36.5  (9.25) -6.1  (4.37) -59.8  (10.80) 29.3  (24.62) -17.8  (3.16) -8.4  (4.46)
Change at Week 3 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-46.9  (18.33) -25.0  (26.41) -43.4  (7.37) -31.5  (9.19) -15.0  (8.02) -67.9  (12.89) 25.9  (29.39) -31.2  (4.14) -11.2  (5.86)
Change at Week 4 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-48.9  (19.96) -20.0  (28.76) -43.9  (7.92) -38.4  (9.87) -29.3  (18.23) -71.7  (9.93) 8.0  (22.65) -41.7  (5.63) -14.5  (7.96)
Change at Week 5 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-54.7  (23.35) -22.0  (33.65) -51.6  (8.70) -40.6  (10.84) -31.1  (20.41) -76.9  (13.08) 13.8  (29.81) -53.0  (7.11) -17.7  (10.05)
Change at Week 6 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-57.3  (21.58) -23.8  (31.10) -52.3  (9.11) -47.9  (11.36) -33.5  (17.50) -81.5  (13.07) 7.0  (29.80) -56.5  (6.88) -18.7  (9.72)
Change at Week 7 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-53.6  (24.07) -36.4  (34.67) -54.3  (8.98) -48.1  (11.19) -39.4  (10.21) -87.4  (11.02) 7.8  (25.13) -60.6  (7.48) -22.5  (10.57)
Change at Week 8 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-50.7  (21.56) -19.0  (31.07) -52.4  (9.32) -48.8  (11.63) -39.4  (10.21) -85.0  (11.76) 7.0  (26.80) -66.5  (7.78) -29.0  (11.00)
Change at Week 9 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-51.1  (19.68) -19.0  (28.35) -55.7  (9.95) -48.6  (11.50) -62.5  (12.50) -85.2  (14.00) 4.0  (31.91) -68.1  (8.42) -28.5  (11.91)
Change at Week 10 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-50.0  (20.26) -27.9  (29.19) -52.6  (9.40) -58.7  (10.86) -62.5  (12.50) -86.8  (11.34) -1.2  (25.85) -67.0  (8.73) -24.5  (12.35)
Change at Week 11 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-50.4  (20.87) -27.3  (30.07) -52.8  (9.91) -61.4  (11.45) -62.5  (12.50) -86.6  (10.72) -0.4  (24.44) -64.1  (8.66) -24.8  (12.25)
Change at Week 12 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-55.4  (21.36) -28.2  (30.77) -53.9  (9.88) -53.2  (11.42) -66.1  (8.93) -89.0  (8.84) -2.8  (20.15) -62.2  (8.85) -24.8  (12.52)
Change at Week 13 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-47.2  (22.72) -27.6  (32.73) -53.8  (10.04) -52.2  (11.59) -68.8  (6.25) -90.1  (10.04) 6.1  (22.89) -64.9  (9.22) -25.2  (13.03)
Change at Week 14 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-46.8  (20.94) -27.7  (30.17) -55.3  (10.15) -51.4  (11.72) -68.8  (6.25) -88.8  (10.85) 10.7  (24.74) -65.9  (9.17) -26.1  (12.97)
Change at Week 15 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-53.6  (20.68) -28.2  (29.79) -50.8  (10.54) -49.0  (12.18) -68.8  (6.25) -91.8  (9.58) 3.0  (21.85) -63.7  (9.87) -29.5  (13.96)
Change at Week 16 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-50.0  (21.31) -28.0  (30.70) -51.7  (10.86) -44.7  (12.54) -68.8  (6.25) -90.6  (9.28) 9.1  (21.17) -62.7  (9.81) -29.3  (13.88)
Change at Week 17 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-55.0  (23.07) -28.7  (33.24) -54.2  (11.00) -43.7  (12.70) -68.8  (6.25) -92.2  (8.10) 6.8  (18.46) -58.0  (11.35) -30.8  (16.05)
Change at Week 18 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-54.5  (20.93) -28.9  (30.15) -51.5  (12.05) -43.7  (13.92) -69.6  (7.14) -92.1  (6.42) 4.1  (14.63) -58.1  (11.43) -31.1  (16.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6533
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.3
Confidence Interval (2-Sided) 80%
-31.52 to 16.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9077
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 80%
-15.16 to 12.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2065
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -61.2
Confidence Interval (2-Sided) 80%
-123.73 to 1.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 33.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1133
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.3
Confidence Interval (2-Sided) 80%
-9.56 to -1.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4997
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -16.7
Confidence Interval (2-Sided) 80%
-52.29 to 18.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 21.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9919
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 80%
-15.83 to 15.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0891
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -89.2
Confidence Interval (2-Sided) 80%
-143.03 to -35.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 28.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1029
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.4
Confidence Interval (2-Sided) 80%
-16.67 to -2.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5538
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -21.9
Confidence Interval (2-Sided) 80%
-75.82 to 32.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 32.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3252
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -11.9
Confidence Interval (2-Sided) 80%
-27.51 to 3.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1106
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -93.8
Confidence Interval (2-Sided) 80%
-158.11 to -29.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 34.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.9
Confidence Interval (2-Sided) 80%
-29.48 to -10.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4791
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -28.9
Confidence Interval (2-Sided) 80%
-87.63 to 29.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 35.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6684
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.5
Confidence Interval (2-Sided) 80%
-22.28 to 11.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0937
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -79.7
Confidence Interval (2-Sided) 80%
-129.22 to -30.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 26.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0120
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.2
Confidence Interval (2-Sided) 80%
-40.21 to -14.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4927
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -32.7
Confidence Interval (2-Sided) 80%
-101.39 to 36.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 41.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4409
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.9
Confidence Interval (2-Sided) 80%
-29.35 to 7.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1197
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -90.7
Confidence Interval (2-Sided) 80%
-155.96 to -25.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 34.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -35.3
Confidence Interval (2-Sided) 80%
-51.68 to -18.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4515
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -33.5
Confidence Interval (2-Sided) 80%
-96.97 to 30.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7623
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.5
Confidence Interval (2-Sided) 80%
-23.76 to 14.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1247
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -88.5
Confidence Interval (2-Sided) 80%
-153.65 to -23.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 34.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.7
Confidence Interval (2-Sided) 80%
-53.59 to -21.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7177
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.2
Confidence Interval (2-Sided) 80%
-87.97 to 53.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 43.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6682
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.2
Confidence Interval (2-Sided) 80%
-25.26 to 12.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0823
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -95.2
Confidence Interval (2-Sided) 80%
-150.21 to -40.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 29.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0087
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -38.1
Confidence Interval (2-Sided) 80%
-55.38 to -20.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4734
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -31.7
Confidence Interval (2-Sided) 80%
-95.11 to 31.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8130
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.6
Confidence Interval (2-Sided) 80%
-23.33 to 16.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0979
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -92.0
Confidence Interval (2-Sided) 80%
-150.60 to -33.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 31.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.5
Confidence Interval (2-Sided) 80%
-55.48 to -19.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4310
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -32.1
Confidence Interval (2-Sided) 80%
-89.98 to 25.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 35.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6452
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.1
Confidence Interval (2-Sided) 80%
-27.38 to 13.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1375
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -89.2
Confidence Interval (2-Sided) 80%
-159.04 to -19.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0143
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -39.6
Confidence Interval (2-Sided) 80%
-58.97 to -20.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5867
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -22.1
Confidence Interval (2-Sided) 80%
-81.70 to 37.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 36.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6745
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.1
Confidence Interval (2-Sided) 80%
-12.99 to 25.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1039
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -85.6
Confidence Interval (2-Sided) 80%
-142.18 to -29.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 29.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -42.5
Confidence Interval (2-Sided) 80%
-62.60 to -22.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 11
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5807
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -23.1
Confidence Interval (2-Sided) 80%
-84.55 to 38.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 11
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5765
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 8.6
Confidence Interval (2-Sided) 80%
-11.55 to 28.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 11
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0933
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -86.2
Confidence Interval (2-Sided) 80%
-139.70 to -32.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 28.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 11
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0173
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -39.3
Confidence Interval (2-Sided) 80%
-59.29 to -19.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5293
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.2
Confidence Interval (2-Sided) 80%
-90.04 to 35.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9676
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.6
Confidence Interval (2-Sided) 80%
-20.73 to 19.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0663
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -86.2
Confidence Interval (2-Sided) 80%
-130.27 to -42.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 23.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0252
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.4
Confidence Interval (2-Sided) 80%
-57.81 to -17.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 13
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6637
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.6
Confidence Interval (2-Sided) 80%
-86.45 to 47.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 40.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 13
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9173
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.6
Confidence Interval (2-Sided) 80%
-22.04 to 18.81
Parameter Dispersion
Type: Standard Deviation
Value: 15.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 13
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0685
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -96.2
Confidence Interval (2-Sided) 80%
-146.23 to -46.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 26.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 13
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0230
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -39.7
Confidence Interval (2-Sided) 80%
-60.91 to -18.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6471
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.1
Confidence Interval (2-Sided) 80%
-80.69 to 42.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8044
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.9
Confidence Interval (2-Sided) 80%
-24.56 to 16.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0741
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -99.5
Confidence Interval (2-Sided) 80%
-153.63 to -45.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 28.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0219
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -39.9
Confidence Interval (2-Sided) 80%
-61.00 to -18.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5436
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -25.4
Confidence Interval (2-Sided) 80%
-86.21 to 35.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9149
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.7
Confidence Interval (2-Sided) 80%
-23.20 to 19.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0646
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -94.8
Confidence Interval (2-Sided) 80%
-142.63 to -47.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 25.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0611
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -34.2
Confidence Interval (2-Sided) 80%
-56.89 to -11.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 17.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6060
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -22.0
Confidence Interval (2-Sided) 80%
-84.68 to 40.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6823
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.9
Confidence Interval (2-Sided) 80%
-29.00 to 15.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0556
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -99.7
Confidence Interval (2-Sided) 80%
-146.02 to -53.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 24.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0652
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -33.4
Confidence Interval (2-Sided) 80%
-55.98 to -10.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 17
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5714
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -26.3
Confidence Interval (2-Sided) 80%
-94.14 to 41.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 41.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 17
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5386
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.5
Confidence Interval (2-Sided) 80%
-32.93 to 11.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 17
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0438
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -99.0
Confidence Interval (2-Sided) 80%
-139.35 to -58.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 21.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 17
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1829
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.2
Confidence Interval (2-Sided) 80%
-53.38 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 18
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5443
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -25.6
Confidence Interval (2-Sided) 80%
-87.20 to 35.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 18
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6748
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.9
Confidence Interval (2-Sided) 80%
-32.39 to 16.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 18
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0297
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -96.2
Confidence Interval (2-Sided) 80%
-128.19 to -64.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 18
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1899
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.0
Confidence Interval (2-Sided) 80%
-53.33 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.80
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
Hide Description Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Time Frame Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 1 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-1.7  (0.98) 0.0  (0.00) -1.3  (0.79) -2.0  (0.78) -0.4  (0.26) -4.0  (1.61) -0.7 [1]   (NA) -1.3  (0.29) -0.3  (0.28)
Change at Week 2 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-2.8  (1.43) 0.0  (0.00) -3.0  (0.96) -2.6  (0.62) -0.4  (0.19) -4.4  (1.80) -1.0 [1]   (NA) -2.2  (0.55) -0.7  (0.31)
Change at Week 3 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-3.3  (1.52) -0.1  (0.10) -3.2  (1.09) -3.4  (0.97) -2.0  (1.36) -5.2  (1.85) -2.2 [1]   (NA) -3.4  (0.55) -0.9  (0.81)
Change at Week 4 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.3  (1.67) 0.0  (0.00) -3.7  (0.94) -3.9  (0.95) -2.8  (1.88) -5.3  (1.66) -2.2 [1]   (NA) -4.3  (0.54) -1.4  (0.94)
Change at Week 5 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-5.2  (1.82) 0.0  (0.00) -4.5  (1.01) -4.7  (0.88) -3.0  (1.86) -5.7  (1.67) -3.7 [1]   (NA) -4.3  (0.51) -1.6  (0.99)
Change at Week 6 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.4  (1.88) 0.0  (0.00) -4.5  (1.00) -4.2  (1.07) -3.1  (1.85) -5.9  (1.57) -2.0 [1]   (NA) -5.2  (0.54) -1.9  (1.05)
Change at Week 7 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-5.1  (1.78) -0.1  (0.10) -4.7  (1.05) -4.7  (0.88) -3.3  (1.85) -6.1  (1.45) -1.4 [1]   (NA) -5.3  (0.57) -2.1  (1.27)
Change at Week 8 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-4.2  (2.00) 0.0  (0.00) -4.4  (1.03) -4.3  (0.95) -3.3  (1.85) -6.0  (1.42) -1.8 [1]   (NA) -5.8  (0.61) -2.2  (1.29)
Change at Week 10 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-4.8  (1.86) 0.0  (0.00) -4.2  (1.07) -5.8  (0.58) -5.6  (0.85) -6.2  (1.50) -3.5 [1]   (NA) -5.9  (0.66) -3.1  (1.36)
Change at Week 12 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-4.1  (2.11) 0.0  (0.00) -4.7  (1.10) -4.8  (1.18) -5.1  (1.30) -6.3  (1.37) -3.5 [1]   (NA) -5.6  (0.71) -3.8  (1.26)
Change at Week 14 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-3.5  (2.19) 0.0  (0.00) -5.0  (1.00) -4.2  (1.06) -5.3  (1.10) -6.4  (1.31) -1.4 [1]   (NA) -5.8  (0.75) -3.6  (1.37)
Change at Week 16 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-4.5  (1.91) -0.1  (0.05) -4.2  (1.07) -4.0  (1.13) -5.6  (0.85) -6.6  (1.12) -0.8 [1]   (NA) -5.6  (0.79) -3.5  (1.41)
Change at Week 18 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-3.9  (2.07) 0.0  (0.00) -4.2  (1.22) -3.6  (1.20) -5.6  (2.40) -7.0  (0.74) -0.9 [1]   (NA) -5.4  (0.90) -3.9  (1.31)
[1]
1 participant in this cohort
6.Secondary Outcome
Title Percent Change From Baseline in Pruritus VAS Over Time
Hide Description Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Time Frame Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.
Arm/Group Title KPL-716: CIU Cohort Placebo: CIU Cohort KPL-716: CIP Cohort Placebo: CIP Cohort KPL-716: LP Cohort Placebo: LP Cohort KPL-716: LSC Cohort Placebo: LSC Cohort KPL-716: PPs Cohort Placebo: PPs Cohort
Hide Arm/Group Description:
Participants with CIU received KPL-716 weekly for 8 weeks
Participants with CIU received placebo weekly for 8 weeks
Participants with CIP received KPL-716 weekly for 8 weeks
Participants with CIP received placebo weekly for 8 weeks
Participants with LP received KPL-716 weekly for 8 weeks
Participants with LP received placebo weekly for 8 weeks
Participants with LSC received KPL-716 weekly for 8 weeks
Participants with LSC received placebo weekly for 8 weeks
Participants with PPs received KPL-716 weekly for 8 weeks
Participants with PPs received placebo weekly for 8 weeks
Overall Number of Participants Analyzed 4 2 14 9 3 0 4 1 14 7
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Change at Week 1 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-23.6  (13.76) -8.3  (19.72) -15.3  (9.17) -24.8  (11.44) -5.3  (1.80) -76.1  (27.14) 90.9  (85.95) -15.4  (3.19) -4.6  (4.52)
Change at Week 2 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-37.4  (19.67) -4.3  (28.19) -34.2  (9.66) -32.8  (12.04) -5.1  (3.22) -79.6  (34.28) 81.3  (108.56) -24.2  (5.50) -10.1  (7.78)
Change at Week 3 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-43.3  (19.79) -2.6  (28.36) -37.4  (12.12) -44.5  (15.12) -26.2  (8.32) -97.1  (28.92) 96.7  (91.57) -40.6  (6.26) -10.3  (8.87)
Change at Week 4 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-54.9  (19.93) -0.9  (28.57) -44.4  (10.57) -50.7  (13.18) -37.3  (12.60) -93.6  (28.13) 74.8  (89.08) -52.7  (6.55) -16.0  (9.27)
Change at Week 5 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-66.3  (21.37) -0.2  (30.63) -54.1  (10.84) -60.4  (13.52) -40.0  (15.97) -99.4  (26.68) 64.0  (84.47) -52.5  (6.54) -19.1  (9.26)
Change at Week 6 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-57.2  (22.58) -1.2  (32.37) -53.0  (11.31) -52.4  (14.11) -41.6  (17.99) -101.0  (24.68) 76.3  (78.14) -63.5  (6.90) -21.5  (9.77)
Change at Week 7 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-65.7  (18.99) 0.1  (27.22) -55.7  (10.97) -60.8  (13.68) -44.3  (21.36) -101.8  (22.55) 73.6  (71.40) -64.6  (7.89) -25.4  (11.18)
Change at Week 8 Number Analyzed 4 participants 2 participants 14 participants 9 participants 3 participants 0 participants 4 participants 1 participants 14 participants 7 participants
-54.1  (22.59) -0.4  (32.38) -52.1  (11.11) -55.0  (13.86) -44.3  (21.36) -99.2  (23.11) 63.8  (73.18) -70.9  (8.44) -25.2  (11.96)
Change at Week 10 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-61.6  (20.31) 0.7  (29.11) -50.7  (10.73) -72.2  (12.39) -76.9  (0.00) -103.9  (22.62) 57.5  (71.64) -70.6  (8.32) -36.2  (12.71)
Change at Week 12 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-51.9  (21.21) 3.3  (30.40) -56.3  (12.44) -58.7  (14.37) -69.7  (0.00) -102.9  (21.13) 46.3  (66.92) -67.6  (8.32) -45.5  (12.71)
Change at Week 14 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-44.2  (20.40) 4.4  (29.24) -60.8  (11.32) -51.2  (13.07) -72.9  (0.00) -103.3  (19.74) 64.5  (62.52) -69.6  (8.91) -42.5  (13.61)
Change at Week 16 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-56.8  (14.02) 5.1  (20.09) -49.5  (11.91) -48.9  (13.75) -76.9  (0.00) -102.0  (16.87) 57.2  (53.41) -68.1  (9.43) -41.6  (14.40)
Change at Week 18 Number Analyzed 4 participants 2 participants 12 participants 9 participants 2 participants 0 participants 4 participants 1 participants 14 participants 6 participants
-47.8  (14.97) 6.8  (21.45) -49.1  (13.66) -45.0  (15.77) -74.6  (0.00) -101.3  (9.93) 29.5  (31.43) -64.5  (10.23) -46.0  (15.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5763
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -15.3
Confidence Interval (2-Sided) 80%
-55.37 to 24.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 24.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5214
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 9.6
Confidence Interval (2-Sided) 80%
-9.86 to 29.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2536
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -167.0
Confidence Interval (2-Sided) 80%
-365.51 to 31.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 105.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0670
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.8
Confidence Interval (2-Sided) 80%
-18.20 to -3.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4133
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -33.1
Confidence Interval (2-Sided) 80%
-90.43 to 24.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 34.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9305
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.4
Confidence Interval (2-Sided) 80%
-21.83 to 19.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3499
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -160.9
Confidence Interval (2-Sided) 80%
-411.65 to 89.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 132.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1588
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -14.0
Confidence Interval (2-Sided) 80%
-26.74 to -1.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3319
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -40.6
Confidence Interval (2-Sided) 80%
-98.26 to 17.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 35.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection KPL-716: CIP Cohort, Placebo: CIP Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7179
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.1
Confidence Interval (2-Sided) 80%
-18.59 to 32.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection KPL-716: LSC Cohort, Placebo: LSC Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2261
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -193.8
Confidence Interval (2-Sided) 80%
-405.34 to 17.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 112.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection KPL-716: PPs Cohort, Placebo: PPs Cohort
Comments Change at Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -30.3
Confidence Interval (2-Sided) 80%
-44.75 to -15.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection KPL-716: CIU Cohort, Placebo: CIU Cohort
Comments Change at Week 4