Trial Outcomes & Findings for A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis (NCT NCT02969525)
NCT ID: NCT02969525
Last Updated: 2023-03-20
Results Overview
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
COMPLETED
PHASE2
206 participants
Week 12
2023-03-20
Participant Flow
The study started to enroll patients in October 2016 and concluded in July 2018.
The study included a 28-Day Screening Period, followed by a Double-blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post week 48. The Participant Flow refers to the Randomized Set and Dose-Blind Set.
Participant milestones
| Measure |
Placebo
Participants received Placebo during the 12 Weeks Double-Blind Period.
|
BKZ 16 mg
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 160 mg
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
BKZ 160 mg LD
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 320 mg
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
Placebo - BKZ 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
Placebo - BZK 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
BKZ 16 mg - BKZ 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 16 mg - BZK 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 160 mg LD - BZK 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 160 mg - BKZ Dose 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 320 mg - BKZ 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Period
STARTED
|
42
|
41
|
41
|
41
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Completed Double-Blind Period
|
42
|
41
|
40
|
39
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Completed Wk12 and Started Dose-Blind
|
40
|
41
|
40
|
37
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
COMPLETED
|
40
|
41
|
40
|
37
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
2
|
0
|
1
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose-Blind Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
20
|
20
|
22
|
19
|
37
|
40
|
41
|
|
Dose-Blind Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
20
|
18
|
22
|
18
|
34
|
38
|
39
|
|
Dose-Blind Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Placebo during the 12 Weeks Double-Blind Period.
|
BKZ 16 mg
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 160 mg
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
BKZ 160 mg LD
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 320 mg
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
Placebo - BKZ 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
Placebo - BZK 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
BKZ 16 mg - BKZ 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 16 mg - BZK 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 160 mg LD - BZK 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BZK 160 mg - BKZ Dose 160 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 320 mg - BKZ 320 mg
After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
LOW EGFR
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Study medication discontinued prior Wk12
|
2
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose-Blind Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Dose-Blind Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
0
|
0
|
|
Dose-Blind Period
Non-cooperating patient
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose-Blind Period
Withdrew before Safety Follow-up visit
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period.
|
BKZ 16 mg
n=41 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 160 mg
n=41 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
BKZ 160 mg LD
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
|
BKZ 320 mg
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
|
Total Title
n=206 Participants
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
185 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Age, Continuous
|
49.02 years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
49.98 years
STANDARD_DEVIATION 13.56 • n=7 Participants
|
48.00 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
49.05 years
STANDARD_DEVIATION 12.99 • n=4 Participants
|
50.39 years
STANDARD_DEVIATION 12.08 • n=21 Participants
|
49.29 years
STANDARD_DEVIATION 12.39 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
105 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
|
7.1 percentage of subjects
|
26.8 percentage of subjects
|
41.5 percentage of subjects
|
46.3 percentage of subjects
|
24.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
|
19.0 percentage of subjects
|
53.7 percentage of subjects
|
73.2 percentage of subjects
|
61.0 percentage of subjects
|
51.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
|
4.8 percentage of subjects
|
12.2 percentage of subjects
|
19.5 percentage of subjects
|
31.7 percentage of subjects
|
14.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo (FAS)
n=20 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=14 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=16 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=17 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=11 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
|
10.0 percentage of subjects
|
35.7 percentage of subjects
|
62.5 percentage of subjects
|
52.9 percentage of subjects
|
45.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo (FAS)
n=20 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=14 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=16 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=17 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=11 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
|
10.0 percentage of subjects
|
57.1 percentage of subjects
|
68.8 percentage of subjects
|
70.6 percentage of subjects
|
72.7 percentage of subjects
|
SECONDARY outcome
Timeframe: From Screening Period until the Safety Follow-Up Visit (up to Week 72)Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=126 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=80 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE) During the Study
|
57.1 percentage of participants
|
33.33 percentage of participants
|
74.6 percentage of participants
|
72.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Screening Period until the Safety Follow-Up Visit (up to Week 72)Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=126 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=80 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
|
2.4 percentage of participants
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Screening Period until the Safety Follow-Up Visit (up to Week 72)Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=126 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=80 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
|
4.8 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
2.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 12 post dose
|
-0.3 mmHg
Standard Deviation 9.6
|
-2.0 mmHg
Standard Deviation 10.0
|
0.3 mmHg
Standard Deviation 8.3
|
-1.8 mmHg
Standard Deviation 7.9
|
-2.6 mmHg
Standard Deviation 8.0
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 16 post dose
|
-3.0 mmHg
Standard Deviation 9.1
|
-1.9 mmHg
Standard Deviation 8.3
|
-1.7 mmHg
Standard Deviation 9.2
|
-1.1 mmHg
Standard Deviation 7.9
|
-2.4 mmHg
Standard Deviation 8.7
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 24 pre-dose
|
-0.4 mmHg
Standard Deviation 7.6
|
-1.6 mmHg
Standard Deviation 7.2
|
-0.7 mmHg
Standard Deviation 9.3
|
1.0 mmHg
Standard Deviation 6.9
|
-1.0 mmHg
Standard Deviation 6.6
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 24 post dose
|
-0.6 mmHg
Standard Deviation 7.5
|
-1.7 mmHg
Standard Deviation 7.9
|
-0.3 mmHg
Standard Deviation 8.2
|
-0.3 mmHg
Standard Deviation 7.6
|
-1.4 mmHg
Standard Deviation 7.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 28 pre-dose
|
1.4 mmHg
Standard Deviation 7.9
|
-0.6 mmHg
Standard Deviation 9.7
|
0.9 mmHg
Standard Deviation 9.5
|
-0.6 mmHg
Standard Deviation 6.9
|
-0.5 mmHg
Standard Deviation 7.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 32 pre-dose
|
0.2 mmHg
Standard Deviation 8.5
|
-1.7 mmHg
Standard Deviation 8.6
|
1.6 mmHg
Standard Deviation 9.2
|
-0.3 mmHg
Standard Deviation 9.3
|
-1.2 mmHg
Standard Deviation 8.6
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 36 post dose
|
1.6 mmHg
Standard Deviation 7.7
|
-1.6 mmHg
Standard Deviation 9.2
|
1.3 mmHg
Standard Deviation 9.3
|
-1.7 mmHg
Standard Deviation 6.8
|
-0.1 mmHg
Standard Deviation 7.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 40 post dose
|
0.9 mmHg
Standard Deviation 7.7
|
-1.8 mmHg
Standard Deviation 9.1
|
0.2 mmHg
Standard Deviation 8.3
|
-0.8 mmHg
Standard Deviation 6.6
|
-0.1 mmHg
Standard Deviation 7.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 44 pre-dose
|
1.4 mmHg
Standard Deviation 9.3
|
-2.1 mmHg
Standard Deviation 7.7
|
1.3 mmHg
Standard Deviation 9.2
|
-0.4 mmHg
Standard Deviation 6.7
|
-2.4 mmHg
Standard Deviation 10.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure 1 hour post dose
|
-0.6 mmHg
Standard Deviation 9.4
|
-2.0 mmHg
Standard Deviation 10.5
|
0.2 mmHg
Standard Deviation 8.7
|
1.0 mmHg
Standard Deviation 8.4
|
-1.8 mmHg
Standard Deviation 7.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 8 post dose
|
-3.2 mmHg
Standard Deviation 12.6
|
-1.9 mmHg
Standard Deviation 11.6
|
-0.3 mmHg
Standard Deviation 11.1
|
-2.8 mmHg
Standard Deviation 10.2
|
-1.9 mmHg
Standard Deviation 12.0
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 12 pre-dose
|
-3.3 mmHg
Standard Deviation 12.4
|
1.6 mmHg
Standard Deviation 13.7
|
-3.1 mmHg
Standard Deviation 11.7
|
-4.4 mmHg
Standard Deviation 10.8
|
-2.6 mmHg
Standard Deviation 9.7
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 12 post dose
|
-3.9 mmHg
Standard Deviation 14.1
|
2.1 mmHg
Standard Deviation 11.1
|
-1.9 mmHg
Standard Deviation 12.0
|
-3.6 mmHg
Standard Deviation 10.1
|
-2.4 mmHg
Standard Deviation 10.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 16 pre-dose
|
-3.6 mmHg
Standard Deviation 15.1
|
-2.3 mmHg
Standard Deviation 12.3
|
-4.3 mmHg
Standard Deviation 11.3
|
-4.3 mmHg
Standard Deviation 12.5
|
-2.3 mmHg
Standard Deviation 11.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 16 post dose
|
-3.7 mmHg
Standard Deviation 17.1
|
-2.6 mmHg
Standard Deviation 11.7
|
-3.4 mmHg
Standard Deviation 12.7
|
-2.7 mmHg
Standard Deviation 11.0
|
-5.7 mmHg
Standard Deviation 8.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 24 post dose
|
-2.6 mmHg
Standard Deviation 10.9
|
-2.8 mmHg
Standard Deviation 10.5
|
-2.2 mmHg
Standard Deviation 11.7
|
-3.0 mmHg
Standard Deviation 9.7
|
-1.1 mmHg
Standard Deviation 10.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure 30 min post dose
|
1.3 mmHg
Standard Deviation 8.9
|
-1.2 mmHg
Standard Deviation 4.9
|
-1.2 mmHg
Standard Deviation 5.4
|
0.6 mmHg
Standard Deviation 6.1
|
-0.6 mmHg
Standard Deviation 5.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure 1 h post dose
|
1.1 mmHg
Standard Deviation 8.8
|
-2.0 mmHg
Standard Deviation 6.3
|
-0.7 mmHg
Standard Deviation 8.1
|
1.2 mmHg
Standard Deviation 6.7
|
-1.0 mmHg
Standard Deviation 5.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 1
|
0.1 mmHg
Standard Deviation 9.6
|
-0.3 mmHg
Standard Deviation 6.5
|
0.6 mmHg
Standard Deviation 11.4
|
-0.9 mmHg
Standard Deviation 6.6
|
-0.4 mmHg
Standard Deviation 6.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 2
|
0.7 mmHg
Standard Deviation 10.4
|
-0.7 mmHg
Standard Deviation 6.5
|
-1.0 mmHg
Standard Deviation 8.9
|
-2.7 mmHg
Standard Deviation 8.3
|
-0.1 mmHg
Standard Deviation 9.0
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 4 pre-dose
|
0.0 mmHg
Standard Deviation 8.2
|
-1.7 mmHg
Standard Deviation 8.4
|
-1.4 mmHg
Standard Deviation 10.7
|
-0.8 mmHg
Standard Deviation 7.8
|
-1.3 mmHg
Standard Deviation 7.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 4 post dose
|
-2.0 mmHg
Standard Deviation 8.7
|
-1.0 mmHg
Standard Deviation 7.3
|
-1.2 mmHg
Standard Deviation 8.9
|
-0.9 mmHg
Standard Deviation 8.3
|
-1.6 mmHg
Standard Deviation 7.6
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 8 pre-dose
|
1.0 mmHg
Standard Deviation 8.2
|
-1.3 mmHg
Standard Deviation 8.7
|
0.3 mmHg
Standard Deviation 8.7
|
-0.5 mmHg
Standard Deviation 7.0
|
0.2 mmHg
Standard Deviation 6.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 8 post dose
|
-0.9 mmHg
Standard Deviation 9.1
|
-1.1 mmHg
Standard Deviation 8.4
|
0.6 mmHg
Standard Deviation 8.7
|
-0.7 mmHg
Standard Deviation 7.3
|
-2.2 mmHg
Standard Deviation 7.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 12 pre-dose
|
0.2 mmHg
Standard Deviation 9.1
|
-1.1 mmHg
Standard Deviation 10.4
|
0.2 mmHg
Standard Deviation 8.5
|
-1.5 mmHg
Standard Deviation 7.9
|
-0.6 mmHg
Standard Deviation 8.2
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 16 pre-dose
|
-2.7 mmHg
Standard Deviation 9.6
|
-3.5 mmHg
Standard Deviation 8.9
|
-0.8 mmHg
Standard Deviation 8.6
|
-1.2 mmHg
Standard Deviation 8.7
|
-0.4 mmHg
Standard Deviation 7.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 20 pre-dose
|
0.5 mmHg
Standard Deviation 10.3
|
-1.8 mmHg
Standard Deviation 9.0
|
-0.6 mmHg
Standard Deviation 8.3
|
-1.4 mmHg
Standard Deviation 8.3
|
-1.8 mmHg
Standard Deviation 7.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 20 post dose
|
0.1 mmHg
Standard Deviation 9.5
|
-3.1 mmHg
Standard Deviation 8.3
|
-0.4 mmHg
Standard Deviation 9.2
|
-3.0 mmHg
Standard Deviation 9.3
|
-2.6 mmHg
Standard Deviation 7.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 28 post dose
|
1.2 mmHg
Standard Deviation 8.7
|
-2.0 mmHg
Standard Deviation 9.4
|
1.2 mmHg
Standard Deviation 9.0
|
-0.2 mmHg
Standard Deviation 7.1
|
-1.8 mmHg
Standard Deviation 7.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 32 post dose
|
0.7 mmHg
Standard Deviation 10.0
|
-3.0 mmHg
Standard Deviation 8.6
|
0.1 mmHg
Standard Deviation 9.6
|
-0.6 mmHg
Standard Deviation 8.5
|
-2.1 mmHg
Standard Deviation 8.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 36 pre-dose
|
0.0 mmHg
Standard Deviation 8.6
|
-0.6 mmHg
Standard Deviation 9.2
|
1.4 mmHg
Standard Deviation 8.9
|
-0.9 mmHg
Standard Deviation 7.2
|
0.8 mmHg
Standard Deviation 7.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 40 pre-dose
|
0.8 mmHg
Standard Deviation 7.6
|
-2.5 mmHg
Standard Deviation 9.7
|
1.0 mmHg
Standard Deviation 9.5
|
-1.0 mmHg
Standard Deviation 7.2
|
-1.9 mmHg
Standard Deviation 6.8
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 44 post dose
|
2.3 mmHg
Standard Deviation 9.2
|
-1.3 mmHg
Standard Deviation 7.6
|
-0.7 mmHg
Standard Deviation 8.7
|
-1.4 mmHg
Standard Deviation 8.1
|
-1.5 mmHg
Standard Deviation 6.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic Blood Pressure Week 48
|
1.8 mmHg
Standard Deviation 9.2
|
0.4 mmHg
Standard Deviation 9.7
|
1.1 mmHg
Standard Deviation 9.1
|
0.6 mmHg
Standard Deviation 8.7
|
-0.8 mmHg
Standard Deviation 6.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure 30 min post dose
|
0.8 mmHg
Standard Deviation 8.1
|
0.5 mmHg
Standard Deviation 9.7
|
-0.8 mmHg
Standard Deviation 8.2
|
1.5 mmHg
Standard Deviation 8.8
|
-2.5 mmHg
Standard Deviation 9.7
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 1
|
-1.7 mmHg
Standard Deviation 10.8
|
-1.3 mmHg
Standard Deviation 10.0
|
1.7 mmHg
Standard Deviation 12.9
|
-2.4 mmHg
Standard Deviation 8.3
|
-1.6 mmHg
Standard Deviation 11.0
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 2
|
-0.7 mmHg
Standard Deviation 12.9
|
-0.2 mmHg
Standard Deviation 9.8
|
-0.1 mmHg
Standard Deviation 13.2
|
-2.7 mmHg
Standard Deviation 8.2
|
-0.4 mmHg
Standard Deviation 11.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 4 pre-dose
|
-2.6 mmHg
Standard Deviation 11.4
|
-1.5 mmHg
Standard Deviation 10.6
|
-1.0 mmHg
Standard Deviation 13.0
|
-2.3 mmHg
Standard Deviation 10.5
|
-2.7 mmHg
Standard Deviation 11.2
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 4 post dose
|
-3.5 mmHg
Standard Deviation 12.1
|
-0.6 mmHg
Standard Deviation 10.4
|
-2.2 mmHg
Standard Deviation 11.8
|
-0.6 mmHg
Standard Deviation 9.1
|
-3.7 mmHg
Standard Deviation 11.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 8 pre-dose
|
-2.1 mmHg
Standard Deviation 13.1
|
-0.8 mmHg
Standard Deviation 10.7
|
-1.1 mmHg
Standard Deviation 11.3
|
-3.6 mmHg
Standard Deviation 11.7
|
-1.3 mmHg
Standard Deviation 10.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 20 pre-dose
|
-2.0 mmHg
Standard Deviation 13.1
|
-3.2 mmHg
Standard Deviation 12.5
|
-2.6 mmHg
Standard Deviation 11.9
|
-5.4 mmHg
Standard Deviation 9.7
|
-4.5 mmHg
Standard Deviation 10.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 20 post dose
|
-1.9 mmHg
Standard Deviation 14.5
|
-3.2 mmHg
Standard Deviation 13.0
|
-3.7 mmHg
Standard Deviation 12.2
|
-7.9 mmHg
Standard Deviation 11.9
|
-4.4 mmHg
Standard Deviation 9.9
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 24 pre-dose
|
-3.1 mmHg
Standard Deviation 10.5
|
-1.1 mmHg
Standard Deviation 9.5
|
-2.7 mmHg
Standard Deviation 12.3
|
-3.6 mmHg
Standard Deviation 10.1
|
-0.3 mmHg
Standard Deviation 10.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 28 pre-dose
|
-0.1 mmHg
Standard Deviation 11.4
|
-2.5 mmHg
Standard Deviation 12.8
|
-2.5 mmHg
Standard Deviation 13.1
|
0.4 mmHg
Standard Deviation 11.6
|
-2.9 mmHg
Standard Deviation 11.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 28 post dose
|
-1.1 mmHg
Standard Deviation 12.1
|
-2.9 mmHg
Standard Deviation 11.1
|
-2.6 mmHg
Standard Deviation 12.4
|
-0.7 mmHg
Standard Deviation 11.9
|
-4.6 mmHg
Standard Deviation 11.2
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 32 pre-dose
|
-0.9 mmHg
Standard Deviation 13.1
|
-1.5 mmHg
Standard Deviation 13.3
|
-0.6 mmHg
Standard Deviation 12.4
|
0.6 mmHg
Standard Deviation 11.0
|
-3.7 mmHg
Standard Deviation 12.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 32 post dose
|
-1.7 mmHg
Standard Deviation 12.6
|
-2.2 mmHg
Standard Deviation 11.6
|
0.3 mmHg
Standard Deviation 12.5
|
-0.4 mmHg
Standard Deviation 11.1
|
-4.8 mmHg
Standard Deviation 10.6
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 36 pre-dose
|
-3.1 mmHg
Standard Deviation 11.9
|
1.1 mmHg
Standard Deviation 13.9
|
-0.2 mmHg
Standard Deviation 13.6
|
-1.8 mmHg
Standard Deviation 11.2
|
-3.2 mmHg
Standard Deviation 11.1
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 36 post dose
|
-0.6 mmHg
Standard Deviation 11.1
|
1.3 mmHg
Standard Deviation 12.6
|
-0.5 mmHg
Standard Deviation 12.4
|
-3.8 mmHg
Standard Deviation 10.8
|
-3.8 mmHg
Standard Deviation 11.4
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 40 pre-dose
|
-3.3 mmHg
Standard Deviation 12.1
|
-3.1 mmHg
Standard Deviation 11.4
|
-1.6 mmHg
Standard Deviation 12.9
|
-4.0 mmHg
Standard Deviation 9.5
|
-1.2 mmHg
Standard Deviation 11.0
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 40 post dose
|
-2.3 mmHg
Standard Deviation 11.7
|
-0.4 mmHg
Standard Deviation 12.7
|
-1.2 mmHg
Standard Deviation 13.8
|
-3.2 mmHg
Standard Deviation 11.6
|
-2.2 mmHg
Standard Deviation 9.6
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 44 pre-dose
|
-2.8 mmHg
Standard Deviation 12.3
|
-2.8 mmHg
Standard Deviation 9.9
|
0.0 mmHg
Standard Deviation 13.1
|
-5.1 mmHg
Standard Deviation 9.9
|
-3.9 mmHg
Standard Deviation 10.3
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 44 post dose
|
-1.8 mmHg
Standard Deviation 14.5
|
-1.2 mmHg
Standard Deviation 9.5
|
-0.6 mmHg
Standard Deviation 10.4
|
-4.6 mmHg
Standard Deviation 10.3
|
-3.8 mmHg
Standard Deviation 10.5
|
|
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Systolic Blood Pressure Week 48
|
-1.1 mmHg
Standard Deviation 14.0
|
-0.1 mmHg
Standard Deviation 12.5
|
-0.1 mmHg
Standard Deviation 12.6
|
-2.8 mmHg
Standard Deviation 11.5
|
-5.2 mmHg
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Pulse rate was measured in beats per minute (beats/min).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 12 pre-dose
|
1.1 beats/min
Standard Deviation 10.2
|
-2.2 beats/min
Standard Deviation 8.5
|
-2.9 beats/min
Standard Deviation 10.5
|
-1.7 beats/min
Standard Deviation 9.5
|
-1.1 beats/min
Standard Deviation 8.4
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 1
|
2.9 beats/min
Standard Deviation 8.3
|
-1.5 beats/min
Standard Deviation 7.5
|
-0.7 beats/min
Standard Deviation 7.1
|
0.6 beats/min
Standard Deviation 8.9
|
-0.8 beats/min
Standard Deviation 9.0
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 4 post dose
|
0.4 beats/min
Standard Deviation 8.6
|
-2.6 beats/min
Standard Deviation 6.6
|
-2.7 beats/min
Standard Deviation 9.5
|
-0.5 beats/min
Standard Deviation 9.4
|
-1.1 beats/min
Standard Deviation 6.2
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 8 pre-dose
|
0.9 beats/min
Standard Deviation 6.5
|
-0.6 beats/min
Standard Deviation 8.0
|
-1.6 beats/min
Standard Deviation 8.6
|
0.8 beats/min
Standard Deviation 6.9
|
-1.3 beats/min
Standard Deviation 8.2
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 8 post dose
|
-0.1 beats/min
Standard Deviation 6.9
|
-1.3 beats/min
Standard Deviation 8.6
|
-1.9 beats/min
Standard Deviation 8.6
|
0.0 beats/min
Standard Deviation 8.5
|
-2.3 beats/min
Standard Deviation 8.3
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 16 post dose
|
-0.1 beats/min
Standard Deviation 9.9
|
-3.5 beats/min
Standard Deviation 5.5
|
-3.7 beats/min
Standard Deviation 9.7
|
-2.1 beats/min
Standard Deviation 9.8
|
-2.2 beats/min
Standard Deviation 7.3
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 24 pre-dose
|
-0.5 beats/min
Standard Deviation 7.9
|
-2.0 beats/min
Standard Deviation 8.1
|
-2.8 beats/min
Standard Deviation 10.4
|
-0.7 beats/min
Standard Deviation 7.3
|
-1.2 beats/min
Standard Deviation 7.8
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 28 pre-dose
|
1.9 beats/min
Standard Deviation 9.7
|
-2.1 beats/min
Standard Deviation 10.0
|
0.0 beats/min
Standard Deviation 9.3
|
-0.5 beats/min
Standard Deviation 11.2
|
0.2 beats/min
Standard Deviation 8.3
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 36 pre-dose
|
0.7 beats/min
Standard Deviation 8.5
|
0.2 beats/min
Standard Deviation 7.5
|
-2.6 beats/min
Standard Deviation 8.6
|
-2.6 beats/min
Standard Deviation 10.2
|
-0.5 beats/min
Standard Deviation 9.7
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 36 post dose
|
1.1 beats/min
Standard Deviation 7.6
|
-0.8 beats/min
Standard Deviation 8.2
|
-3.0 beats/min
Standard Deviation 9.8
|
-2.5 beats/min
Standard Deviation 8.2
|
-1.4 beats/min
Standard Deviation 9.6
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
30 min post dose
|
0.4 beats/min
Standard Deviation 5.4
|
-0.8 beats/min
Standard Deviation 5.6
|
-1.5 beats/min
Standard Deviation 7.2
|
-2.3 beats/min
Standard Deviation 7.5
|
-1.1 beats/min
Standard Deviation 7.2
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
1 hour post dose
|
0.3 beats/min
Standard Deviation 6.7
|
1.0 beats/min
Standard Deviation 11.3
|
-0.8 beats/min
Standard Deviation 7.6
|
-0.8 beats/min
Standard Deviation 8.1
|
-0.4 beats/min
Standard Deviation 7.0
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 2
|
1.2 beats/min
Standard Deviation 6.4
|
-1.7 beats/min
Standard Deviation 5.7
|
-0.7 beats/min
Standard Deviation 7.9
|
-1.0 beats/min
Standard Deviation 9.1
|
-0.4 beats/min
Standard Deviation 6.9
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 4 pre-dose
|
-0.2 beats/min
Standard Deviation 5.3
|
-2.1 beats/min
Standard Deviation 6.9
|
-1.9 beats/min
Standard Deviation 8.1
|
0.1 beats/min
Standard Deviation 9.8
|
-1.0 beats/min
Standard Deviation 6.6
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 12 post dose
|
-0.6 beats/min
Standard Deviation 8.8
|
-3.3 beats/min
Standard Deviation 8.8
|
-3.6 beats/min
Standard Deviation 9.4
|
-2.1 beats/min
Standard Deviation 9.7
|
-2.0 beats/min
Standard Deviation 7.8
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 16 pre-dose
|
-0.2 beats/min
Standard Deviation 8.5
|
-2.1 beats/min
Standard Deviation 5.8
|
-2.9 beats/min
Standard Deviation 8.0
|
-1.9 beats/min
Standard Deviation 10.1
|
-1.3 beats/min
Standard Deviation 7.2
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 20 pre-dose
|
-0.1 beats/min
Standard Deviation 10.3
|
-2.4 beats/min
Standard Deviation 7.0
|
-1.7 beats/min
Standard Deviation 10.3
|
0.0 beats/min
Standard Deviation 9.0
|
-1.2 beats/min
Standard Deviation 9.0
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 20 post dose
|
-0.7 beats/min
Standard Deviation 6.8
|
-2.3 beats/min
Standard Deviation 7.8
|
-2.1 beats/min
Standard Deviation 9.7
|
-0.1 beats/min
Standard Deviation 8.5
|
-1.3 beats/min
Standard Deviation 8.9
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 24 post dose
|
-0.9 beats/min
Standard Deviation 7.8
|
-2.9 beats/min
Standard Deviation 8.5
|
-3.0 beats/min
Standard Deviation 9.6
|
-1.3 beats/min
Standard Deviation 6.9
|
-2.5 beats/min
Standard Deviation 7.1
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 28 post dose
|
1.8 beats/min
Standard Deviation 7.5
|
-3.0 beats/min
Standard Deviation 9.4
|
-0.5 beats/min
Standard Deviation 8.5
|
-0.8 beats/min
Standard Deviation 10.0
|
0.0 beats/min
Standard Deviation 7.5
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 32 pre-dose
|
3.3 beats/min
Standard Deviation 10.0
|
-0.9 beats/min
Standard Deviation 7.9
|
-2.0 beats/min
Standard Deviation 9.2
|
-1.2 beats/min
Standard Deviation 10.6
|
-0.3 beats/min
Standard Deviation 7.8
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 32 post dose
|
3.3 beats/min
Standard Deviation 8.4
|
-0.8 beats/min
Standard Deviation 7.8
|
-3.0 beats/min
Standard Deviation 9.5
|
-1.9 beats/min
Standard Deviation 9.6
|
-2.0 beats/min
Standard Deviation 8.8
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 40 pre-dose
|
2.7 beats/min
Standard Deviation 10.3
|
-0.5 beats/min
Standard Deviation 8.8
|
1.0 beats/min
Standard Deviation 10.1
|
-1.7 beats/min
Standard Deviation 7.6
|
2.0 beats/min
Standard Deviation 9.4
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 40 post dose
|
0.9 beats/min
Standard Deviation 8.3
|
-1.7 beats/min
Standard Deviation 8.3
|
0.0 beats/min
Standard Deviation 8.9
|
-2.0 beats/min
Standard Deviation 8.4
|
0.5 beats/min
Standard Deviation 9.1
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 44 pre-dose
|
2.2 beats/min
Standard Deviation 8.9
|
-1.6 beats/min
Standard Deviation 6.9
|
-0.4 beats/min
Standard Deviation 10.1
|
-1.4 beats/min
Standard Deviation 8.2
|
0.7 beats/min
Standard Deviation 9.7
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 44 post dose
|
2.9 beats/min
Standard Deviation 6.9
|
-1.7 beats/min
Standard Deviation 8.0
|
-0.5 beats/min
Standard Deviation 11.0
|
-2.8 beats/min
Standard Deviation 7.7
|
-0.2 beats/min
Standard Deviation 10.3
|
|
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Week 48
|
2.0 beats/min
Standard Deviation 8.9
|
-3.7 beats/min
Standard Deviation 7.8
|
-2.5 beats/min
Standard Deviation 10.4
|
-4.2 beats/min
Standard Deviation 9.5
|
-3.1 beats/min
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Overall number of participants analyzed include only those for whom body weight was measured and analyzed during the study.
Body weight was measured in kilograms.
Outcome measures
| Measure |
Placebo (FAS)
n=41 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=38 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Body Weight During the Study
Week 12
|
0.14 kilograms
Standard Deviation 3.38
|
-0.87 kilograms
Standard Deviation 3.12
|
0.21 kilograms
Standard Deviation 1.78
|
-0.38 kilograms
Standard Deviation 1.80
|
-0.04 kilograms
Standard Deviation 2.39
|
|
Changes From Baseline in Body Weight During the Study
Week 24
|
0.33 kilograms
Standard Deviation 4.10
|
-0.03 kilograms
Standard Deviation 3.48
|
-0.07 kilograms
Standard Deviation 2.63
|
-0.13 kilograms
Standard Deviation 2.37
|
-0.39 kilograms
Standard Deviation 3.73
|
|
Changes From Baseline in Body Weight During the Study
Week 36
|
0.32 kilograms
Standard Deviation 5.15
|
-0.14 kilograms
Standard Deviation 2.90
|
0.27 kilograms
Standard Deviation 3.42
|
0.15 kilograms
Standard Deviation 2.36
|
-0.04 kilograms
Standard Deviation 4.19
|
|
Changes From Baseline in Body Weight During the Study
Week 48
|
0.21 kilograms
Standard Deviation 4.42
|
0.45 kilograms
Standard Deviation 3.41
|
0.80 kilograms
Standard Deviation 3.84
|
-0.14 kilograms
Standard Deviation 3.32
|
0.11 kilograms
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Overall number of participants analyzed include only those for whom electrocardiogram data was measured and analyzed during the study.
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
Outcome measures
| Measure |
Placebo (FAS)
n=40 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=38 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=42 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=36 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QTcB Week 12
|
3.4 msec
Standard Deviation 32.7
|
-2.8 msec
Standard Deviation 29.9
|
-5.6 msec
Standard Deviation 41.8
|
1.5 msec
Standard Deviation 18.2
|
-1.9 msec
Standard Deviation 31.4
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QT Week 12
|
-2.0 msec
Standard Deviation 46.6
|
1.7 msec
Standard Deviation 34.0
|
9.5 msec
Standard Deviation 21.4
|
3.8 msec
Standard Deviation 25.6
|
11.5 msec
Standard Deviation 80.8
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
RR Week 12
|
3.3 msec
Standard Deviation 99.3
|
-22.5 msec
Standard Deviation 212.6
|
75.8 msec
Standard Deviation 179.3
|
11.0 msec
Standard Deviation 125.1
|
-17.0 msec
Standard Deviation 182.1
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QTcB Week 48
|
-2.5 msec
Standard Deviation 34.8
|
-5.8 msec
Standard Deviation 36.5
|
-5.9 msec
Standard Deviation 22.2
|
-4.7 msec
Standard Deviation 21.0
|
-5.7 msec
Standard Deviation 27.7
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QTcF Week 12
|
4.5 msec
Standard Deviation 27.5
|
-2.5 msec
Standard Deviation 22.4
|
-2.2 msec
Standard Deviation 14.2
|
-0.5 msec
Standard Deviation 17.0
|
-3.0 msec
Standard Deviation 18.8
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QTcF Week 48
|
-0.1 msec
Standard Deviation 30.7
|
-6.1 msec
Standard Deviation 31.4
|
-0.2 msec
Standard Deviation 15.6
|
-2.2 msec
Standard Deviation 20.0
|
4.6 msec
Standard Deviation 44.6
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
PR Week 12
|
-1.7 msec
Standard Deviation 23.3
|
-1.0 msec
Standard Deviation 23.7
|
-19.6 msec
Standard Deviation 102.1
|
3.2 msec
Standard Deviation 18.2
|
-9.5 msec
Standard Deviation 32.3
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
PR Week 48
|
2.6 msec
Standard Deviation 33.7
|
17.5 msec
Standard Deviation 128.8
|
4.0 msec
Standard Deviation 163.0
|
0.8 msec
Standard Deviation 18.9
|
-2.8 msec
Standard Deviation 26.5
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QRS Week 12
|
2.6 msec
Standard Deviation 22.3
|
-2.9 msec
Standard Deviation 10.8
|
-1.8 msec
Standard Deviation 7.6
|
-0.2 msec
Standard Deviation 5.4
|
6.1 msec
Standard Deviation 42.8
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QRS Week 48
|
5.6 msec
Standard Deviation 21.4
|
-1.5 msec
Standard Deviation 16.1
|
-4.0 msec
Standard Deviation 13.0
|
0.6 msec
Standard Deviation 16.2
|
0.1 msec
Standard Deviation 18.7
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
QT Week 48
|
-0.7 msec
Standard Deviation 33.4
|
3.1 msec
Standard Deviation 29.9
|
3.9 msec
Standard Deviation 22.8
|
5.4 msec
Standard Deviation 26.7
|
0.7 msec
Standard Deviation 31.6
|
|
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
RR Week 48
|
-0.6 msec
Standard Deviation 116.1
|
11.9 msec
Standard Deviation 187.1
|
65.2 msec
Standard Deviation 139.0
|
44.3 msec
Standard Deviation 124.0
|
25.1 msec
Standard Deviation 148.5
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10\^9/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 20
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0.036 10^9 white blood cells per liter
Standard Deviation 0.1038
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0.026 10^9 white blood cells per liter
Standard Deviation 0.1186
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0.024 10^9 white blood cells per liter
Standard Deviation 0.1157
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-0.014 10^9 white blood cells per liter
Standard Deviation 0.1228
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0.038 10^9 white blood cells per liter
Standard Deviation 0.0935
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 24
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0.031 10^9 white blood cells per liter
Standard Deviation 0.1301
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0.013 10^9 white blood cells per liter
Standard Deviation 0.0844
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0.058 10^9 white blood cells per liter
Standard Deviation 0.2111
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-0.019 10^9 white blood cells per liter
Standard Deviation 0.1238
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0.037 10^9 white blood cells per liter
Standard Deviation 0.1192
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 28
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0.036 10^9 white blood cells per liter
Standard Deviation 0.0986
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0.018 10^9 white blood cells per liter
Standard Deviation 0.0926
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0.053 10^9 white blood cells per liter
Standard Deviation 0.1826
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-0.000 10^9 white blood cells per liter
Standard Deviation 0.1213
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0.025 10^9 white blood cells per liter
Standard Deviation 0.0870
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 32
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0.049 10^9 white blood cells per liter
Standard Deviation 0.1502
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0.033 10^9 white blood cells per liter
Standard Deviation 0.0838
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0.020 10^9 white blood cells per liter
Standard Deviation 0.1418
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0.024 10^9 white blood cells per liter
Standard Deviation 0.1577
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0.041 10^9 white blood cells per liter
Standard Deviation 0.1141
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 1
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0387
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0329
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-0.002 10^9 white blood cells per liter
Standard Deviation 0.0408
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0.007 10^9 white blood cells per liter
Standard Deviation 0.0264
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0.008 10^9 white blood cells per liter
Standard Deviation 0.0350
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 4
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0.002 10^9 white blood cells per liter
Standard Deviation 0.0474
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0324
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-0.007 10^9 white blood cells per liter
Standard Deviation 0.0463
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0312
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0312
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 8
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-0.002 10^9 white blood cells per liter
Standard Deviation 0.0353
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0229
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-0.005 10^9 white blood cells per liter
Standard Deviation 0.0384
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0.003 10^9 white blood cells per liter
Standard Deviation 0.0367
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0.002 10^9 white blood cells per liter
Standard Deviation 0.0418
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 12
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0.002 10^9 white blood cells per liter
Standard Deviation 0.0353
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0.003 10^9 white blood cells per liter
Standard Deviation 0.0280
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-0.002 10^9 white blood cells per liter
Standard Deviation 0.0462
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0329
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0.010 10^9 white blood cells per liter
Standard Deviation 0.0374
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 16
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0.010 10^9 white blood cells per liter
Standard Deviation 0.0431
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0324
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-0.007 10^9 white blood cells per liter
Standard Deviation 0.0463
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0329
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0.008 10^9 white blood cells per liter
Standard Deviation 0.0417
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 20
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-0.003 10^9 white blood cells per liter
Standard Deviation 0.0362
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0.003 10^9 white blood cells per liter
Standard Deviation 0.0362
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0500
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0329
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0397
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 40
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0.003 10^9 white blood cells per liter
Standard Deviation 0.0506
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0399
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-0.010 10^9 white blood cells per liter
Standard Deviation 0.0379
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0.006 10^9 white blood cells per liter
Standard Deviation 0.0343
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0403
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 44
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0.006 10^9 white blood cells per liter
Standard Deviation 0.0410
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0.003 10^9 white blood cells per liter
Standard Deviation 0.0372
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0387
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0.006 10^9 white blood cells per liter
Standard Deviation 0.0422
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0.000 10^9 white blood cells per liter
Standard Deviation 0.0338
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 8
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0.024 10^9 white blood cells per liter
Standard Deviation 0.0969
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-0.003 10^9 white blood cells per liter
Standard Deviation 0.0707
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0.000 10^9 white blood cells per liter
Standard Deviation 0.1000
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0.008 10^9 white blood cells per liter
Standard Deviation 0.0941
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0.005 10^9 white blood cells per liter
Standard Deviation 0.0669
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 12
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0.020 10^9 white blood cells per liter
Standard Deviation 0.0954
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0.010 10^9 white blood cells per liter
Standard Deviation 0.0882
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0.002 10^9 white blood cells per liter
Standard Deviation 0.0831
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-0.026 10^9 white blood cells per liter
Standard Deviation 0.1155
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0.017 10^9 white blood cells per liter
Standard Deviation 0.0704
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 40
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0.050 10^9 white blood cells per liter
Standard Deviation 0.1444
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0.018 10^9 white blood cells per liter
Standard Deviation 0.0865
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0.018 10^9 white blood cells per liter
Standard Deviation 0.0958
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0.015 10^9 white blood cells per liter
Standard Deviation 0.1971
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0.039 10^9 white blood cells per liter
Standard Deviation 0.1128
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 44
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0.072 10^9 white blood cells per liter
Standard Deviation 0.1523
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0.019 10^9 white blood cells per liter
Standard Deviation 0.0908
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0.024 10^9 white blood cells per liter
Standard Deviation 0.0994
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-0.009 10^9 white blood cells per liter
Standard Deviation 0.1798
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0.006 10^9 white blood cells per liter
Standard Deviation 0.0893
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 48
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0.045 10^9 white blood cells per liter
Standard Deviation 0.1811
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0.006 10^9 white blood cells per liter
Standard Deviation 0.0754
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0.023 10^9 white blood cells per liter
Standard Deviation 0.0891
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0.009 10^9 white blood cells per liter
Standard Deviation 0.2833
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-0.005 10^9 white blood cells per liter
Standard Deviation 0.0857
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 1
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-0.271 10^9 white blood cells per liter
Standard Deviation 1.1885
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-0.597 10^9 white blood cells per liter
Standard Deviation 1.1490
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-0.656 10^9 white blood cells per liter
Standard Deviation 1.2593
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-1.029 10^9 white blood cells per liter
Standard Deviation 1.6496
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-0.285 10^9 white blood cells per liter
Standard Deviation 1.6896
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 8
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0.429 10^9 white blood cells per liter
Standard Deviation 1.7036
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-0.333 10^9 white blood cells per liter
Standard Deviation 1.4014
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-0.185 10^9 white blood cells per liter
Standard Deviation 1.2889
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-1.071 10^9 white blood cells per liter
Standard Deviation 1.9639
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-0.629 10^9 white blood cells per liter
Standard Deviation 1.5489
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 16
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-0.400 10^9 white blood cells per liter
Standard Deviation 1.5616
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-0.839 10^9 white blood cells per liter
Standard Deviation 1.8179
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-0.590 10^9 white blood cells per liter
Standard Deviation 1.4668
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-1.318 10^9 white blood cells per liter
Standard Deviation 2.3324
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-0.293 10^9 white blood cells per liter
Standard Deviation 1.8427
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 20
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-0.936 10^9 white blood cells per liter
Standard Deviation 1.2756
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-1.100 10^9 white blood cells per liter
Standard Deviation 1.5599
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-0.432 10^9 white blood cells per liter
Standard Deviation 1.3032
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-0.932 10^9 white blood cells per liter
Standard Deviation 2.2832
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-0.455 10^9 white blood cells per liter
Standard Deviation 1.7116
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 24
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-1.251 10^9 white blood cells per liter
Standard Deviation 1.3888
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-0.884 10^9 white blood cells per liter
Standard Deviation 1.7768
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-0.495 10^9 white blood cells per liter
Standard Deviation 1.4216
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-1.119 10^9 white blood cells per liter
Standard Deviation 2.2807
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-0.765 10^9 white blood cells per liter
Standard Deviation 1.8691
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 36
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-0.541 10^9 white blood cells per liter
Standard Deviation 1.5971
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-0.974 10^9 white blood cells per liter
Standard Deviation 1.7389
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-0.366 10^9 white blood cells per liter
Standard Deviation 1.4549
|
-1.082 10^9 white blood cells per liter
Standard Deviation 2.3389
|
-0.126 10^9 white blood cells per liter
Standard Deviation 2.2565
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 40
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-0.783 10^9 white blood cells per liter
Standard Deviation 1.7693
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-0.826 10^9 white blood cells per liter
Standard Deviation 1.5942
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-0.437 10^9 white blood cells per liter
Standard Deviation 1.7878
|
-1.226 10^9 white blood cells per liter
Standard Deviation 2.3856
|
-0.266 10^9 white blood cells per liter
Standard Deviation 1.7976
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 44
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-1.065 10^9 white blood cells per liter
Standard Deviation 1.6070
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-0.978 10^9 white blood cells per liter
Standard Deviation 1.8151
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-0.537 10^9 white blood cells per liter
Standard Deviation 1.5641
|
-1.032 10^9 white blood cells per liter
Standard Deviation 2.1585
|
-0.825 10^9 white blood cells per liter
Standard Deviation 1.8917
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 1
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-0.083 10^9 white blood cells per liter
Standard Deviation 0.5074
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-0.024 10^9 white blood cells per liter
Standard Deviation 0.4142
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0.044 10^9 white blood cells per liter
Standard Deviation 0.5039
|
-0.017 10^9 white blood cells per liter
Standard Deviation 0.4189
|
0.020 10^9 white blood cells per liter
Standard Deviation 0.3006
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 2
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0.105 10^9 white blood cells per liter
Standard Deviation 0.3246
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0.026 10^9 white blood cells per liter
Standard Deviation 0.4137
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0.021 10^9 white blood cells per liter
Standard Deviation 0.6006
|
0.007 10^9 white blood cells per liter
Standard Deviation 0.3643
|
0.161 10^9 white blood cells per liter
Standard Deviation 0.4277
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 24
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-0.041 10^9 white blood cells per liter
Standard Deviation 0.3905
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0.050 10^9 white blood cells per liter
Standard Deviation 0.3630
|
0.048 10^9 white blood cells per liter
Standard Deviation 0.4455
|
-0.036 10^9 white blood cells per liter
Standard Deviation 0.3788
|
0.053 10^9 white blood cells per liter
Standard Deviation 0.3974
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 44
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-0.008 10^9 white blood cells per liter
Standard Deviation 0.5390
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0.105 10^9 white blood cells per liter
Standard Deviation 0.4136
|
0.124 10^9 white blood cells per liter
Standard Deviation 0.5366
|
0.115 10^9 white blood cells per liter
Standard Deviation 0.4881
|
0.153 10^9 white blood cells per liter
Standard Deviation 0.4462
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 2
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0.076 10^9 white blood cells per liter
Standard Deviation 0.1358
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-0.011 10^9 white blood cells per liter
Standard Deviation 0.1673
|
0.014 10^9 white blood cells per liter
Standard Deviation 0.1897
|
-0.095 10^9 white blood cells per liter
Standard Deviation 0.2701
|
-0.010 10^9 white blood cells per liter
Standard Deviation 0.1882
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 16
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-0.007 10^9 white blood cells per liter
Standard Deviation 0.1629
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-0.050 10^9 white blood cells per liter
Standard Deviation 0.1673
|
-0.024 10^9 white blood cells per liter
Standard Deviation 0.1265
|
-0.079 10^9 white blood cells per liter
Standard Deviation 0.2384
|
-0.043 10^9 white blood cells per liter
Standard Deviation 0.1752
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 20
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-0.008 10^9 white blood cells per liter
Standard Deviation 0.1783
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-0.041 10^9 white blood cells per liter
Standard Deviation 0.1534
|
-0.015 10^9 white blood cells per liter
Standard Deviation 0.1509
|
-0.081 10^9 white blood cells per liter
Standard Deviation 0.2448
|
-0.003 10^9 white blood cells per liter
Standard Deviation 0.1899
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 24
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-0.026 10^9 white blood cells per liter
Standard Deviation 0.1292
|
-0.034 10^9 white blood cells per liter
Standard Deviation 0.1361
|
0.003 10^9 white blood cells per liter
Standard Deviation 0.1476
|
-0.056 10^9 white blood cells per liter
Standard Deviation 0.2602
|
-0.027 10^9 white blood cells per liter
Standard Deviation 0.1921
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 2
|
-0.026 10^9 white blood cells per liter
Standard Deviation 1.1945
|
-0.418 10^9 white blood cells per liter
Standard Deviation 1.1627
|
-0.337 10^9 white blood cells per liter
Standard Deviation 1.3109
|
-0.880 10^9 white blood cells per liter
Standard Deviation 1.8457
|
-0.537 10^9 white blood cells per liter
Standard Deviation 1.3989
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 4
|
-0.102 10^9 white blood cells per liter
Standard Deviation 1.0044
|
-0.405 10^9 white blood cells per liter
Standard Deviation 1.1246
|
-0.290 10^9 white blood cells per liter
Standard Deviation 1.3463
|
-0.924 10^9 white blood cells per liter
Standard Deviation 1.9975
|
-0.732 10^9 white blood cells per liter
Standard Deviation 1.4028
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 40
|
-1.006 10^9 white blood cells per liter
Standard Deviation 1.7393
|
-0.992 10^9 white blood cells per liter
Standard Deviation 1.4740
|
-0.575 10^9 white blood cells per liter
Standard Deviation 1.9567
|
-1.229 10^9 white blood cells per liter
Standard Deviation 2.4065
|
-0.495 10^9 white blood cells per liter
Standard Deviation 1.5857
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 2
|
0.002 10^9 white blood cells per liter
Standard Deviation 0.0269
|
0.003 10^9 white blood cells per liter
Standard Deviation 0.0283
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0488
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0316
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0384
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 24
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0397
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0324
|
-0.003 10^9 white blood cells per liter
Standard Deviation 0.0530
|
0.008 10^9 white blood cells per liter
Standard Deviation 0.0368
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0389
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 28
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0394
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0329
|
0.008 10^9 white blood cells per liter
Standard Deviation 0.0526
|
0.011 10^9 white blood cells per liter
Standard Deviation 0.0323
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0450
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 32
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0324
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0320
|
-0.010 10^9 white blood cells per liter
Standard Deviation 0.0441
|
0.009 10^9 white blood cells per liter
Standard Deviation 0.0379
|
0.010 10^9 white blood cells per liter
Standard Deviation 0.0384
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 36
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0408
|
0.003 10^9 white blood cells per liter
Standard Deviation 0.0283
|
-0.002 10^9 white blood cells per liter
Standard Deviation 0.0474
|
0.012 10^9 white blood cells per liter
Standard Deviation 0.0415
|
0.013 10^9 white blood cells per liter
Standard Deviation 0.0409
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils Week 48
|
-0.005 10^9 white blood cells per liter
Standard Deviation 0.0462
|
0.003 10^9 white blood cells per liter
Standard Deviation 0.291
|
-0.010 10^9 white blood cells per liter
Standard Deviation 0.0441
|
0.006 10^9 white blood cells per liter
Standard Deviation 0.0354
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.0324
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 1
|
0.010 10^9 white blood cells per liter
Standard Deviation 0.0860
|
0.016 10^9 white blood cells per liter
Standard Deviation 0.0718
|
-0.002 10^9 white blood cells per liter
Standard Deviation 0.0801
|
-0.005 10^9 white blood cells per liter
Standard Deviation 0.0999
|
0.017 10^9 white blood cells per liter
Standard Deviation 0.0636
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 2
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0731
|
0.013 10^9 white blood cells per liter
Standard Deviation 0.0777
|
0.002 10^9 white blood cells per liter
Standard Deviation 0.0913
|
0.002 10^9 white blood cells per liter
Standard Deviation 0.0880
|
0.029 10^9 white blood cells per liter
Standard Deviation 0.0929
|
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Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 4
|
0.002 10^9 white blood cells per liter
Standard Deviation 0.0987
|
0.016 10^9 white blood cells per liter
Standard Deviation 0.0594
|
0.002 10^9 white blood cells per liter
Standard Deviation 0.0780
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.0999
|
0.027 10^9 white blood cells per liter
Standard Deviation 0.0895
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 16
|
0.045 10^9 white blood cells per liter
Standard Deviation 0.1253
|
0.021 10^9 white blood cells per liter
Standard Deviation 0.0935
|
0.010 10^9 white blood cells per liter
Standard Deviation 0.0759
|
-0.005 10^9 white blood cells per liter
Standard Deviation 0.1559
|
0.033 10^9 white blood cells per liter
Standard Deviation 0.0829
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Eosinophils Week 36
|
0.054 10^9 white blood cells per liter
Standard Deviation 0.1726
|
0.018 10^9 white blood cells per liter
Standard Deviation 0.0955
|
0.022 10^9 white blood cells per liter
Standard Deviation 0.0909
|
0.027 10^9 white blood cells per liter
Standard Deviation 0.1526
|
0.015 10^9 white blood cells per liter
Standard Deviation 0.0961
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 2
|
0.157 10^9 white blood cells per liter
Standard Deviation 1.3195
|
-0.131 10^9 white blood cells per liter
Standard Deviation 2.1769
|
-0.309 10^9 white blood cells per liter
Standard Deviation 1.3735
|
-0.954 10^9 white blood cells per liter
Standard Deviation 2.0441
|
-0.322 10^9 white blood cells per liter
Standard Deviation 1.5501
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 4
|
-0.049 10^9 white blood cells per liter
Standard Deviation 1.1938
|
-0.411 10^9 white blood cells per liter
Standard Deviation 1.1988
|
-0.336 10^9 white blood cells per liter
Standard Deviation 1.5088
|
-1.017 10^9 white blood cells per liter
Standard Deviation 1.9397
|
-0.656 10^9 white blood cells per liter
Standard Deviation 1.4264
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 12
|
0.190 10^9 white blood cells per liter
Standard Deviation 1.6223
|
-0.438 10^9 white blood cells per liter
Standard Deviation 1.3854
|
-0.495 10^9 white blood cells per liter
Standard Deviation 1.6904
|
-0.997 10^9 white blood cells per liter
Standard Deviation 2.1806
|
-0.634 10^9 white blood cells per liter
Standard Deviation 1.6084
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 28
|
-0.700 10^9 white blood cells per liter
Standard Deviation 1.8180
|
-0.316 10^9 white blood cells per liter
Standard Deviation 2.3086
|
-0.100 10^9 white blood cells per liter
Standard Deviation 1.4942
|
-0.894 10^9 white blood cells per liter
Standard Deviation 1.7119
|
-0.342 10^9 white blood cells per liter
Standard Deviation 1.5683
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 32
|
-0.762 10^9 white blood cells per liter
Standard Deviation 1.4273
|
-0.862 10^9 white blood cells per liter
Standard Deviation 2.0091
|
-0.330 10^9 white blood cells per liter
Standard Deviation 1.5750
|
-0.918 10^9 white blood cells per liter
Standard Deviation 2.6184
|
-0.505 10^9 white blood cells per liter
Standard Deviation 1.4800
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Leukocytes Week 48
|
-0.739 10^9 white blood cells per liter
Standard Deviation 1.7774
|
-0.869 10^9 white blood cells per liter
Standard Deviation 1.7109
|
-0.473 10^9 white blood cells per liter
Standard Deviation 1.7104
|
-1.225 10^9 white blood cells per liter
Standard Deviation 2.5952
|
-0.777 10^9 white blood cells per liter
Standard Deviation 1.8593
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 4
|
0.037 10^9 white blood cells per liter
Standard Deviation 0.4386
|
0.024 10^9 white blood cells per liter
Standard Deviation 0.3259
|
0.010 10^9 white blood cells per liter
Standard Deviation 0.6003
|
-0.032 10^9 white blood cells per liter
Standard Deviation 0.3996
|
0.095 10^9 white blood cells per liter
Standard Deviation 0.3263
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 8
|
0.120 10^9 white blood cells per liter
Standard Deviation 0.3776
|
0.054 10^9 white blood cells per liter
Standard Deviation 0.3783
|
0.063 10^9 white blood cells per liter
Standard Deviation 0.5928
|
0.053 10^9 white blood cells per liter
Standard Deviation 0.4980
|
0.129 10^9 white blood cells per liter
Standard Deviation 0.3939
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 12
|
0.041 10^9 white blood cells per liter
Standard Deviation 0.3647
|
0.051 10^9 white blood cells per liter
Standard Deviation 0.4167
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.5640
|
-0.047 10^9 white blood cells per liter
Standard Deviation 0.3703
|
0.061 10^9 white blood cells per liter
Standard Deviation 0.3301
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 16
|
0.052 10^9 white blood cells per liter
Standard Deviation 0.5567
|
0.071 10^9 white blood cells per liter
Standard Deviation 0.3571
|
0.026 10^9 white blood cells per liter
Standard Deviation 0.5539
|
-0.029 10^9 white blood cells per liter
Standard Deviation 0.4991
|
0.135 10^9 white blood cells per liter
Standard Deviation 0.4197
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 20
|
0.003 10^9 white blood cells per liter
Standard Deviation 0.4934
|
0.008 10^9 white blood cells per liter
Standard Deviation 0.3970
|
0.149 10^9 white blood cells per liter
Standard Deviation 0.4675
|
-0.035 10^9 white blood cells per liter
Standard Deviation 0.4566
|
0.126 10^9 white blood cells per liter
Standard Deviation 0.4216
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 28
|
0.036 10^9 white blood cells per liter
Standard Deviation 0.5869
|
0.105 10^9 white blood cells per liter
Standard Deviation 0.3594
|
0.210 10^9 white blood cells per liter
Standard Deviation 0.5999
|
0.103 10^9 white blood cells per liter
Standard Deviation 0.5544
|
0.172 10^9 white blood cells per liter
Standard Deviation 0.3776
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 32
|
-0.000 10^9 white blood cells per liter
Standard Deviation 0.5109
|
0.103 10^9 white blood cells per liter
Standard Deviation 0.4233
|
0.083 10^9 white blood cells per liter
Standard Deviation 0.6524
|
0.112 10^9 white blood cells per liter
Standard Deviation 0.5056
|
0.146 10^9 white blood cells per liter
Standard Deviation 0.3966
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 36
|
0.078 10^9 white blood cells per liter
Standard Deviation 0.4894
|
0.039 10^9 white blood cells per liter
Standard Deviation 0.4227
|
0.134 10^9 white blood cells per liter
Standard Deviation 0.5673
|
0.103 10^9 white blood cells per liter
Standard Deviation 0.5491
|
0.118 10^9 white blood cells per liter
Standard Deviation 0.3810
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 40
|
0.139 10^9 white blood cells per liter
Standard Deviation 0.4871
|
0.168 10^9 white blood cells per liter
Standard Deviation 0.4281
|
0.120 10^9 white blood cells per liter
Standard Deviation 0.6018
|
0.038 10^9 white blood cells per liter
Standard Deviation 0.4335
|
0.176 10^9 white blood cells per liter
Standard Deviation 0.3709
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Lymphocytes Week 48
|
0.066 10^9 white blood cells per liter
Standard Deviation 0.5313
|
0.103 10^9 white blood cells per liter
Standard Deviation 0.3645
|
0.078 10^9 white blood cells per liter
Standard Deviation 0.5041
|
0.019 10^9 white blood cells per liter
Standard Deviation 0.3763
|
0.072 10^9 white blood cells per liter
Standard Deviation 0.3755
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 1
|
0.007 10^9 white blood cells per liter
Standard Deviation 0.2184
|
-0.008 10^9 white blood cells per liter
Standard Deviation 0.1477
|
-0.012 10^9 white blood cells per liter
Standard Deviation 0.1679
|
-0.088 10^9 white blood cells per liter
Standard Deviation 0.2315
|
-0.027 10^9 white blood cells per liter
Standard Deviation 0.1724
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 4
|
0.032 10^9 white blood cells per liter
Standard Deviation 0.1588
|
-0.021 10^9 white blood cells per liter
Standard Deviation 0.1473
|
-0.040 10^9 white blood cells per liter
Standard Deviation 0.1862
|
-0.066 10^9 white blood cells per liter
Standard Deviation 0.2404
|
-0.085 10^9 white blood cells per liter
Standard Deviation 0.1459
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 8
|
0.059 10^9 white blood cells per liter
Standard Deviation 0.1910
|
-0.041 10^9 white blood cells per liter
Standard Deviation 0.1743
|
0.005 10^9 white blood cells per liter
Standard Deviation 0.1580
|
-0.103 10^9 white blood cells per liter
Standard Deviation 0.2520
|
-0.071 10^9 white blood cells per liter
Standard Deviation 0.1834
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 12
|
0.020 10^9 white blood cells per liter
Standard Deviation 0.1913
|
-0.031 10^9 white blood cells per liter
Standard Deviation 0.1608
|
-0.033 10^9 white blood cells per liter
Standard Deviation 0.1686
|
-0.105 10^9 white blood cells per liter
Standard Deviation 0.2630
|
-0.059 10^9 white blood cells per liter
Standard Deviation 0.1414
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 28
|
0.026 10^9 white blood cells per liter
Standard Deviation 0.2087
|
0.042 10^9 white blood cells per liter
Standard Deviation 0.1981
|
0.055 10^9 white blood cells per liter
Standard Deviation 0.1724
|
-0.029 10^9 white blood cells per liter
Standard Deviation 0.2729
|
-0.012 10^9 white blood cells per liter
Standard Deviation 0.1911
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 32
|
0.064 10^9 white blood cells per liter
Standard Deviation 0.2356
|
-0.005 10^9 white blood cells per liter
Standard Deviation 0.1731
|
-0.003 10^9 white blood cells per liter
Standard Deviation 0.1271
|
-0.035 10^9 white blood cells per liter
Standard Deviation 0.2684
|
0.010 10^9 white blood cells per liter
Standard Deviation 0.1744
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 36
|
0.054 10^9 white blood cells per liter
Standard Deviation 0.1626
|
-0.024 10^9 white blood cells per liter
Standard Deviation 0.1792
|
0.032 10^9 white blood cells per liter
Standard Deviation 0.1404
|
-0.036 10^9 white blood cells per liter
Standard Deviation 0.2644
|
0.049 10^9 white blood cells per liter
Standard Deviation 0.2327
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 40
|
0.053 10^9 white blood cells per liter
Standard Deviation 0.1647
|
0.008 10^9 white blood cells per liter
Standard Deviation 0.1323
|
0.020 10^9 white blood cells per liter
Standard Deviation 0.1636
|
-0.059 10^9 white blood cells per liter
Standard Deviation 0.2830
|
-0.018 10^9 white blood cells per liter
Standard Deviation 0.1504
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 44
|
0.019 10^9 white blood cells per liter
Standard Deviation 0.1939
|
-0.008 10^9 white blood cells per liter
Standard Deviation 0.1588
|
0.044 10^9 white blood cells per liter
Standard Deviation 0.1644
|
-0.032 10^9 white blood cells per liter
Standard Deviation 0.2446
|
-0.019 10^9 white blood cells per liter
Standard Deviation 0.2202
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Monocytes Week 48
|
0.021 10^9 white blood cells per liter
Standard Deviation 0.2145
|
0.000 10^9 white blood cells per liter
Standard Deviation 0.1707
|
-0.013 10^9 white blood cells per liter
Standard Deviation 0.1399
|
-0.078 10^9 white blood cells per liter
Standard Deviation 0.2511
|
-0.077 10^9 white blood cells per liter
Standard Deviation 0.1709
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 1
|
-0.200 10^9 white blood cells per liter
Standard Deviation 1.0959
|
-0.558 10^9 white blood cells per liter
Standard Deviation 0.9627
|
-0.693 10^9 white blood cells per liter
Standard Deviation 1.2971
|
-0.934 10^9 white blood cells per liter
Standard Deviation 1.4768
|
-0.325 10^9 white blood cells per liter
Standard Deviation 1.5720
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 8
|
0.249 10^9 white blood cells per liter
Standard Deviation 1.5358
|
-0.346 10^9 white blood cells per liter
Standard Deviation 1.2640
|
-0.256 10^9 white blood cells per liter
Standard Deviation 1.3898
|
-1.021 10^9 white blood cells per liter
Standard Deviation 1.7129
|
-0.717 10^9 white blood cells per liter
Standard Deviation 1.4589
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 12
|
0.117 10^9 white blood cells per liter
Standard Deviation 1.5103
|
-0.456 10^9 white blood cells per liter
Standard Deviation 1.1227
|
-0.458 10^9 white blood cells per liter
Standard Deviation 1.6879
|
-0.832 10^9 white blood cells per liter
Standard Deviation 2.2192
|
-0.673 10^9 white blood cells per liter
Standard Deviation 1.3887
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 16
|
-0.490 10^9 white blood cells per liter
Standard Deviation 1.6866
|
-0.879 10^9 white blood cells per liter
Standard Deviation 1.5752
|
-0.617 10^9 white blood cells per liter
Standard Deviation 1.6027
|
-1.203 10^9 white blood cells per liter
Standard Deviation 2.2840
|
-0.448 10^9 white blood cells per liter
Standard Deviation 1.6816
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 20
|
-0.972 10^9 white blood cells per liter
Standard Deviation 1.2085
|
-1.069 10^9 white blood cells per liter
Standard Deviation 1.4219
|
-0.595 10^9 white blood cells per liter
Standard Deviation 1.4319
|
-0.827 10^9 white blood cells per liter
Standard Deviation 2.2663
|
-0.618 10^9 white blood cells per liter
Standard Deviation 1.5716
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 24
|
-1.210 10^9 white blood cells per liter
Standard Deviation 1.4067
|
-0.895 10^9 white blood cells per liter
Standard Deviation 1.6288
|
-0.593 10^9 white blood cells per liter
Standard Deviation 1.5309
|
-1.011 10^9 white blood cells per liter
Standard Deviation 2.2968
|
-0.850 10^9 white blood cells per liter
Standard Deviation 1.6461
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 28
|
-0.774 10^9 white blood cells per liter
Standard Deviation 1.8189
|
-0.484 10^9 white blood cells per liter
Standard Deviation 2.2620
|
-0.555 10^9 white blood cells per liter
Standard Deviation 1.2608
|
-0.949 10^9 white blood cells per liter
Standard Deviation 1.7676
|
-0.568 10^9 white blood cells per liter
Standard Deviation 1.3889
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 32
|
-0.869 10^9 white blood cells per liter
Standard Deviation 1.2796
|
-0.969 10^9 white blood cells per liter
Standard Deviation 1.8241
|
-0.433 10^9 white blood cells per liter
Standard Deviation 1.7889
|
-1.038 10^9 white blood cells per liter
Standard Deviation 2.4800
|
-0.718 10^9 white blood cells per liter
Standard Deviation 1.4299
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 36
|
-0.722 10^9 white blood cells per liter
Standard Deviation 1.6422
|
-0.992 10^9 white blood cells per liter
Standard Deviation 1.6583
|
-0.541 10^9 white blood cells per liter
Standard Deviation 1.5519
|
-1.185 10^9 white blood cells per liter
Standard Deviation 2.1881
|
-0.354 10^9 white blood cells per liter
Standard Deviation 2.1441
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 44
|
-0.978 10^9 white blood cells per liter
Standard Deviation 1.2444
|
-1.086 10^9 white blood cells per liter
Standard Deviation 1.6049
|
-0.717 10^9 white blood cells per liter
Standard Deviation 1.6966
|
-1.109 10^9 white blood cells per liter
Standard Deviation 2.2673
|
-0.983 10^9 white blood cells per liter
Standard Deviation 1.6556
|
|
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Neutrophils Week 48
|
-0.861 10^9 white blood cells per liter
Standard Deviation 1.6858
|
-0.939 10^9 white blood cells per liter
Standard Deviation 1.5670
|
-0.558 10^9 white blood cells per liter
Standard Deviation 1.7944
|
-1.178 10^9 white blood cells per liter
Standard Deviation 2.6503
|
-0.805 10^9 white blood cells per liter
Standard Deviation 1.6631
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 24
|
1.000 g/L
Standard Deviation 10.9232
|
4.132 g/L
Standard Deviation 10.3849
|
-0.625 g/L
Standard Deviation 14.6685
|
4.583 g/L
Standard Deviation 11.3121
|
4.250 g/L
Standard Deviation 13.4064
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 12
|
-7.927 g/L
Standard Deviation 14.6704
|
-3.179 g/L
Standard Deviation 13.4122
|
-3.907 g/L
Standard Deviation 11.5404
|
-2.684 g/L
Standard Deviation 9.4099
|
1.732 g/L
Standard Deviation 13.3959
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 16
|
-6.286 g/L
Standard Deviation 12.3393
|
-3.000 g/L
Standard Deviation 14.5751
|
-5.262 g/L
Standard Deviation 12.1917
|
-1.026 g/L
Standard Deviation 11.6816
|
-0.700 g/L
Standard Deviation 16.1026
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 20
|
-5.050 g/L
Standard Deviation 12.8102
|
0.923 g/L
Standard Deviation 11.8108
|
-1.902 g/L
Standard Deviation 12.8078
|
0.919 g/L
Standard Deviation 8.7349
|
0.200 g/L
Standard Deviation 16.1725
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 32
|
6.308 g/L
Standard Deviation 9.7796
|
10.231 g/L
Standard Deviation 9.5957
|
4.850 g/L
Standard Deviation 11.3692
|
7.971 g/L
Standard Deviation 12.3497
|
10.462 g/L
Standard Deviation 12.9855
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 40
|
3.108 g/L
Standard Deviation 9.8736
|
8.237 g/L
Standard Deviation 12.0706
|
4.976 g/L
Standard Deviation 11.5639
|
9.088 g/L
Standard Deviation 11.5480
|
9.079 g/L
Standard Deviation 11.5393
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 44
|
6.297 g/L
Standard Deviation 10.6975
|
7.289 g/L
Standard Deviation 12.6254
|
3.415 g/L
Standard Deviation 12.6293
|
6.353 g/L
Standard Deviation 14.3038
|
9.278 g/L
Standard Deviation 12.8076
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 48
|
5.079 g/L
Standard Deviation 10.4916
|
7.216 g/L
Standard Deviation 9.3812
|
2.122 g/L
Standard Deviation 11.8769
|
5.394 g/L
Standard Deviation 12.9300
|
8.250 g/L
Standard Deviation 11.3448
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 1
|
-4.854 g/L
Standard Deviation 5.6726
|
0.000 g/L
Standard Deviation 5.6569
|
1.302 g/L
Standard Deviation 5.1480
|
0.512 g/L
Standard Deviation 6.0462
|
-0.875 g/L
Standard Deviation 4.8368
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 2
|
-4.810 g/L
Standard Deviation 6.5154
|
-0.359 g/L
Standard Deviation 5.2339
|
0.070 g/L
Standard Deviation 6.5915
|
-1.561 g/L
Standard Deviation 6.7047
|
0.317 g/L
Standard Deviation 5.3499
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 12
|
-5.220 g/L
Standard Deviation 6.7879
|
0.692 g/L
Standard Deviation 7.7601
|
2.488 g/L
Standard Deviation 7.6512
|
0.868 g/L
Standard Deviation 7.3344
|
2.488 g/L
Standard Deviation 8.2344
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 16
|
-1.619 g/L
Standard Deviation 6.4768
|
2.579 g/L
Standard Deviation 8.3880
|
1.524 g/L
Standard Deviation 8.7853
|
1.737 g/L
Standard Deviation 7.3547
|
3.125 g/L
Standard Deviation 7.7400
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 32
|
-0.282 g/L
Standard Deviation 8.2684
|
4.487 g/L
Standard Deviation 8.3094
|
4.300 g/L
Standard Deviation 9.4032
|
2.118 g/L
Standard Deviation 7.4254
|
5.615 g/L
Standard Deviation 8.6378
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 36
|
0.947 g/L
Standard Deviation 9.1738
|
6.053 g/L
Standard Deviation 8.1405
|
4.293 g/L
Standard Deviation 9.5766
|
3.818 g/L
Standard Deviation 7.3334
|
4.949 g/L
Standard Deviation 8.4851
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 44
|
1.486 g/L
Standard Deviation 10.1040
|
5.000 g/L
Standard Deviation 9.2998
|
3.659 g/L
Standard Deviation 9.1750
|
4.912 g/L
Standard Deviation 8.5895
|
4.722 g/L
Standard Deviation 8.5511
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 4
|
-3.927 g/L
Standard Deviation 10.0633
|
1.474 g/L
Standard Deviation 10.5849
|
-2.500 g/L
Standard Deviation 11.5045
|
-0.878 g/L
Standard Deviation 9.4026
|
1.756 g/L
Standard Deviation 11.8697
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 8
|
-5.195 g/L
Standard Deviation 11.7158
|
-1.897 g/L
Standard Deviation 11.3249
|
-3.780 g/L
Standard Deviation 10.7576
|
-3.079 g/L
Standard Deviation 10.7033
|
0.610 g/L
Standard Deviation 12.7493
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 28
|
2.179 g/L
Standard Deviation 10.3285
|
4.658 g/L
Standard Deviation 9.6906
|
1.707 g/L
Standard Deviation 9.9505
|
4.400 g/L
Standard Deviation 13.7524
|
6.150 g/L
Standard Deviation 12.5382
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 36
|
5.500 g/L
Standard Deviation 9.7779
|
10.921 g/L
Standard Deviation 10.2229
|
2.732 g/L
Standard Deviation 12.4097
|
6.788 g/L
Standard Deviation 12.2034
|
9.462 g/L
Standard Deviation 12.7998
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 4
|
-4.390 g/L
Standard Deviation 7.5162
|
0.895 g/L
Standard Deviation 7.6434
|
0.881 g/L
Standard Deviation 6.4551
|
0.512 g/L
Standard Deviation 5.7189
|
1.195 g/L
Standard Deviation 5.8916
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 8
|
-4.561 g/L
Standard Deviation 7.0995
|
0.308 g/L
Standard Deviation 7.0865
|
2.195 g/L
Standard Deviation 7.7628
|
0.553 g/L
Standard Deviation 6.8010
|
1.195 g/L
Standard Deviation 7.4439
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 20
|
-0.400 g/L
Standard Deviation 7.3233
|
2.667 g/L
Standard Deviation 8.6764
|
2.268 g/L
Standard Deviation 6.9822
|
1.892 g/L
Standard Deviation 7.6186
|
2.925 g/L
Standard Deviation 7.7207
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 24
|
0.564 g/L
Standard Deviation 8.1879
|
3.658 g/L
Standard Deviation 9.0622
|
4.075 g/L
Standard Deviation 8.0714
|
2.000 g/L
Standard Deviation 6.6462
|
3.425 g/L
Standard Deviation 6.2834
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 28
|
-1.513 g/L
Standard Deviation 8.0259
|
3.342 g/L
Standard Deviation 8.9511
|
3.122 g/L
Standard Deviation 8.6261
|
0.857 g/L
Standard Deviation 7.2645
|
3.400 g/L
Standard Deviation 8.6730
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 40
|
1.432 g/L
Standard Deviation 9.1090
|
5.868 g/L
Standard Deviation 8.7863
|
4.317 g/L
Standard Deviation 9.6552
|
3.618 g/L
Standard Deviation 7.8277
|
4.132 g/L
Standard Deviation 7.7987
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hemoglobin Week 48
|
2.474 g/L
Standard Deviation 9.7002
|
5.270 g/L
Standard Deviation 9.1974
|
3.780 g/L
Standard Deviation 9.9210
|
4.030 g/L
Standard Deviation 9.2550
|
4.725 g/L
Standard Deviation 7.3554
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 1
|
-2.293 g/L
Standard Deviation 8.4594
|
0.789 g/L
Standard Deviation 8.9719
|
-1.860 g/L
Standard Deviation 8.0551
|
0.927 g/L
Standard Deviation 9.1088
|
1.200 g/L
Standard Deviation 12.2395
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Ery. mean corpuscular HGB Week 2
|
-2.310 g/L
Standard Deviation 7.9923
|
2.564 g/L
Standard Deviation 9.8216
|
0.465 g/L
Standard Deviation 8.4778
|
0.707 g/L
Standard Deviation 8.6263
|
2.854 g/L
Standard Deviation 10.1822
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 1
|
-0.073 picograms (pg)
Standard Deviation 0.4980
|
0.058 picograms (pg)
Standard Deviation 0.4624
|
-0.049 picograms (pg)
Standard Deviation 0.4050
|
0.073 picograms (pg)
Standard Deviation 0.3975
|
-0.055 picograms (pg)
Standard Deviation 0.4455
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 24
|
-0.249 picograms (pg)
Standard Deviation 1.0443
|
0.108 picograms (pg)
Standard Deviation 0.9947
|
-0.057 picograms (pg)
Standard Deviation 1.1804
|
-0.097 picograms (pg)
Standard Deviation 0.7284
|
-0.007 picograms (pg)
Standard Deviation 1.2338
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 44
|
0.097 picograms (pg)
Standard Deviation 1.3103
|
0.129 picograms (pg)
Standard Deviation 0.8742
|
-0.080 picograms (pg)
Standard Deviation 1.1771
|
-0.159 picograms (pg)
Standard Deviation 0.7480
|
0.108 picograms (pg)
Standard Deviation 1.2532
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 2
|
-0.050 picograms (pg)
Standard Deviation 0.3890
|
0.126 picograms (pg)
Standard Deviation 0.5149
|
0.023 picograms (pg)
Standard Deviation 0.4225
|
0.066 picograms (pg)
Standard Deviation 0.4357
|
0.085 picograms (pg)
Standard Deviation 0.4287
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 4
|
-0.112 picograms (pg)
Standard Deviation 0.5501
|
0.089 picograms (pg)
Standard Deviation 0.5584
|
0.060 picograms (pg)
Standard Deviation 0.5910
|
0.012 picograms (pg)
Standard Deviation 0.4691
|
0.066 picograms (pg)
Standard Deviation 0.6085
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 8
|
-0.110 picograms (pg)
Standard Deviation 0.6778
|
0.141 picograms (pg)
Standard Deviation 0.6801
|
0.007 picograms (pg)
Standard Deviation 0.5926
|
0.034 picograms (pg)
Standard Deviation 0.6851
|
0.095 picograms (pg)
Standard Deviation 0.7994
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 12
|
-0.285 picograms (pg)
Standard Deviation 0.6770
|
0.023 picograms (pg)
Standard Deviation 0.7253
|
0.091 picograms (pg)
Standard Deviation 0.8358
|
-0.132 picograms (pg)
Standard Deviation 0.8335
|
0.039 picograms (pg)
Standard Deviation 1.0454
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 16
|
-0.233 picograms (pg)
Standard Deviation 0.7281
|
0.097 picograms (pg)
Standard Deviation 0.8824
|
0.014 picograms (pg)
Standard Deviation 0.9236
|
-0.118 picograms (pg)
Standard Deviation 0.8440
|
-0.067 picograms (pg)
Standard Deviation 1.1713
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 20
|
-0.290 picograms (pg)
Standard Deviation 0.8145
|
-0.033 picograms (pg)
Standard Deviation 0.9172
|
0.029 picograms (pg)
Standard Deviation 0.9819
|
-0.035 picograms (pg)
Standard Deviation 0.7013
|
0.075 picograms (pg)
Standard Deviation 1.0824
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 28
|
-0.103 picograms (pg)
Standard Deviation 1.0101
|
0.029 picograms (pg)
Standard Deviation 0.7241
|
-0.122 picograms (pg)
Standard Deviation 1.1130
|
-0.211 picograms (pg)
Standard Deviation 0.8277
|
0.020 picograms (pg)
Standard Deviation 1.2950
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 32
|
0.003 picograms (pg)
Standard Deviation 1.2619
|
0.297 picograms (pg)
Standard Deviation 0.8561
|
0.058 picograms (pg)
Standard Deviation 1.1522
|
0.026 picograms (pg)
Standard Deviation 0.7684
|
0.167 picograms (pg)
Standard Deviation 1.2472
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 36
|
-0.082 picograms (pg)
Standard Deviation 1.3242
|
0.237 picograms (pg)
Standard Deviation 0.8722
|
-0.093 picograms (pg)
Standard Deviation 1.0792
|
-0.248 picograms (pg)
Standard Deviation 0.8581
|
0.118 picograms (pg)
Standard Deviation 1.1473
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 40
|
-0.170 picograms (pg)
Standard Deviation 1.3453
|
0.134 picograms (pg)
Standard Deviation 0.8960
|
-0.134 picograms (pg)
Standard Deviation 1.2095
|
-0.147 picograms (pg)
Standard Deviation 0.8645
|
0.034 picograms (pg)
Standard Deviation 1.0839
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Week 48
|
0.137 picograms (pg)
Standard Deviation 1.4139
|
0.178 picograms (pg)
Standard Deviation 0.9369
|
-0.120 picograms (pg)
Standard Deviation 1.1279
|
-0.030 picograms (pg)
Standard Deviation 0.7888
|
0.140 picograms (pg)
Standard Deviation 1.2161
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 8
|
1.163 femtolitres (fL)
Standard Deviation 3.6524
|
0.938 femtolitres (fL)
Standard Deviation 2.9445
|
1.110 femtolitres (fL)
Standard Deviation 3.0283
|
0.916 femtolitres (fL)
Standard Deviation 3.0058
|
0.090 femtolitres (fL)
Standard Deviation 3.5125
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 12
|
1.478 femtolitres (fL)
Standard Deviation 3.9560
|
0.951 femtolitres (fL)
Standard Deviation 3.4617
|
1.367 femtolitres (fL)
Standard Deviation 3.8471
|
0.342 femtolitres (fL)
Standard Deviation 3.1129
|
-0.390 femtolitres (fL)
Standard Deviation 3.3907
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 24
|
-1.033 femtolitres (fL)
Standard Deviation 2.9007
|
-0.858 femtolitres (fL)
Standard Deviation 2.1793
|
0.143 femtolitres (fL)
Standard Deviation 4.9985
|
-1.522 femtolitres (fL)
Standard Deviation 3.1692
|
-1.195 femtolitres (fL)
Standard Deviation 3.5759
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 28
|
-0.910 femtolitres (fL)
Standard Deviation 2.6477
|
-1.184 femtolitres (fL)
Standard Deviation 2.3264
|
-0.754 femtolitres (fL)
Standard Deviation 3.3662
|
-1.854 femtolitres (fL)
Standard Deviation 3.6605
|
-1.638 femtolitres (fL)
Standard Deviation 3.3447
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 36
|
-1.724 femtolitres (fL)
Standard Deviation 3.1037
|
-2.266 femtolitres (fL)
Standard Deviation 2.3516
|
-0.912 femtolitres (fL)
Standard Deviation 3.9627
|
-2.558 femtolitres (fL)
Standard Deviation 3.8468
|
-2.236 femtolitres (fL)
Standard Deviation 3.2869
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 48
|
-0.942 femtolitres (fL)
Standard Deviation 3.5913
|
-1.492 femtolitres (fL)
Standard Deviation 2.5065
|
-0.846 femtolitres (fL)
Standard Deviation 3.1243
|
-1.527 femtolitres (fL)
Standard Deviation 3.6540
|
-1.788 femtolitres (fL)
Standard Deviation 3.5554
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 1
|
0.422 femtolitres (fL)
Standard Deviation 1.8855
|
-0.087 femtolitres (fL)
Standard Deviation 1.9540
|
0.386 femtolitres (fL)
Standard Deviation 2.2542
|
-0.017 femtolitres (fL)
Standard Deviation 2.1066
|
-0.510 femtolitres (fL)
Standard Deviation 2.7686
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 2
|
0.450 femtolitres (fL)
Standard Deviation 1.8867
|
-0.362 femtolitres (fL)
Standard Deviation 2.1689
|
-0.021 femtolitres (fL)
Standard Deviation 1.8767
|
-0.039 femtolitres (fL)
Standard Deviation 2.3876
|
-0.549 femtolitres (fL)
Standard Deviation 2.5751
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 4
|
0.829 femtolitres (fL)
Standard Deviation 2.3409
|
-0.163 femtolitres (fL)
Standard Deviation 2.4631
|
0.945 femtolitres (fL)
Standard Deviation 3.2325
|
0.354 femtolitres (fL)
Standard Deviation 2.8851
|
-0.259 femtolitres (fL)
Standard Deviation 2.5328
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 16
|
1.107 femtolitres (fL)
Standard Deviation 3.4022
|
1.168 femtolitres (fL)
Standard Deviation 3.7760
|
1.571 femtolitres (fL)
Standard Deviation 4.3326
|
-0.016 femtolitres (fL)
Standard Deviation 3.6944
|
0.048 femtolitres (fL)
Standard Deviation 4.4345
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 20
|
0.497 femtolitres (fL)
Standard Deviation 3.5197
|
-0.349 femtolitres (fL)
Standard Deviation 2.8975
|
0.649 femtolitres (fL)
Standard Deviation 3.7758
|
-0.338 femtolitres (fL)
Standard Deviation 2.5959
|
0.202 femtolitres (fL)
Standard Deviation 4.2993
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 32
|
-1.654 femtolitres (fL)
Standard Deviation 2.7565
|
-1.851 femtolitres (fL)
Standard Deviation 2.4024
|
-1.075 femtolitres (fL)
Standard Deviation 3.5390
|
-2.071 femtolitres (fL)
Standard Deviation 3.7652
|
-2.351 femtolitres (fL)
Standard Deviation 3.1052
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 40
|
-1.386 femtolitres (fL)
Standard Deviation 2.8575
|
-1.882 femtolitres (fL)
Standard Deviation 3.1285
|
-1.698 femtolitres (fL)
Standard Deviation 3.0263
|
-2.885 femtolitres (fL)
Standard Deviation 3.1443
|
-2.421 femtolitres (fL)
Standard Deviation 2.9445
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Week 44
|
-1.405 femtolitres (fL)
Standard Deviation 3.4627
|
-1.632 femtolitres (fL)
Standard Deviation 3.4207
|
-1.117 femtolitres (fL)
Standard Deviation 3.4616
|
-2.171 femtolitres (fL)
Standard Deviation 4.4367
|
-2.186 femtolitres (fL)
Standard Deviation 3.4915
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 1
|
-0.148 10^12 red blood cells per liter
Standard Deviation 0.2071
|
-0.008 10^12 red blood cells per liter
Standard Deviation 0.1927
|
0.050 10^12 red blood cells per liter
Standard Deviation 0.1773
|
0.008 10^12 red blood cells per liter
Standard Deviation 0.2109
|
-0.017 10^12 red blood cells per liter
Standard Deviation 0.1609
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 4
|
-0.132 10^12 red blood cells per liter
Standard Deviation 0.2780
|
0.018 10^12 red blood cells per liter
Standard Deviation 0.2535
|
0.023 10^12 red blood cells per liter
Standard Deviation 0.2135
|
0.013 10^12 red blood cells per liter
Standard Deviation 0.1955
|
0.031 10^12 red blood cells per liter
Standard Deviation 0.2065
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 8
|
-0.135 10^12 red blood cells per liter
Standard Deviation 0.2546
|
-0.011 10^12 red blood cells per liter
Standard Deviation 0.2206
|
0.074 10^12 red blood cells per liter
Standard Deviation 0.2466
|
0.014 10^12 red blood cells per liter
Standard Deviation 0.2190
|
0.026 10^12 red blood cells per liter
Standard Deviation 0.2264
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 12
|
-0.131 10^12 red blood cells per liter
Standard Deviation 0.2678
|
0.021 10^12 red blood cells per liter
Standard Deviation 0.2561
|
0.069 10^12 red blood cells per liter
Standard Deviation 0.2419
|
0.051 10^12 red blood cells per liter
Standard Deviation 0.2243
|
0.075 10^12 red blood cells per liter
Standard Deviation 0.2393
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 16
|
-0.020 10^12 red blood cells per liter
Standard Deviation 0.2375
|
0.075 10^12 red blood cells per liter
Standard Deviation 0.2898
|
0.047 10^12 red blood cells per liter
Standard Deviation 0.2810
|
0.074 10^12 red blood cells per liter
Standard Deviation 0.2255
|
0.110 10^12 red blood cells per liter
Standard Deviation 0.2533
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 32
|
-0.010 10^12 red blood cells per liter
Standard Deviation 0.2461
|
0.104 10^12 red blood cells per liter
Standard Deviation 0.2660
|
0.133 10^12 red blood cells per liter
Standard Deviation 0.2716
|
0.061 10^12 red blood cells per liter
Standard Deviation 0.2555
|
0.156 10^12 red blood cells per liter
Standard Deviation 0.2714
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 36
|
0.044 10^12 red blood cells per liter
Standard Deviation 0.2524
|
0.166 10^12 red blood cells per liter
Standard Deviation 0.2542
|
0.156 10^12 red blood cells per liter
Standard Deviation 0.2849
|
0.161 10^12 red blood cells per liter
Standard Deviation 0.2399
|
0.145 10^12 red blood cells per liter
Standard Deviation 0.2377
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 40
|
0.079 10^12 red blood cells per liter
Standard Deviation 0.2682
|
0.177 10^12 red blood cells per liter
Standard Deviation 0.2733
|
0.163 10^12 red blood cells per liter
Standard Deviation 0.2736
|
0.141 10^12 red blood cells per liter
Standard Deviation 0.2535
|
0.129 10^12 red blood cells per liter
Standard Deviation 0.2403
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 44
|
0.035 10^12 red blood cells per liter
Standard Deviation 0.2645
|
0.146 10^12 red blood cells per liter
Standard Deviation 0.2846
|
0.133 10^12 red blood cells per liter
Standard Deviation 0.2622
|
0.188 10^12 red blood cells per liter
Standard Deviation 0.2933
|
0.135 10^12 red blood cells per liter
Standard Deviation 0.2128
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 48
|
0.061 10^12 red blood cells per liter
Standard Deviation 0.2693
|
0.146 10^12 red blood cells per liter
Standard Deviation 0.2994
|
0.141 10^12 red blood cells per liter
Standard Deviation 0.2747
|
0.135 10^12 red blood cells per liter
Standard Deviation 0.2934
|
0.129 10^12 red blood cells per liter
Standard Deviation 0.2354
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 2
|
-0.149 10^12 red blood cells per liter
Standard Deviation 0.2244
|
-0.029 10^12 red blood cells per liter
Standard Deviation 0.1788
|
-0.004 10^12 red blood cells per liter
Standard Deviation 0.2280
|
-0.063 10^12 red blood cells per liter
Standard Deviation 0.2236
|
0.000 10^12 red blood cells per liter
Standard Deviation 0.1809
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 20
|
0.036 10^12 red blood cells per liter
Standard Deviation 0.2618
|
0.096 10^12 red blood cells per liter
Standard Deviation 0.2855
|
0.068 10^12 red blood cells per liter
Standard Deviation 0.2089
|
0.064 10^12 red blood cells per liter
Standard Deviation 0.2273
|
0.081 10^12 red blood cells per liter
Standard Deviation 0.2191
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 24
|
0.059 10^12 red blood cells per liter
Standard Deviation 0.2639
|
0.110 10^12 red blood cells per liter
Standard Deviation 0.2974
|
0.142 10^12 red blood cells per liter
Standard Deviation 0.2573
|
0.074 10^12 red blood cells per liter
Standard Deviation 0.2250
|
0.110 10^12 red blood cells per liter
Standard Deviation 0.1931
|
|
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Week 28
|
-0.034 10^12 red blood cells per liter
Standard Deviation 0.2453
|
0.108 10^12 red blood cells per liter
Standard Deviation 0.2681
|
0.122 10^12 red blood cells per liter
Standard Deviation 0.2445
|
0.058 10^12 red blood cells per liter
Standard Deviation 0.2359
|
0.106 10^12 red blood cells per liter
Standard Deviation 0.2567
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 1
|
-0.011 volume % of red blood cells
Standard Deviation 0.0189
|
-0.001 volume % of red blood cells
Standard Deviation 0.0211
|
0.007 volume % of red blood cells
Standard Deviation 0.0181
|
0.000 volume % of red blood cells
Standard Deviation 0.0206
|
-0.004 volume % of red blood cells
Standard Deviation 0.0206
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 2
|
-0.011 volume % of red blood cells
Standard Deviation 0.0230
|
-0.004 volume % of red blood cells
Standard Deviation 0.0204
|
-0.000 volume % of red blood cells
Standard Deviation 0.0205
|
-0.006 volume % of red blood cells
Standard Deviation 0.0220
|
-0.003 volume % of red blood cells
Standard Deviation 0.0174
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 12
|
-0.005 volume % of red blood cells
Standard Deviation 0.0287
|
0.007 volume % of red blood cells
Standard Deviation 0.0281
|
0.013 volume % of red blood cells
Standard Deviation 0.0276
|
0.006 volume % of red blood cells
Standard Deviation 0.0219
|
0.005 volume % of red blood cells
Standard Deviation 0.0231
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 28
|
-0.007 volume % of red blood cells
Standard Deviation 0.0210
|
0.004 volume % of red blood cells
Standard Deviation 0.0248
|
0.008 volume % of red blood cells
Standard Deviation 0.0241
|
-0.003 volume % of red blood cells
Standard Deviation 0.0229
|
0.002 volume % of red blood cells
Standard Deviation 0.0238
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 32
|
-0.009 volume % of red blood cells
Standard Deviation 0.0207
|
0.000 volume % of red blood cells
Standard Deviation 0.0249
|
0.007 volume % of red blood cells
Standard Deviation 0.0225
|
-0.004 volume % of red blood cells
Standard Deviation 0.0196
|
0.003 volume % of red blood cells
Standard Deviation 0.0248
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 36
|
-0.004 volume % of red blood cells
Standard Deviation 0.0222
|
0.004 volume % of red blood cells
Standard Deviation 0.0228
|
0.009 volume % of red blood cells
Standard Deviation 0.0258
|
0.003 volume % of red blood cells
Standard Deviation 0.0221
|
0.003 volume % of red blood cells
Standard Deviation 0.0234
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 4
|
-0.008 volume % of red blood cells
Standard Deviation 0.0254
|
0.001 volume % of red blood cells
Standard Deviation 0.0211
|
0.006 volume % of red blood cells
Standard Deviation 0.0220
|
0.003 volume % of red blood cells
Standard Deviation 0.0190
|
0.001 volume % of red blood cells
Standard Deviation 0.0209
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 8
|
-0.007 volume % of red blood cells
Standard Deviation 0.0239
|
0.003 volume % of red blood cells
Standard Deviation 0.0244
|
0.012 volume % of red blood cells
Standard Deviation 0.0237
|
0.005 volume % of red blood cells
Standard Deviation 0.0208
|
0.003 volume % of red blood cells
Standard Deviation 0.0232
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 16
|
0.004 volume % of red blood cells
Standard Deviation 0.0202
|
0.012 volume % of red blood cells
Standard Deviation 0.0259
|
0.011 volume % of red blood cells
Standard Deviation 0.0254
|
0.006 volume % of red blood cells
Standard Deviation 0.0240
|
0.010 volume % of red blood cells
Standard Deviation 0.0252
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 20
|
0.006 volume % of red blood cells
Standard Deviation 0.0217
|
0.007 volume % of red blood cells
Standard Deviation 0.0270
|
0.010 volume % of red blood cells
Standard Deviation 0.0211
|
0.004 volume % of red blood cells
Standard Deviation 0.0241
|
0.008 volume % of red blood cells
Standard Deviation 0.0246
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 24
|
0.001 volume % of red blood cells
Standard Deviation 0.0192
|
0.006 volume % of red blood cells
Standard Deviation 0.0253
|
0.014 volume % of red blood cells
Standard Deviation 0.0256
|
-0.000 volume % of red blood cells
Standard Deviation 0.0222
|
0.005 volume % of red blood cells
Standard Deviation 0.0219
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 40
|
0.000 volume % of red blood cells
Standard Deviation 0.0231
|
0.007 volume % of red blood cells
Standard Deviation 0.0278
|
0.007 volume % of red blood cells
Standard Deviation 0.0246
|
-0.001 volume % of red blood cells
Standard Deviation 0.0221
|
0.000 volume % of red blood cells
Standard Deviation 0.0206
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 44
|
-0.003 volume % of red blood cells
Standard Deviation 0.0272
|
0.006 volume % of red blood cells
Standard Deviation 0.0297
|
0.007 volume % of red blood cells
Standard Deviation 0.0239
|
0.007 volume % of red blood cells
Standard Deviation 0.0246
|
0.002 volume % of red blood cells
Standard Deviation 0.0194
|
|
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Week 48
|
0.001 volume % of red blood cells
Standard Deviation 0.0243
|
0.007 volume % of red blood cells
Standard Deviation 0.0257
|
0.009 volume % of red blood cells
Standard Deviation 0.0260
|
0.005 volume % of red blood cells
Standard Deviation 0.0252
|
0.004 volume % of red blood cells
Standard Deviation 0.0212
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Platelets was measured in number of platelets per liter (10\^9/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 1
|
-5.073 10^9 platelets per liter
Standard Deviation 30.2609
|
-3.368 10^9 platelets per liter
Standard Deviation 25.9515
|
3.209 10^9 platelets per liter
Standard Deviation 30.5883
|
-2.098 10^9 platelets per liter
Standard Deviation 24.6412
|
-9.325 10^9 platelets per liter
Standard Deviation 23.4109
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 2
|
4.000 10^9 platelets per liter
Standard Deviation 27.3112
|
-5.179 10^9 platelets per liter
Standard Deviation 38.2800
|
-3.810 10^9 platelets per liter
Standard Deviation 41.8250
|
-15.122 10^9 platelets per liter
Standard Deviation 32.8414
|
-15.415 10^9 platelets per liter
Standard Deviation 31.7025
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 4
|
-3.927 10^9 platelets per liter
Standard Deviation 29.6643
|
-6.868 10^9 platelets per liter
Standard Deviation 29.7487
|
-13.878 10^9 platelets per liter
Standard Deviation 43.7568
|
-19.415 10^9 platelets per liter
Standard Deviation 32.6450
|
-27.073 10^9 platelets per liter
Standard Deviation 41.9299
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 8
|
1.561 10^9 platelets per liter
Standard Deviation 29.1042
|
-12.077 10^9 platelets per liter
Standard Deviation 28.9876
|
-5.475 10^9 platelets per liter
Standard Deviation 44.7718
|
-17.605 10^9 platelets per liter
Standard Deviation 29.8442
|
-26.195 10^9 platelets per liter
Standard Deviation 44.1719
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 12
|
-2.171 10^9 platelets per liter
Standard Deviation 32.0795
|
-17.359 10^9 platelets per liter
Standard Deviation 35.4308
|
-11.286 10^9 platelets per liter
Standard Deviation 40.7451
|
-10.079 10^9 platelets per liter
Standard Deviation 44.8977
|
-23.171 10^9 platelets per liter
Standard Deviation 47.2995
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 16
|
-18.833 10^9 platelets per liter
Standard Deviation 50.4844
|
-18.263 10^9 platelets per liter
Standard Deviation 37.3259
|
-13.952 10^9 platelets per liter
Standard Deviation 50.7173
|
-9.895 10^9 platelets per liter
Standard Deviation 35.3246
|
-25.425 10^9 platelets per liter
Standard Deviation 37.6556
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 20
|
-18.625 10^9 platelets per liter
Standard Deviation 50.3988
|
-23.077 10^9 platelets per liter
Standard Deviation 39.6534
|
-10.512 10^9 platelets per liter
Standard Deviation 48.0755
|
-15.324 10^9 platelets per liter
Standard Deviation 28.8329
|
-22.725 10^9 platelets per liter
Standard Deviation 42.2502
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 24
|
-19.974 10^9 platelets per liter
Standard Deviation 49.0196
|
-14.000 10^9 platelets per liter
Standard Deviation 37.7760
|
-4.600 10^9 platelets per liter
Standard Deviation 49.4025
|
-10.972 10^9 platelets per liter
Standard Deviation 36.8375
|
-22.900 10^9 platelets per liter
Standard Deviation 47.4092
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 28
|
-24.256 10^9 platelets per liter
Standard Deviation 51.8001
|
-16.868 10^9 platelets per liter
Standard Deviation 40.6635
|
-7.683 10^9 platelets per liter
Standard Deviation 47.8155
|
-12.800 10^9 platelets per liter
Standard Deviation 30.7904
|
-19.600 10^9 platelets per liter
Standard Deviation 42.3052
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 32
|
-22.410 10^9 platelets per liter
Standard Deviation 51.9553
|
-18.590 10^9 platelets per liter
Standard Deviation 41.7226
|
-13.575 10^9 platelets per liter
Standard Deviation 51.9304
|
-20.618 10^9 platelets per liter
Standard Deviation 38.8969
|
-23.179 10^9 platelets per liter
Standard Deviation 42.2018
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 36
|
-25.000 10^9 platelets per liter
Standard Deviation 52.6990
|
-16.474 10^9 platelets per liter
Standard Deviation 46.8844
|
-14.561 10^9 platelets per liter
Standard Deviation 50.2106
|
-18.848 10^9 platelets per liter
Standard Deviation 40.0563
|
-23.846 10^9 platelets per liter
Standard Deviation 45.1340
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 40
|
-23.432 10^9 platelets per liter
Standard Deviation 53.2747
|
-20.895 10^9 platelets per liter
Standard Deviation 41.4845
|
-14.927 10^9 platelets per liter
Standard Deviation 51.2652
|
-24.088 10^9 platelets per liter
Standard Deviation 33.4133
|
-21.789 10^9 platelets per liter
Standard Deviation 46.1467
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 44
|
-22.703 10^9 platelets per liter
Standard Deviation 57.8383
|
-22.474 10^9 platelets per liter
Standard Deviation 41.0627
|
-18.051 10^9 platelets per liter
Standard Deviation 49.1646
|
-24.735 10^9 platelets per liter
Standard Deviation 38.4710
|
-31.389 10^9 platelets per liter
Standard Deviation 48.5306
|
|
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Week 48
|
-27.395 10^9 platelets per liter
Standard Deviation 56.2963
|
-23.811 10^9 platelets per liter
Standard Deviation 47.1150
|
-24.220 10^9 platelets per liter
Standard Deviation 46.2458
|
-22.273 10^9 platelets per liter
Standard Deviation 37.4243
|
-28.974 10^9 platelets per liter
Standard Deviation 42.9960
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 2
|
-1.714 U/L
Standard Deviation 15.4624
|
2.026 U/L
Standard Deviation 8.9428
|
-1.047 U/L
Standard Deviation 41.1223
|
4.927 U/L
Standard Deviation 20.9623
|
1.171 U/L
Standard Deviation 10.2978
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 8
|
-4.707 U/L
Standard Deviation 13.6478
|
-1.385 U/L
Standard Deviation 9.4580
|
5.465 U/L
Standard Deviation 68.0764
|
0.795 U/L
Standard Deviation 11.4321
|
-1.659 U/L
Standard Deviation 11.1009
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 16
|
-2.048 U/L
Standard Deviation 18.0026
|
2.684 U/L
Standard Deviation 16.3229
|
-4.857 U/L
Standard Deviation 38.6211
|
0.579 U/L
Standard Deviation 12.9273
|
0.829 U/L
Standard Deviation 11.5432
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 20
|
0.300 U/L
Standard Deviation 39.9482
|
3.821 U/L
Standard Deviation 13.0139
|
-4.881 U/L
Standard Deviation 39.1808
|
-0.838 U/L
Standard Deviation 11.1118
|
-1.350 U/L
Standard Deviation 10.5479
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 1
|
-1.098 U/L
Standard Deviation 6.0034
|
-1.342 U/L
Standard Deviation 8.0983
|
-2.721 U/L
Standard Deviation 7.2056
|
-3.244 U/L
Standard Deviation 4.9989
|
-4.275 U/L
Standard Deviation 7.1360
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 4
|
-1.634 U/L
Standard Deviation 9.0630
|
-1.077 U/L
Standard Deviation 10.4236
|
-3.262 U/L
Standard Deviation 9.9144
|
-1.439 U/L
Standard Deviation 18.3508
|
-4.829 U/L
Standard Deviation 10.9268
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 8
|
-2.220 U/L
Standard Deviation 8.3711
|
0.308 U/L
Standard Deviation 12.6515
|
1.233 U/L
Standard Deviation 37.8014
|
-5.026 U/L
Standard Deviation 10.2019
|
-3.585 U/L
Standard Deviation 9.8336
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 12
|
-2.463 U/L
Standard Deviation 8.8122
|
-0.462 U/L
Standard Deviation 12.1066
|
-5.952 U/L
Standard Deviation 11.0695
|
-4.947 U/L
Standard Deviation 12.0538
|
-3.146 U/L
Standard Deviation 17.2476
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 16
|
-8.357 U/L
Standard Deviation 12.7276
|
-0.895 U/L
Standard Deviation 13.1515
|
-7.238 U/L
Standard Deviation 10.7722
|
-4.605 U/L
Standard Deviation 11.6539
|
-1.512 U/L
Standard Deviation 25.7722
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 36
|
-11.816 U/L
Standard Deviation 19.2436
|
-6.368 U/L
Standard Deviation 15.4735
|
-11.122 U/L
Standard Deviation 12.3495
|
-8.059 U/L
Standard Deviation 9.5217
|
-6.487 U/L
Standard Deviation 19.2434
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 48
|
-12.211 U/L
Standard Deviation 19.0379
|
-6.500 U/L
Standard Deviation 16.5313
|
-11.049 U/L
Standard Deviation 14.4827
|
-7.765 U/L
Standard Deviation 12.3290
|
-7.875 U/L
Standard Deviation 20.1370
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 1
|
-2.854 U/L
Standard Deviation 10.3212
|
1.447 U/L
Standard Deviation 6.2155
|
-0.023 U/L
Standard Deviation 27.5409
|
2.244 U/L
Standard Deviation 6.7889
|
0.475 U/L
Standard Deviation 5.2963
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 4
|
-3.976 U/L
Standard Deviation 10.6642
|
1.289 U/L
Standard Deviation 7.5584
|
-3.262 U/L
Standard Deviation 25.1047
|
8.927 U/L
Standard Deviation 52.0660
|
-1.195 U/L
Standard Deviation 4.2791
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 8
|
-1.829 U/L
Standard Deviation 5.9745
|
-4.410 U/L
Standard Deviation 11.6319
|
11.581 U/L
Standard Deviation 103.8974
|
-1.795 U/L
Standard Deviation 5.7454
|
-1.805 U/L
Standard Deviation 9.0698
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 12
|
-0.927 U/L
Standard Deviation 28.3058
|
4.077 U/L
Standard Deviation 21.0905
|
2.119 U/L
Standard Deviation 27.5134
|
3.342 U/L
Standard Deviation 17.0346
|
1.049 U/L
Standard Deviation 22.9303
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 24
|
-1.564 U/L
Standard Deviation 19.4974
|
2.789 U/L
Standard Deviation 14.5475
|
-5.659 U/L
Standard Deviation 39.6652
|
1.528 U/L
Standard Deviation 11.0259
|
-3.475 U/L
Standard Deviation 8.6202
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 28
|
-3.385 U/L
Standard Deviation 17.7373
|
2.658 U/L
Standard Deviation 12.8174
|
-3.244 U/L
Standard Deviation 43.4688
|
-0.171 U/L
Standard Deviation 8.7228
|
-2.775 U/L
Standard Deviation 10.4280
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 32
|
-4.487 U/L
Standard Deviation 16.5400
|
2.385 U/L
Standard Deviation 12.8956
|
-4.150 U/L
Standard Deviation 44.0126
|
-2.176 U/L
Standard Deviation 12.7742
|
-0.821 U/L
Standard Deviation 11.5482
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 36
|
0.579 U/L
Standard Deviation 10.5411
|
0.184 U/L
Standard Deviation 11.8660
|
-2.976 U/L
Standard Deviation 42.9275
|
-0.471 U/L
Standard Deviation 11.2848
|
-1.103 U/L
Standard Deviation 10.6296
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 40
|
-0.622 U/L
Standard Deviation 10.2506
|
0.816 U/L
Standard Deviation 12.6680
|
-2.780 U/L
Standard Deviation 44.9719
|
-3.853 U/L
Standard Deviation 11.1059
|
-1.385 U/L
Standard Deviation 13.1061
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 44
|
2.649 U/L
Standard Deviation 19.7993
|
1.474 U/L
Standard Deviation 13.1514
|
-3.415 U/L
Standard Deviation 43.2966
|
-3.882 U/L
Standard Deviation 12.8741
|
-2.692 U/L
Standard Deviation 10.2525
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 48
|
2.605 U/L
Standard Deviation 14.0646
|
2.216 U/L
Standard Deviation 12.8542
|
-4.561 U/L
Standard Deviation 43.1926
|
-3.794 U/L
Standard Deviation 13.1628
|
-0.575 U/L
Standard Deviation 9.6181
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 2
|
-1.905 U/L
Standard Deviation 6.7960
|
-3.282 U/L
Standard Deviation 7.8370
|
-4.349 U/L
Standard Deviation 9.5963
|
-4.805 U/L
Standard Deviation 7.8237
|
-3.585 U/L
Standard Deviation 8.8430
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 20
|
-10.425 U/L
Standard Deviation 14.0510
|
-5.410 U/L
Standard Deviation 15.1895
|
-10.143 U/L
Standard Deviation 13.0264
|
-7.027 U/L
Standard Deviation 11.8544
|
-6.650 U/L
Standard Deviation 14.8143
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 24
|
-12.795 U/L
Standard Deviation 15.4752
|
-4.769 U/L
Standard Deviation 13.8097
|
-9.463 U/L
Standard Deviation 11.3448
|
-6.361 U/L
Standard Deviation 12.7843
|
-7.225 U/L
Standard Deviation 18.4231
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 28
|
-12.795 U/L
Standard Deviation 16.9351
|
-5.684 U/L
Standard Deviation 15.7259
|
-11.244 U/L
Standard Deviation 12.6249
|
-8.314 U/L
Standard Deviation 10.9054
|
-8.525 U/L
Standard Deviation 16.8523
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 32
|
-13.667 U/L
Standard Deviation 16.1870
|
-4.769 U/L
Standard Deviation 16.1530
|
-10.900 U/L
Standard Deviation 13.0026
|
-9.118 U/L
Standard Deviation 12.5765
|
-8.385 U/L
Standard Deviation 17.5988
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 40
|
-11.000 U/L
Standard Deviation 16.9706
|
-5.658 U/L
Standard Deviation 15.7485
|
-11.024 U/L
Standard Deviation 12.9180
|
-10.559 U/L
Standard Deviation 11.6987
|
-8.175 U/L
Standard Deviation 17.8884
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alkaline Phosphatase Week 44
|
-12.622 U/L
Standard Deviation 17.6373
|
-6.421 U/L
Standard Deviation 14.9099
|
-10.537 U/L
Standard Deviation 13.5759
|
-8.647 U/L
Standard Deviation 10.5483
|
-8.950 U/L
Standard Deviation 18.3162
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 2
|
-1.762 U/L
Standard Deviation 10.5294
|
0.487 U/L
Standard Deviation 4.0967
|
-2.233 U/L
Standard Deviation 26.3266
|
3.805 U/L
Standard Deviation 14.7635
|
0.780 U/L
Standard Deviation 6.1746
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 8
|
-3.537 U/L
Standard Deviation 10.5477
|
-0.077 U/L
Standard Deviation 5.8687
|
2.279 U/L
Standard Deviation 34.7805
|
1.410 U/L
Standard Deviation 5.5900
|
0.366 U/L
Standard Deviation 6.1877
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 12
|
-3.049 U/L
Standard Deviation 12.2106
|
0.436 U/L
Standard Deviation 5.3054
|
-2.595 U/L
Standard Deviation 22.5324
|
1.053 U/L
Standard Deviation 6.9006
|
1.122 U/L
Standard Deviation 6.2897
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 16
|
-1.048 U/L
Standard Deviation 12.1313
|
2.974 U/L
Standard Deviation 8.3649
|
-2.595 U/L
Standard Deviation 24.3852
|
1.526 U/L
Standard Deviation 6.6688
|
2.122 U/L
Standard Deviation 6.1733
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 20
|
6.375 U/L
Standard Deviation 60.1309
|
2.821 U/L
Standard Deviation 6.6367
|
-1.095 U/L
Standard Deviation 25.1317
|
1.324 U/L
Standard Deviation 7.1065
|
0.500 U/L
Standard Deviation 4.8569
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 24
|
1.718 U/L
Standard Deviation 23.7940
|
2.237 U/L
Standard Deviation 6.9182
|
-1.902 U/L
Standard Deviation 26.1054
|
2.889 U/L
Standard Deviation 6.2554
|
0.325 U/L
Standard Deviation 4.3759
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 28
|
-1.179 U/L
Standard Deviation 13.4905
|
2.289 U/L
Standard Deviation 6.9512
|
-1.805 U/L
Standard Deviation 27.4583
|
2.229 U/L
Standard Deviation 6.3063
|
0.175 U/L
Standard Deviation 4.1255
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 32
|
-1.385 U/L
Standard Deviation 12.2895
|
1.949 U/L
Standard Deviation 6.2826
|
-0.575 U/L
Standard Deviation 28.3177
|
0.324 U/L
Standard Deviation 6.2654
|
2.051 U/L
Standard Deviation 4.9997
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 36
|
0.711 U/L
Standard Deviation 7.3113
|
1.026 U/L
Standard Deviation 5.5140
|
-1.220 U/L
Standard Deviation 25.5798
|
1.588 U/L
Standard Deviation 6.6017
|
1.667 U/L
Standard Deviation 6.0755
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 40
|
0.946 U/L
Standard Deviation 12.1494
|
1.316 U/L
Standard Deviation 5.5269
|
0.244 U/L
Standard Deviation 29.2701
|
-0.647 U/L
Standard Deviation 6.0597
|
2.462 U/L
Standard Deviation 8.4972
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 44
|
2.838 U/L
Standard Deviation 15.4641
|
2.553 U/L
Standard Deviation 7.9175
|
-1.268 U/L
Standard Deviation 28.4280
|
-0.588 U/L
Standard Deviation 7.7190
|
1.590 U/L
Standard Deviation 6.9347
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Aspartate Aminotransferase Week 48
|
2.158 U/L
Standard Deviation 9.7939
|
3.459 U/L
Standard Deviation 6.3403
|
-1.927 U/L
Standard Deviation 28.3182
|
0.441 U/L
Standard Deviation 6.6796
|
2.900 U/L
Standard Deviation 6.2339
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 1
|
0.171 U/L
Standard Deviation 5.4447
|
-2.737 U/L
Standard Deviation 7.0354
|
-0.535 U/L
Standard Deviation 10.8745
|
0.171 U/L
Standard Deviation 5.0245
|
-2.300 U/L
Standard Deviation 6.2684
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 2
|
-0.190 U/L
Standard Deviation 5.8736
|
-2.026 U/L
Standard Deviation 7.6828
|
-4.116 U/L
Standard Deviation 25.7527
|
-0.341 U/L
Standard Deviation 5.2517
|
-1.268 U/L
Standard Deviation 7.8773
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 4
|
-0.220 U/L
Standard Deviation 7.2129
|
-2.641 U/L
Standard Deviation 9.9167
|
-6.143 U/L
Standard Deviation 35.5504
|
1.171 U/L
Standard Deviation 17.6265
|
0.512 U/L
Standard Deviation 16.3968
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 12
|
-0.585 U/L
Standard Deviation 5.9033
|
-2.154 U/L
Standard Deviation 10.7643
|
-5.762 U/L
Standard Deviation 34.8767
|
-0.447 U/L
Standard Deviation 8.3785
|
3.244 U/L
Standard Deviation 21.8229
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 16
|
-0.357 U/L
Standard Deviation 9.6445
|
-1.842 U/L
Standard Deviation 13.4476
|
-4.357 U/L
Standard Deviation 34.0020
|
-0.947 U/L
Standard Deviation 8.1868
|
15.024 U/L
Standard Deviation 77.1617
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 20
|
-0.750 U/L
Standard Deviation 9.5051
|
-2.769 U/L
Standard Deviation 13.0555
|
-5.452 U/L
Standard Deviation 32.1970
|
-1.649 U/L
Standard Deviation 5.5137
|
1.475 U/L
Standard Deviation 22.2722
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 24
|
-0.615 U/L
Standard Deviation 12.4173
|
-2.769 U/L
Standard Deviation 10.9339
|
-4.122 U/L
Standard Deviation 36.6832
|
-2.639 U/L
Standard Deviation 9.4360
|
-2.625 U/L
Standard Deviation 10.3272
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 28
|
-0.462 U/L
Standard Deviation 11.5618
|
-2.132 U/L
Standard Deviation 11.7638
|
-6.341 U/L
Standard Deviation 36.7434
|
-2.629 U/L
Standard Deviation 7.6354
|
-0.200 U/L
Standard Deviation 11.5585
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 32
|
0.359 U/L
Standard Deviation 15.7872
|
-1.538 U/L
Standard Deviation 13.2463
|
-7.875 U/L
Standard Deviation 36.9103
|
-3.676 U/L
Standard Deviation 8.6435
|
2.795 U/L
Standard Deviation 21.1501
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 36
|
-0.026 U/L
Standard Deviation 14.7162
|
-4.289 U/L
Standard Deviation 11.4559
|
-8.195 U/L
Standard Deviation 38.6899
|
-2.735 U/L
Standard Deviation 7.1236
|
1.410 U/L
Standard Deviation 18.0200
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 40
|
-2.568 U/L
Standard Deviation 9.3676
|
-3.842 U/L
Standard Deviation 13.9275
|
-9.073 U/L
Standard Deviation 40.5792
|
-4.088 U/L
Standard Deviation 7.5573
|
0.925 U/L
Standard Deviation 20.1066
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 44
|
1.081 U/L
Standard Deviation 23.2108
|
-1.289 U/L
Standard Deviation 21.3730
|
-7.488 U/L
Standard Deviation 34.4145
|
-3.824 U/L
Standard Deviation 7.0430
|
-0.949 U/L
Standard Deviation 11.5643
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Gamma Glutamyl Transferase Week 48
|
1.474 U/L
Standard Deviation 17.6723
|
-2.184 U/L
Standard Deviation 12.0850
|
-7.805 U/L
Standard Deviation 35.4924
|
-2.941 U/L
Standard Deviation 8.8247
|
2.525 U/L
Standard Deviation 20.6112
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 1
|
-7.000 U/L
Standard Deviation 16.1509
|
0.026 U/L
Standard Deviation 19.6118
|
-1.163 U/L
Standard Deviation 33.1669
|
-0.585 U/L
Standard Deviation 16.6673
|
-1.075 U/L
Standard Deviation 18.4341
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 2
|
-5.929 U/L
Standard Deviation 18.4858
|
-0.410 U/L
Standard Deviation 14.9045
|
-5.930 U/L
Standard Deviation 32.8325
|
-2.439 U/L
Standard Deviation 19.2146
|
0.537 U/L
Standard Deviation 19.7270
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 4
|
-5.634 U/L
Standard Deviation 25.5693
|
4.846 U/L
Standard Deviation 21.4372
|
-6.190 U/L
Standard Deviation 29.5265
|
0.854 U/L
Standard Deviation 26.6238
|
-4.293 U/L
Standard Deviation 17.4732
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 8
|
-3.561 U/L
Standard Deviation 17.3249
|
0.026 U/L
Standard Deviation 19.0449
|
0.140 U/L
Standard Deviation 38.8413
|
3.513 U/L
Standard Deviation 18.6503
|
1.439 U/L
Standard Deviation 24.0230
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 16
|
0.881 U/L
Standard Deviation 26.0180
|
15.447 U/L
Standard Deviation 62.0267
|
-4.381 U/L
Standard Deviation 35.9600
|
0.474 U/L
Standard Deviation 19.8967
|
1.488 U/L
Standard Deviation 21.8325
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 20
|
1.200 U/L
Standard Deviation 35.1817
|
2.154 U/L
Standard Deviation 22.8825
|
2.500 U/L
Standard Deviation 31.6145
|
0.676 U/L
Standard Deviation 20.9206
|
2.025 U/L
Standard Deviation 23.0401
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 24
|
4.462 U/L
Standard Deviation 31.9282
|
1.333 U/L
Standard Deviation 22.1862
|
2.878 U/L
Standard Deviation 44.9662
|
1.944 U/L
Standard Deviation 23.5638
|
8.550 U/L
Standard Deviation 25.3093
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 28
|
1.436 U/L
Standard Deviation 21.1122
|
-4.763 U/L
Standard Deviation 21.2138
|
-2.902 U/L
Standard Deviation 34.3590
|
8.143 U/L
Standard Deviation 44.0929
|
1.250 U/L
Standard Deviation 22.0962
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 32
|
-6.333 U/L
Standard Deviation 23.0587
|
-6.410 U/L
Standard Deviation 23.8324
|
-4.525 U/L
Standard Deviation 35.2762
|
-2.971 U/L
Standard Deviation 27.9171
|
-1.615 U/L
Standard Deviation 24.8052
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 36
|
0.553 U/L
Standard Deviation 37.3889
|
-4.658 U/L
Standard Deviation 16.8383
|
-7.585 U/L
Standard Deviation 35.0442
|
-6.147 U/L
Standard Deviation 21.6895
|
5.436 U/L
Standard Deviation 30.0436
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 40
|
-0.216 U/L
Standard Deviation 34.5214
|
-8.289 U/L
Standard Deviation 17.4896
|
-6.366 U/L
Standard Deviation 36.6898
|
-10.618 U/L
Standard Deviation 24.4293
|
0.000 U/L
Standard Deviation 29.3852
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 44
|
-0.757 U/L
Standard Deviation 32.2847
|
-5.316 U/L
Standard Deviation 21.4805
|
-5.000 U/L
Standard Deviation 34.6259
|
-5.059 U/L
Standard Deviation 22.2683
|
1.675 U/L
Standard Deviation 24.9588
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Lactate Dehydrogenase Week 48
|
4.447 U/L
Standard Deviation 34.3493
|
-1.395 U/L
Standard Deviation 23.8061
|
-4.707 U/L
Standard Deviation 38.6654
|
-7.441 U/L
Standard Deviation 23.0443
|
4.500 U/L
Standard Deviation 37.8120
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 1
|
-1.366 U/L
Standard Deviation 12.7451
|
2.526 U/L
Standard Deviation 15.5211
|
2.628 U/L
Standard Deviation 42.1234
|
3.122 U/L
Standard Deviation 10.2791
|
0.700 U/L
Standard Deviation 9.5868
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 4
|
-3.854 U/L
Standard Deviation 15.1897
|
1.553 U/L
Standard Deviation 16.2758
|
-3.952 U/L
Standard Deviation 38.9546
|
22.756 U/L
Standard Deviation 139.8531
|
-1.561 U/L
Standard Deviation 10.1392
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine Aminotransferase Week 12
|
-4.220 U/L
Standard Deviation 15.1765
|
0.359 U/L
Standard Deviation 12.2356
|
-4.429 U/L
Standard Deviation 38.1756
|
1.184 U/L
Standard Deviation 13.0692
|
-1.390 U/L
Standard Deviation 8.1941
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Albumin was measured in grams per liter (g/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 24
|
0.385 g/L
Standard Deviation 1.7262
|
0.949 g/L
Standard Deviation 2.3164
|
1.341 g/L
Standard Deviation 1.8790
|
0.722 g/L
Standard Deviation 2.2502
|
0.875 g/L
Standard Deviation 2.3004
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 1
|
-1.000 g/L
Standard Deviation 1.7464
|
-0.079 g/L
Standard Deviation 2.1357
|
0.279 g/L
Standard Deviation 1.8038
|
-0.439 g/L
Standard Deviation 1.8715
|
-0.350 g/L
Standard Deviation 1.6259
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 2
|
-0.500 g/L
Standard Deviation 2.0982
|
0.051 g/L
Standard Deviation 1.5719
|
0.419 g/L
Standard Deviation 1.9908
|
-0.537 g/L
Standard Deviation 2.0988
|
-0.073 g/L
Standard Deviation 1.8220
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 4
|
-0.683 g/L
Standard Deviation 2.4743
|
0.538 g/L
Standard Deviation 2.1007
|
0.595 g/L
Standard Deviation 1.9514
|
-0.171 g/L
Standard Deviation 1.9862
|
0.220 g/L
Standard Deviation 1.9687
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 8
|
-0.634 g/L
Standard Deviation 2.0094
|
0.154 g/L
Standard Deviation 2.1829
|
0.581 g/L
Standard Deviation 2.0843
|
0.077 g/L
Standard Deviation 2.2051
|
0.195 g/L
Standard Deviation 1.7638
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 12
|
0.073 g/L
Standard Deviation 2.4020
|
0.538 g/L
Standard Deviation 2.1986
|
0.857 g/L
Standard Deviation 1.8685
|
0.211 g/L
Standard Deviation 1.9474
|
0.415 g/L
Standard Deviation 2.1210
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 16
|
0.833 g/L
Standard Deviation 1.8468
|
1.132 g/L
Standard Deviation 2.2800
|
0.881 g/L
Standard Deviation 2.0025
|
0.316 g/L
Standard Deviation 2.0678
|
0.683 g/L
Standard Deviation 1.9422
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 20
|
0.175 g/L
Standard Deviation 1.9333
|
0.487 g/L
Standard Deviation 2.4047
|
0.976 g/L
Standard Deviation 1.7873
|
-0.081 g/L
Standard Deviation 2.1000
|
0.575 g/L
Standard Deviation 1.8659
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 28
|
-0.462 g/L
Standard Deviation 2.0881
|
0.632 g/L
Standard Deviation 2.1362
|
0.976 g/L
Standard Deviation 1.9169
|
0.114 g/L
Standard Deviation 1.9819
|
0.525 g/L
Standard Deviation 2.0999
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 32
|
-0.179 g/L
Standard Deviation 1.7452
|
0.359 g/L
Standard Deviation 1.8706
|
0.700 g/L
Standard Deviation 1.9897
|
-0.235 g/L
Standard Deviation 1.6341
|
0.667 g/L
Standard Deviation 1.9912
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 36
|
-0.289 g/L
Standard Deviation 2.6397
|
0.816 g/L
Standard Deviation 1.7220
|
0.659 g/L
Standard Deviation 1.6064
|
-0.029 g/L
Standard Deviation 2.0815
|
0.436 g/L
Standard Deviation 1.9166
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 40
|
-0.108 g/L
Standard Deviation 2.0109
|
0.763 g/L
Standard Deviation 1.9650
|
0.805 g/L
Standard Deviation 1.8196
|
0.000 g/L
Standard Deviation 1.8749
|
0.400 g/L
Standard Deviation 1.9716
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 44
|
-0.297 g/L
Standard Deviation 2.0120
|
0.132 g/L
Standard Deviation 2.3269
|
0.659 g/L
Standard Deviation 2.2429
|
-0.206 g/L
Standard Deviation 1.9661
|
0.175 g/L
Standard Deviation 2.2858
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Week 48
|
0.132 g/L
Standard Deviation 2.2800
|
0.632 g/L
Standard Deviation 2.9903
|
0.366 g/L
Standard Deviation 3.1682
|
0.088 g/L
Standard Deviation 2.6671
|
0.150 g/L
Standard Deviation 2.3044
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 1
|
-0.841 μmol/L
Standard Deviation 2.8968
|
-1.195 μmol/L
Standard Deviation 3.1083
|
-0.465 μmol/L
Standard Deviation 3.4868
|
0.471 μmol/L
Standard Deviation 3.0332
|
0.385 μmol/L
Standard Deviation 2.2726
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 4
|
-0.290 μmol/L
Standard Deviation 3.4900
|
0.789 μmol/L
Standard Deviation 2.8952
|
-0.119 μmol/L
Standard Deviation 3.2318
|
1.066 μmol/L
Standard Deviation 3.4454
|
1.344 μmol/L
Standard Deviation 3.7625
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 16
|
0.607 μmol/L
Standard Deviation 3.7361
|
0.637 μmol/L
Standard Deviation 3.7786
|
0.740 μmol/L
Standard Deviation 3.2505
|
1.092 μmol/L
Standard Deviation 3.7662
|
2.024 μmol/L
Standard Deviation 3.7217
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 8
|
1.366 μmol/L
Standard Deviation 8.3269
|
1.487 μmol/L
Standard Deviation 8.3756
|
3.674 μmol/L
Standard Deviation 10.1997
|
1.590 μmol/L
Standard Deviation 7.9131
|
3.073 μmol/L
Standard Deviation 5.7810
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 12
|
1.268 μmol/L
Standard Deviation 8.0282
|
0.949 μmol/L
Standard Deviation 8.6113
|
6.214 μmol/L
Standard Deviation 9.5062
|
1.947 μmol/L
Standard Deviation 9.1236
|
2.220 μmol/L
Standard Deviation 8.2417
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 16
|
1.833 μmol/L
Standard Deviation 8.4678
|
1.421 μmol/L
Standard Deviation 10.7945
|
3.738 μmol/L
Standard Deviation 7.7964
|
0.658 μmol/L
Standard Deviation 8.7897
|
3.976 μmol/L
Standard Deviation 8.2719
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 28
|
2.921 μmol/L
Standard Deviation 7.0227
|
1.737 μmol/L
Standard Deviation 7.4858
|
4.634 μmol/L
Standard Deviation 8.9576
|
1.371 μmol/L
Standard Deviation 8.3634
|
4.900 μmol/L
Standard Deviation 7.2388
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 36
|
0.289 μmol/L
Standard Deviation 7.5656
|
1.632 μmol/L
Standard Deviation 7.1600
|
1.024 μmol/L
Standard Deviation 8.8218
|
1.853 μmol/L
Standard Deviation 10.8492
|
3.462 μmol/L
Standard Deviation 6.8127
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 2
|
12.405 μmol/L
Standard Deviation 47.5795
|
-2.974 μmol/L
Standard Deviation 44.8826
|
9.791 μmol/L
Standard Deviation 61.4009
|
9.073 μmol/L
Standard Deviation 39.3430
|
15.610 μmol/L
Standard Deviation 49.0693
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 28
|
-0.897 μmol/L
Standard Deviation 29.4331
|
9.447 μmol/L
Standard Deviation 59.8655
|
18.976 μmol/L
Standard Deviation 62.4894
|
-6.371 μmol/L
Standard Deviation 40.1227
|
1.250 μmol/L
Standard Deviation 45.8972
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 2
|
-0.762 μmol/L
Standard Deviation 2.9415
|
0.492 μmol/L
Standard Deviation 3.1202
|
0.516 μmol/L
Standard Deviation 2.7030
|
0.978 μmol/L
Standard Deviation 2.9538
|
1.395 μmol/L
Standard Deviation 4.0672
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 8
|
-0.776 μmol/L
Standard Deviation 3.7242
|
0.541 μmol/L
Standard Deviation 3.1822
|
0.442 μmol/L
Standard Deviation 3.8005
|
0.972 μmol/L
Standard Deviation 3.4557
|
0.639 μmol/L
Standard Deviation 2.8243
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 12
|
-0.261 μmol/L
Standard Deviation 2.6113
|
0.341 μmol/L
Standard Deviation 3.0050
|
0.095 μmol/L
Standard Deviation 2.5793
|
0.629 μmol/L
Standard Deviation 3.2367
|
2.073 μmol/L
Standard Deviation 4.0034
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 20
|
-0.007 μmol/L
Standard Deviation 3.3543
|
0.136 μmol/L
Standard Deviation 3.4239
|
1.062 μmol/L
Standard Deviation 3.8164
|
1.030 μmol/L
Standard Deviation 3.8636
|
1.225 μmol/L
Standard Deviation 2.9632
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 24
|
0.146 μmol/L
Standard Deviation 3.2508
|
0.592 μmol/L
Standard Deviation 4.4981
|
0.383 μmol/L
Standard Deviation 3.1235
|
1.081 μmol/L
Standard Deviation 2.8708
|
1.128 μmol/L
Standard Deviation 2.8112
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 28
|
-0.200 μmol/L
Standard Deviation 3.6974
|
-0.068 μmol/L
Standard Deviation 3.8885
|
0.105 μmol/L
Standard Deviation 2.5550
|
0.449 μmol/L
Standard Deviation 3.4106
|
1.595 μmol/L
Standard Deviation 3.4093
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 32
|
0.233 μmol/L
Standard Deviation 3.2668
|
0.262 μmol/L
Standard Deviation 3.7358
|
0.655 μmol/L
Standard Deviation 3.1125
|
0.994 μmol/L
Standard Deviation 2.6879
|
1.669 μmol/L
Standard Deviation 4.0868
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 36
|
0.942 μmol/L
Standard Deviation 3.6870
|
0.776 μmol/L
Standard Deviation 4.3703
|
0.078 μmol/L
Standard Deviation 3.8443
|
1.012 μmol/L
Standard Deviation 3.5311
|
1.095 μmol/L
Standard Deviation 2.3971
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 40
|
0.600 μmol/L
Standard Deviation 3.8064
|
0.679 μmol/L
Standard Deviation 3.4707
|
0.415 μmol/L
Standard Deviation 3.3481
|
1.065 μmol/L
Standard Deviation 3.1718
|
1.433 μmol/L
Standard Deviation 3.3425
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 44
|
-0.019 μmol/L
Standard Deviation 3.6800
|
-0.276 μmol/L
Standard Deviation 3.1827
|
-0.102 μmol/L
Standard Deviation 3.1253
|
0.871 μmol/L
Standard Deviation 2.8347
|
1.851 μmol/L
Standard Deviation 3.7976
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin Week 48
|
0.716 μmol/L
Standard Deviation 4.0370
|
0.559 μmol/L
Standard Deviation 3.2460
|
0.285 μmol/L
Standard Deviation 3.8393
|
1.124 μmol/L
Standard Deviation 3.2882
|
1.160 μmol/L
Standard Deviation 3.9493
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 1
|
-0.512 μmol/L
Standard Deviation 6.6788
|
0.368 μmol/L
Standard Deviation 7.3757
|
2.442 μmol/L
Standard Deviation 7.8628
|
1.366 μmol/L
Standard Deviation 8.9044
|
1.300 μmol/L
Standard Deviation 6.7300
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 2
|
2.310 μmol/L
Standard Deviation 11.1300
|
0.026 μmol/L
Standard Deviation 6.1194
|
2.093 μmol/L
Standard Deviation 8.4426
|
2.537 μmol/L
Standard Deviation 6.8304
|
3.317 μmol/L
Standard Deviation 6.7470
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 4
|
0.854 μmol/L
Standard Deviation 10.2508
|
1.256 μmol/L
Standard Deviation 7.0812
|
1.762 μmol/L
Standard Deviation 8.8229
|
-0.561 μmol/L
Standard Deviation 7.3418
|
2.171 μmol/L
Standard Deviation 6.9279
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 20
|
3.150 μmol/L
Standard Deviation 8.3468
|
1.051 μmol/L
Standard Deviation 7.7966
|
4.976 μmol/L
Standard Deviation 10.5818
|
2.270 μmol/L
Standard Deviation 8.5461
|
4.525 μmol/L
Standard Deviation 7.4144
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 24
|
1.359 μmol/L
Standard Deviation 8.1741
|
0.103 μmol/L
Standard Deviation 6.8817
|
3.829 μmol/L
Standard Deviation 11.4256
|
1.972 μmol/L
Standard Deviation 9.3914
|
4.650 μmol/L
Standard Deviation 7.2627
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 32
|
1.718 μmol/L
Standard Deviation 8.8227
|
2.462 μmol/L
Standard Deviation 9.1360
|
2.500 μmol/L
Standard Deviation 8.9299
|
4.118 μmol/L
Standard Deviation 12.0825
|
4.974 μmol/L
Standard Deviation 7.7408
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 40
|
3.838 μmol/L
Standard Deviation 9.5205
|
2.974 μmol/L
Standard Deviation 7.3796
|
4.122 μmol/L
Standard Deviation 9.7575
|
0.647 μmol/L
Standard Deviation 10.7672
|
3.200 μmol/L
Standard Deviation 7.0208
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 44
|
4.543 μmol/L
Standard Deviation 10.6670
|
4.250 μmol/L
Standard Deviation 8.7876
|
3.659 μmol/L
Standard Deviation 8.5311
|
3.364 μmol/L
Standard Deviation 10.6853
|
3.925 μmol/L
Standard Deviation 8.0012
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Creatinine Week 48
|
3.000 μmol/L
Standard Deviation 10.3299
|
4.667 μmol/L
Standard Deviation 8.5355
|
3.923 μmol/L
Standard Deviation 7.7371
|
2.879 μmol/L
Standard Deviation 9.8513
|
3.256 μmol/L
Standard Deviation 7.0290
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 1
|
-1.220 μmol/L
Standard Deviation 37.4503
|
-0.237 μmol/L
Standard Deviation 43.0100
|
11.953 μmol/L
Standard Deviation 60.5652
|
8.732 μmol/L
Standard Deviation 39.4088
|
11.650 μmol/L
Standard Deviation 61.0924
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 4
|
10.171 μmol/L
Standard Deviation 41.5493
|
0.308 μmol/L
Standard Deviation 47.3193
|
13.452 μmol/L
Standard Deviation 49.1633
|
5.659 μmol/L
Standard Deviation 31.2591
|
-4.293 μmol/L
Standard Deviation 47.5753
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 8
|
5.415 μmol/L
Standard Deviation 42.9500
|
-6.231 μmol/L
Standard Deviation 40.4198
|
11.791 μmol/L
Standard Deviation 64.9910
|
3.410 μmol/L
Standard Deviation 33.9518
|
8.024 μmol/L
Standard Deviation 44.0043
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 12
|
10.707 μmol/L
Standard Deviation 40.2208
|
6.795 μmol/L
Standard Deviation 54.4814
|
13.881 μmol/L
Standard Deviation 55.3332
|
7.553 μmol/L
Standard Deviation 33.4904
|
2.805 μmol/L
Standard Deviation 37.6651
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 16
|
25.810 μmol/L
Standard Deviation 44.1965
|
8.079 μmol/L
Standard Deviation 50.0062
|
15.357 μmol/L
Standard Deviation 59.0311
|
14.026 μmol/L
Standard Deviation 40.5173
|
21.683 μmol/L
Standard Deviation 41.1670
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 20
|
28.950 μmol/L
Standard Deviation 53.8602
|
4.692 μmol/L
Standard Deviation 59.0420
|
16.048 μmol/L
Standard Deviation 63.4346
|
10.622 μmol/L
Standard Deviation 42.1567
|
10.600 μmol/L
Standard Deviation 44.3262
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 24
|
17.410 μmol/L
Standard Deviation 45.0045
|
9.923 μmol/L
Standard Deviation 54.9648
|
3.683 μmol/L
Standard Deviation 58.6977
|
6.667 μmol/L
Standard Deviation 45.2580
|
6.950 μmol/L
Standard Deviation 45.8638
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 32
|
17.026 μmol/L
Standard Deviation 47.8185
|
2.821 μmol/L
Standard Deviation 48.9042
|
5.800 μmol/L
Standard Deviation 56.2017
|
3.971 μmol/L
Standard Deviation 45.1103
|
17.077 μmol/L
Standard Deviation 40.3089
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 36
|
0.211 μmol/L
Standard Deviation 37.5630
|
-4.868 μmol/L
Standard Deviation 49.1419
|
-10.927 μmol/L
Standard Deviation 59.4228
|
4.735 μmol/L
Standard Deviation 42.4309
|
5.846 μmol/L
Standard Deviation 49.4259
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 40
|
9.730 μmol/L
Standard Deviation 43.5295
|
15.605 μmol/L
Standard Deviation 53.8931
|
9.976 μmol/L
Standard Deviation 62.8739
|
-5.029 μmol/L
Standard Deviation 41.2630
|
7.255 μmol/L
Standard Deviation 46.0833
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 44
|
20.541 μmol/L
Standard Deviation 57.9164
|
7.605 μmol/L
Standard Deviation 64.3342
|
-8.854 μmol/L
Standard Deviation 67.3523
|
1.382 μmol/L
Standard Deviation 47.9558
|
10.675 μmol/L
Standard Deviation 50.8963
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Urate Week 48
|
8.684 μmol/L
Standard Deviation 53.6208
|
3.895 μmol/L
Standard Deviation 48.5831
|
-3.220 μmol/L
Standard Deviation 64.9282
|
1.853 μmol/L
Standard Deviation 54.8762
|
8.050 μmol/L
Standard Deviation 49.1956
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 1
|
-0.034 mmol/L
Standard Deviation 0.0810
|
-0.017 mmol/L
Standard Deviation 0.0984
|
-0.008 mmol/L
Standard Deviation 0.0858
|
-0.002 mmol/L
Standard Deviation 0.0990
|
-0.014 mmol/L
Standard Deviation 0.0897
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 4
|
-0.029 mmol/L
Standard Deviation 0.1079
|
-0.011 mmol/L
Standard Deviation 0.1015
|
-0.021 mmol/L
Standard Deviation 0.0973
|
-0.047 mmol/L
Standard Deviation 0.1147
|
-0.020 mmol/L
Standard Deviation 0.0917
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 24
|
0.011 mmol/L
Standard Deviation 0.1019
|
-0.002 mmol/L
Standard Deviation 0.1028
|
0.015 mmol/L
Standard Deviation 0.0845
|
0.004 mmol/L
Standard Deviation 0.0896
|
0.003 mmol/L
Standard Deviation 0.0974
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 32
|
-0.023 mmol/L
Standard Deviation 0.1069
|
0.000 mmol/L
Standard Deviation 0.0952
|
0.001 mmol/L
Standard Deviation 0.1074
|
-0.017 mmol/L
Standard Deviation 0.0932
|
-0.008 mmol/L
Standard Deviation 0.1024
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 40
|
0.003 mmol/L
Standard Deviation 0.0905
|
0.001 mmol/L
Standard Deviation 0.0807
|
-0.007 mmol/L
Standard Deviation 0.1084
|
-0.019 mmol/L
Standard Deviation 0.0809
|
-0.025 mmol/L
Standard Deviation 0.0947
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 1
|
-0.195 mmol/L
Standard Deviation 2.1121
|
-0.105 mmol/L
Standard Deviation 2.5446
|
-0.674 mmol/L
Standard Deviation 4.1388
|
-0.244 mmol/L
Standard Deviation 2.5572
|
-0.125 mmol/L
Standard Deviation 2.3986
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 44
|
-0.170 mmol/L
Standard Deviation 0.8082
|
-0.176 mmol/L
Standard Deviation 1.0874
|
0.071 mmol/L
Standard Deviation 0.9341
|
-0.218 mmol/L
Standard Deviation 0.9150
|
-0.000 mmol/L
Standard Deviation 0.8407
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 36
|
0.089 mmol/L
Standard Deviation 0.9061
|
0.342 mmol/L
Standard Deviation 0.9406
|
0.234 mmol/L
Standard Deviation 1.0379
|
0.174 mmol/L
Standard Deviation 1.0175
|
0.290 mmol/L
Standard Deviation 0.7789
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 28
|
-0.027 mmol/L
Standard Deviation 0.0713
|
-0.007 mmol/L
Standard Deviation 0.0525
|
-0.018 mmol/L
Standard Deviation 0.0678
|
-0.019 mmol/L
Standard Deviation 0.0719
|
-0.017 mmol/L
Standard Deviation 0.0565
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 2
|
-0.098 mmol/L
Standard Deviation 0.2975
|
0.085 mmol/L
Standard Deviation 0.4095
|
0.002 mmol/L
Standard Deviation 0.3327
|
-0.005 mmol/L
Standard Deviation 0.3521
|
0.027 mmol/L
Standard Deviation 0.3074
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 24
|
-0.095 mmol/L
Standard Deviation 0.3308
|
-0.072 mmol/L
Standard Deviation 0.3052
|
0.030 mmol/L
Standard Deviation 0.3844
|
-0.094 mmol/L
Standard Deviation 0.3414
|
-0.062 mmol/L
Standard Deviation 0.2967
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 28
|
-0.462 mmol/L
Standard Deviation 2.2924
|
-0.658 mmol/L
Standard Deviation 1.8494
|
-0.683 mmol/L
Standard Deviation 1.8767
|
-0.457 mmol/L
Standard Deviation 2.3307
|
-0.575 mmol/L
Standard Deviation 2.5609
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 32
|
-1.077 mmol/L
Standard Deviation 1.8692
|
-0.128 mmol/L
Standard Deviation 1.9219
|
-0.525 mmol/L
Standard Deviation 1.8809
|
-0.441 mmol/L
Standard Deviation 1.6732
|
-0.667 mmol/L
Standard Deviation 1.8257
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 44
|
-0.486 mmol/L
Standard Deviation 1.8352
|
-0.737 mmol/L
Standard Deviation 2.0492
|
-0.878 mmol/L
Standard Deviation 1.9390
|
-0.647 mmol/L
Standard Deviation 1.8238
|
-1.000 mmol/L
Standard Deviation 2.4179
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 2
|
-0.021 mmol/L
Standard Deviation 0.0951
|
0.002 mmol/L
Standard Deviation 0.0973
|
0.009 mmol/L
Standard Deviation 0.1304
|
-0.024 mmol/L
Standard Deviation 0.1001
|
-0.022 mmol/L
Standard Deviation 0.0938
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 8
|
-0.024 mmol/L
Standard Deviation 0.0942
|
-0.006 mmol/L
Standard Deviation 0.0926
|
0.008 mmol/L
Standard Deviation 0.1260
|
-0.004 mmol/L
Standard Deviation 0.1105
|
-0.022 mmol/L
Standard Deviation 0.0975
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 12
|
-0.021 mmol/L
Standard Deviation 0.1009
|
-0.025 mmol/L
Standard Deviation 0.1090
|
0.021 mmol/L
Standard Deviation 0.1057
|
-0.020 mmol/L
Standard Deviation 0.1088
|
-0.025 mmol/L
Standard Deviation 0.0923
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 16
|
0.004 mmol/L
Standard Deviation 0.0826
|
-0.006 mmol/L
Standard Deviation 0.1079
|
0.023 mmol/L
Standard Deviation 0.1334
|
-0.004 mmol/L
Standard Deviation 0.1027
|
0.005 mmol/L
Standard Deviation 0.0888
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 20
|
0.002 mmol/L
Standard Deviation 0.0931
|
0.000 mmol/L
Standard Deviation 0.1013
|
0.017 mmol/L
Standard Deviation 0.0999
|
-0.008 mmol/L
Standard Deviation 0.0948
|
-0.018 mmol/L
Standard Deviation 0.0919
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 28
|
-0.027 mmol/L
Standard Deviation 0.1117
|
0.002 mmol/L
Standard Deviation 0.0877
|
0.009 mmol/L
Standard Deviation 0.1068
|
0.008 mmol/L
Standard Deviation 0.0909
|
-0.021 mmol/L
Standard Deviation 0.1043
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 36
|
-0.013 mmol/L
Standard Deviation 0.1172
|
0.007 mmol/L
Standard Deviation 0.0804
|
-0.005 mmol/L
Standard Deviation 0.1096
|
0.001 mmol/L
Standard Deviation 0.0972
|
-0.015 mmol/L
Standard Deviation 0.0936
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 44
|
-0.027 mmol/L
Standard Deviation 0.0920
|
-0.018 mmol/L
Standard Deviation 0.0861
|
-0.008 mmol/L
Standard Deviation 0.1023
|
-0.019 mmol/L
Standard Deviation 0.0839
|
-0.042 mmol/L
Standard Deviation 0.0972
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium Week 48
|
-0.010 mmol/L
Standard Deviation 0.0881
|
-0.009 mmol/L
Standard Deviation 0.1033
|
-0.014 mmol/L
Standard Deviation 0.1126
|
-0.014 mmol/L
Standard Deviation 0.0912
|
-0.034 mmol/L
Standard Deviation 0.0861
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 2
|
-0.214 mmol/L
Standard Deviation 2.1131
|
0.308 mmol/L
Standard Deviation 2.6273
|
0.093 mmol/L
Standard Deviation 2.7500
|
0.415 mmol/L
Standard Deviation 2.5296
|
-0.439 mmol/L
Standard Deviation 2.4192
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 4
|
-0.293 mmol/L
Standard Deviation 1.9525
|
-0.333 mmol/L
Standard Deviation 2.2750
|
0.000 mmol/L
Standard Deviation 2.4792
|
0.024 mmol/L
Standard Deviation 2.6409
|
0.000 mmol/L
Standard Deviation 2.6363
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 8
|
-0.537 mmol/L
Standard Deviation 2.1920
|
0.615 mmol/L
Standard Deviation 2.4346
|
0.047 mmol/L
Standard Deviation 2.6988
|
0.538 mmol/L
Standard Deviation 2.3038
|
0.683 mmol/L
Standard Deviation 2.4025
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 12
|
0.341 mmol/L
Standard Deviation 2.2205
|
-0.282 mmol/L
Standard Deviation 2.3946
|
0.548 mmol/L
Standard Deviation 2.5681
|
-0.211 mmol/L
Standard Deviation 2.3499
|
0.000 mmol/L
Standard Deviation 2.4393
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 16
|
-0.310 mmol/L
Standard Deviation 1.8934
|
0.026 mmol/L
Standard Deviation 2.2837
|
0.190 mmol/L
Standard Deviation 2.0864
|
-0.184 mmol/L
Standard Deviation 2.2644
|
-0.268 mmol/L
Standard Deviation 2.1334
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 20
|
-0.325 mmol/L
Standard Deviation 2.4640
|
-0.538 mmol/L
Standard Deviation 2.1502
|
0.262 mmol/L
Standard Deviation 2.3484
|
0.162 mmol/L
Standard Deviation 2.6616
|
0.075 mmol/L
Standard Deviation 2.3685
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 24
|
-0.615 mmol/L
Standard Deviation 2.0081
|
-0.128 mmol/L
Standard Deviation 2.5462
|
-0.390 mmol/L
Standard Deviation 2.6351
|
-0.306 mmol/L
Standard Deviation 2.1885
|
-0.050 mmol/L
Standard Deviation 2.5415
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 28
|
0.128 mmol/L
Standard Deviation 2.3190
|
0.000 mmol/L
Standard Deviation 2.6913
|
0.195 mmol/L
Standard Deviation 2.3154
|
0.086 mmol/L
Standard Deviation 2.5365
|
0.250 mmol/L
Standard Deviation 2.5090
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 32
|
-0.154 mmol/L
Standard Deviation 2.2069
|
0.436 mmol/L
Standard Deviation 2.3708
|
0.500 mmol/L
Standard Deviation 2.2072
|
0.794 mmol/L
Standard Deviation 2.3196
|
0.282 mmol/L
Standard Deviation 2.0641
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 36
|
0.237 mmol/L
Standard Deviation 1.9923
|
0.684 mmol/L
Standard Deviation 2.4285
|
0.732 mmol/L
Standard Deviation 1.9239
|
0.294 mmol/L
Standard Deviation 2.5999
|
0.205 mmol/L
Standard Deviation 2.4299
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 40
|
-0.054 mmol/L
Standard Deviation 2.5380
|
0.263 mmol/L
Standard Deviation 2.6271
|
0.707 mmol/L
Standard Deviation 2.4418
|
0.824 mmol/L
Standard Deviation 2.4676
|
0.500 mmol/L
Standard Deviation 2.4495
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 44
|
0.135 mmol/L
Standard Deviation 1.9027
|
0.579 mmol/L
Standard Deviation 2.6977
|
0.756 mmol/L
Standard Deviation 2.1069
|
0.882 mmol/L
Standard Deviation 2.8044
|
0.200 mmol/L
Standard Deviation 2.5840
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Chloride Week 48
|
0.605 mmol/L
Standard Deviation 2.0994
|
0.737 mmol/L
Standard Deviation 2.8158
|
1.024 mmol/L
Standard Deviation 2.4545
|
0.971 mmol/L
Standard Deviation 2.5044
|
0.725 mmol/L
Standard Deviation 2.7826
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 1
|
-0.254 mmol/L
Standard Deviation 0.4371
|
0.032 mmol/L
Standard Deviation 0.4307
|
0.244 mmol/L
Standard Deviation 0.5220
|
0.105 mmol/L
Standard Deviation 0.4690
|
0.102 mmol/L
Standard Deviation 0.3965
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 2
|
-0.224 mmol/L
Standard Deviation 0.4154
|
0.108 mmol/L
Standard Deviation 0.5132
|
0.295 mmol/L
Standard Deviation 0.5178
|
0.054 mmol/L
Standard Deviation 0.5441
|
0.222 mmol/L
Standard Deviation 0.6101
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 4
|
-0.198 mmol/L
Standard Deviation 0.6334
|
-0.023 mmol/L
Standard Deviation 0.5905
|
0.210 mmol/L
Standard Deviation 0.8027
|
0.093 mmol/L
Standard Deviation 0.6525
|
0.151 mmol/L
Standard Deviation 0.4178
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 8
|
-0.190 mmol/L
Standard Deviation 0.6935
|
-0.023 mmol/L
Standard Deviation 0.5770
|
0.284 mmol/L
Standard Deviation 0.8012
|
0.074 mmol/L
Standard Deviation 0.7920
|
0.061 mmol/L
Standard Deviation 0.6268
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 12
|
-0.124 mmol/L
Standard Deviation 0.6719
|
0.013 mmol/L
Standard Deviation 0.7473
|
0.117 mmol/L
Standard Deviation 0.7616
|
0.005 mmol/L
Standard Deviation 0.6045
|
0.212 mmol/L
Standard Deviation 0.7491
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 16
|
0.095 mmol/L
Standard Deviation 0.6811
|
0.184 mmol/L
Standard Deviation 0.6378
|
0.138 mmol/L
Standard Deviation 0.6814
|
0.068 mmol/L
Standard Deviation 0.6014
|
0.249 mmol/L
Standard Deviation 0.7075
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 20
|
0.053 mmol/L
Standard Deviation 0.7609
|
0.126 mmol/L
Standard Deviation 0.6889
|
0.186 mmol/L
Standard Deviation 0.9669
|
0.116 mmol/L
Standard Deviation 0.7101
|
0.115 mmol/L
Standard Deviation 0.7718
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 24
|
0.041 mmol/L
Standard Deviation 0.8729
|
0.013 mmol/L
Standard Deviation 0.8673
|
0.127 mmol/L
Standard Deviation 1.0682
|
-0.003 mmol/L
Standard Deviation 0.6984
|
0.077 mmol/L
Standard Deviation 0.5686
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 28
|
-0.044 mmol/L
Standard Deviation 0.9797
|
-0.037 mmol/L
Standard Deviation 0.8930
|
0.076 mmol/L
Standard Deviation 1.1434
|
-0.037 mmol/L
Standard Deviation 0.5801
|
0.100 mmol/L
Standard Deviation 0.5923
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 32
|
-0.085 mmol/L
Standard Deviation 0.8540
|
-0.079 mmol/L
Standard Deviation 0.8918
|
0.175 mmol/L
Standard Deviation 1.0895
|
-0.050 mmol/L
Standard Deviation 0.5945
|
0.256 mmol/L
Standard Deviation 0.6920
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 36
|
0.005 mmol/L
Standard Deviation 0.7322
|
0.024 mmol/L
Standard Deviation 0.7951
|
0.117 mmol/L
Standard Deviation 0.8408
|
-0.038 mmol/L
Standard Deviation 0.6597
|
0.144 mmol/L
Standard Deviation 0.7950
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 40
|
-0.103 mmol/L
Standard Deviation 0.7541
|
-0.118 mmol/L
Standard Deviation 0.9109
|
0.183 mmol/L
Standard Deviation 0.8947
|
-0.135 mmol/L
Standard Deviation 0.7454
|
0.110 mmol/L
Standard Deviation 0.7824
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Cholesterol Week 48
|
-0.282 mmol/L
Standard Deviation 0.7891
|
-0.279 mmol/L
Standard Deviation 0.8348
|
0.012 mmol/L
Standard Deviation 0.8883
|
-0.253 mmol/L
Standard Deviation 0.6653
|
-0.083 mmol/L
Standard Deviation 0.5817
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 1
|
0.307 mmol/L
Standard Deviation 1.3942
|
0.103 mmol/L
Standard Deviation 0.7027
|
0.077 mmol/L
Standard Deviation 1.1366
|
0.173 mmol/L
Standard Deviation 1.0232
|
-0.060 mmol/L
Standard Deviation 0.8445
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 2
|
0.062 mmol/L
Standard Deviation 0.6681
|
0.013 mmol/L
Standard Deviation 0.8348
|
0.221 mmol/L
Standard Deviation 0.9652
|
0.129 mmol/L
Standard Deviation 1.2364
|
0.190 mmol/L
Standard Deviation 0.8938
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 4
|
0.298 mmol/L
Standard Deviation 0.8575
|
0.015 mmol/L
Standard Deviation 0.6888
|
0.248 mmol/L
Standard Deviation 0.7693
|
0.249 mmol/L
Standard Deviation 1.0659
|
0.134 mmol/L
Standard Deviation 0.7428
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 8
|
0.112 mmol/L
Standard Deviation 0.9127
|
0.308 mmol/L
Standard Deviation 0.7696
|
0.258 mmol/L
Standard Deviation 0.9254
|
0.344 mmol/L
Standard Deviation 0.6939
|
0.256 mmol/L
Standard Deviation 0.7075
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 12
|
0.110 mmol/L
Standard Deviation 0.9146
|
0.005 mmol/L
Standard Deviation 0.6117
|
0.188 mmol/L
Standard Deviation 0.7533
|
0.111 mmol/L
Standard Deviation 0.6455
|
-0.124 mmol/L
Standard Deviation 0.6636
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 16
|
0.176 mmol/L
Standard Deviation 0.8363
|
0.195 mmol/L
Standard Deviation 0.6316
|
0.424 mmol/L
Standard Deviation 1.1521
|
0.276 mmol/L
Standard Deviation 0.8280
|
0.398 mmol/L
Standard Deviation 0.8332
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 20
|
0.208 mmol/L
Standard Deviation 1.0560
|
0.315 mmol/L
Standard Deviation 1.0225
|
0.267 mmol/L
Standard Deviation 1.0132
|
0.632 mmol/L
Standard Deviation 0.9741
|
0.165 mmol/L
Standard Deviation 1.0366
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 24
|
0.018 mmol/L
Standard Deviation 1.1856
|
0.092 mmol/L
Standard Deviation 0.7747
|
0.328 mmol/L
Standard Deviation 0.8554
|
0.061 mmol/L
Standard Deviation 1.0462
|
0.037 mmol/L
Standard Deviation 0.6295
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 28
|
0.246 mmol/L
Standard Deviation 1.1812
|
0.263 mmol/L
Standard Deviation 0.9371
|
0.322 mmol/L
Standard Deviation 1.1372
|
0.263 mmol/L
Standard Deviation 1.0053
|
0.262 mmol/L
Standard Deviation 0.6412
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 32
|
0.333 mmol/L
Standard Deviation 1.2671
|
0.236 mmol/L
Standard Deviation 0.7013
|
0.570 mmol/L
Standard Deviation 1.0301
|
0.356 mmol/L
Standard Deviation 1.1021
|
0.203 mmol/L
Standard Deviation 0.5945
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 40
|
0.143 mmol/L
Standard Deviation 1.0885
|
0.245 mmol/L
Standard Deviation 1.1081
|
0.507 mmol/L
Standard Deviation 1.1257
|
0.203 mmol/L
Standard Deviation 0.7420
|
0.125 mmol/L
Standard Deviation 0.7016
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 44
|
0.222 mmol/L
Standard Deviation 1.4919
|
0.200 mmol/L
Standard Deviation 1.0950
|
0.185 mmol/L
Standard Deviation 0.8688
|
0.303 mmol/L
Standard Deviation 1.2760
|
0.197 mmol/L
Standard Deviation 0.8966
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Glucose Week 48
|
-0.013 mmol/L
Standard Deviation 1.2512
|
0.045 mmol/L
Standard Deviation 0.8472
|
0.141 mmol/L
Standard Deviation 0.9341
|
0.276 mmol/L
Standard Deviation 1.0841
|
0.100 mmol/L
Standard Deviation 0.7835
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 1
|
-0.010 mmol/L
Standard Deviation 0.0672
|
-0.007 mmol/L
Standard Deviation 0.0676
|
0.002 mmol/L
Standard Deviation 0.0694
|
-0.014 mmol/L
Standard Deviation 0.0573
|
-0.015 mmol/L
Standard Deviation 0.0680
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 2
|
-0.004 mmol/L
Standard Deviation 0.0795
|
0.008 mmol/L
Standard Deviation 0.0745
|
-0.011 mmol/L
Standard Deviation 0.0771
|
-0.019 mmol/L
Standard Deviation 0.0624
|
-0.007 mmol/L
Standard Deviation 0.0680
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 4
|
-0.022 mmol/L
Standard Deviation 0.0606
|
0.009 mmol/L
Standard Deviation 0.0725
|
-0.012 mmol/L
Standard Deviation 0.0789
|
-0.020 mmol/L
Standard Deviation 0.0712
|
-0.005 mmol/L
Standard Deviation 0.0998
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 8
|
-0.016 mmol/L
Standard Deviation 0.0706
|
-0.008 mmol/L
Standard Deviation 0.0593
|
-0.013 mmol/L
Standard Deviation 0.0819
|
-0.015 mmol/L
Standard Deviation 0.0706
|
-0.006 mmol/L
Standard Deviation 0.0624
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 12
|
0.010 mmol/L
Standard Deviation 0.0797
|
0.008 mmol/L
Standard Deviation 0.0847
|
-0.011 mmol/L
Standard Deviation 0.0733
|
-0.001 mmol/L
Standard Deviation 0.0660
|
0.003 mmol/L
Standard Deviation 0.0730
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 16
|
-0.002 mmol/L
Standard Deviation 0.0742
|
0.003 mmol/L
Standard Deviation 0.0823
|
-0.021 mmol/L
Standard Deviation 0.0659
|
-0.009 mmol/L
Standard Deviation 0.0629
|
-0.002 mmol/L
Standard Deviation 0.0731
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 20
|
-0.007 mmol/L
Standard Deviation 0.0811
|
-0.012 mmol/L
Standard Deviation 0.0728
|
-0.018 mmol/L
Standard Deviation 0.0659
|
-0.005 mmol/L
Standard Deviation 0.0724
|
-0.009 mmol/L
Standard Deviation 0.0636
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 24
|
-0.005 mmol/L
Standard Deviation 0.0757
|
-0.004 mmol/L
Standard Deviation 0.0572
|
-0.014 mmol/L
Standard Deviation 0.0732
|
-0.009 mmol/L
Standard Deviation 0.0559
|
-0.016 mmol/L
Standard Deviation 0.0664
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 32
|
-0.023 mmol/L
Standard Deviation 0.0727
|
-0.016 mmol/L
Standard Deviation 0.0641
|
-0.016 mmol/L
Standard Deviation 0.0603
|
-0.012 mmol/L
Standard Deviation 0.0670
|
-0.013 mmol/L
Standard Deviation 0.0572
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 36
|
-0.015 mmol/L
Standard Deviation 0.0694
|
-0.001 mmol/L
Standard Deviation 0.0596
|
-0.031 mmol/L
Standard Deviation 0.0698
|
-0.004 mmol/L
Standard Deviation 0.0534
|
-0.007 mmol/L
Standard Deviation 0.0563
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 40
|
-0.032 mmol/L
Standard Deviation 0.0681
|
-0.007 mmol/L
Standard Deviation 0.0541
|
-0.014 mmol/L
Standard Deviation 0.0754
|
-0.024 mmol/L
Standard Deviation 0.0636
|
-0.009 mmol/L
Standard Deviation 0.0684
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 44
|
-0.024 mmol/L
Standard Deviation 0.0677
|
-0.000 mmol/L
Standard Deviation 0.0597
|
-0.009 mmol/L
Standard Deviation 0.0685
|
-0.024 mmol/L
Standard Deviation 0.0668
|
-0.016 mmol/L
Standard Deviation 0.0667
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Magnesium Week 48
|
-0.004 mmol/L
Standard Deviation 0.0633
|
-0.004 mmol/L
Standard Deviation 0.0546
|
-0.014 mmol/L
Standard Deviation 0.0569
|
-0.006 mmol/L
Standard Deviation 0.0616
|
-0.009 mmol/L
Standard Deviation 0.0648
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 1
|
-0.095 mmol/L
Standard Deviation 0.2701
|
0.089 mmol/L
Standard Deviation 0.3608
|
0.081 mmol/L
Standard Deviation 0.4289
|
-0.017 mmol/L
Standard Deviation 0.3098
|
-0.062 mmol/L
Standard Deviation 0.3216
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 4
|
-0.080 mmol/L
Standard Deviation 0.2522
|
0.008 mmol/L
Standard Deviation 0.3821
|
0.026 mmol/L
Standard Deviation 0.2632
|
0.024 mmol/L
Standard Deviation 0.4030
|
-0.063 mmol/L
Standard Deviation 0.2853
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 8
|
-0.056 mmol/L
Standard Deviation 0.2907
|
0.069 mmol/L
Standard Deviation 0.3221
|
0.014 mmol/L
Standard Deviation 0.3306
|
-0.010 mmol/L
Standard Deviation 0.3135
|
0.000 mmol/L
Standard Deviation 0.2520
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 12
|
-0.073 mmol/L
Standard Deviation 0.3217
|
0.033 mmol/L
Standard Deviation 0.3398
|
-0.024 mmol/L
Standard Deviation 0.3192
|
-0.082 mmol/L
Standard Deviation 0.3074
|
-0.080 mmol/L
Standard Deviation 0.2977
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 16
|
-0.086 mmol/L
Standard Deviation 0.3258
|
0.083 mmol/L
Standard Deviation 0.3112
|
0.012 mmol/L
Standard Deviation 0.3651
|
-0.037 mmol/L
Standard Deviation 0.3035
|
-0.020 mmol/L
Standard Deviation 0.2713
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 20
|
-0.092 mmol/L
Standard Deviation 0.3846
|
0.031 mmol/L
Standard Deviation 0.3381
|
0.055 mmol/L
Standard Deviation 0.3494
|
-0.019 mmol/L
Standard Deviation 0.3627
|
0.000 mmol/L
Standard Deviation 0.2774
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 28
|
-0.077 mmol/L
Standard Deviation 0.3141
|
0.105 mmol/L
Standard Deviation 0.3616
|
0.063 mmol/L
Standard Deviation 0.4265
|
-0.003 mmol/L
Standard Deviation 0.3312
|
-0.030 mmol/L
Standard Deviation 0.3480
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 32
|
-0.062 mmol/L
Standard Deviation 0.3306
|
0.069 mmol/L
Standard Deviation 0.3621
|
0.023 mmol/L
Standard Deviation 0.4154
|
0.056 mmol/L
Standard Deviation 0.2688
|
0.046 mmol/L
Standard Deviation 0.3094
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 36
|
-0.092 mmol/L
Standard Deviation 0.3388
|
0.045 mmol/L
Standard Deviation 0.3689
|
0.066 mmol/L
Standard Deviation 0.4316
|
0.003 mmol/L
Standard Deviation 0.3205
|
0.033 mmol/L
Standard Deviation 0.3359
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 40
|
-0.092 mmol/L
Standard Deviation 0.3616
|
0.089 mmol/L
Standard Deviation 0.3826
|
0.024 mmol/L
Standard Deviation 0.3484
|
-0.003 mmol/L
Standard Deviation 0.3407
|
-0.017 mmol/L
Standard Deviation 0.3456
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 44
|
-0.119 mmol/L
Standard Deviation 0.2933
|
0.029 mmol/L
Standard Deviation 0.3571
|
0.068 mmol/L
Standard Deviation 0.4344
|
0.094 mmol/L
Standard Deviation 0.3084
|
-0.035 mmol/L
Standard Deviation 0.3009
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Potassium Week 48
|
-0.137 mmol/L
Standard Deviation 0.3627
|
-0.053 mmol/L
Standard Deviation 0.3244
|
-0.032 mmol/L
Standard Deviation 0.3274
|
0.003 mmol/L
Standard Deviation 0.4123
|
-0.027 mmol/L
Standard Deviation 0.3250
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 1
|
-0.146 mmol/L
Standard Deviation 1.5582
|
-0.184 mmol/L
Standard Deviation 1.7531
|
0.000 mmol/L
Standard Deviation 2.0471
|
-0.610 mmol/L
Standard Deviation 2.0722
|
-0.375 mmol/L
Standard Deviation 2.1326
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 2
|
-0.500 mmol/L
Standard Deviation 1.6417
|
-0.513 mmol/L
Standard Deviation 1.8191
|
-0.209 mmol/L
Standard Deviation 1.9341
|
-0.244 mmol/L
Standard Deviation 2.0221
|
-0.341 mmol/L
Standard Deviation 2.1167
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 4
|
-0.732 mmol/L
Standard Deviation 1.8442
|
-0.385 mmol/L
Standard Deviation 1.6482
|
-0.214 mmol/L
Standard Deviation 2.3430
|
-0.707 mmol/L
Standard Deviation 2.0155
|
-0.805 mmol/L
Standard Deviation 1.8196
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 8
|
-0.854 mmol/L
Standard Deviation 2.0070
|
-0.410 mmol/L
Standard Deviation 1.3711
|
-0.860 mmol/L
Standard Deviation 2.2316
|
-0.359 mmol/L
Standard Deviation 1.7394
|
-0.463 mmol/L
Standard Deviation 2.2924
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 12
|
-0.512 mmol/L
Standard Deviation 1.8858
|
-0.513 mmol/L
Standard Deviation 1.4845
|
-0.619 mmol/L
Standard Deviation 2.0357
|
-0.632 mmol/L
Standard Deviation 2.1738
|
-0.854 mmol/L
Standard Deviation 2.3512
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 16
|
-0.738 mmol/L
Standard Deviation 1.8086
|
-0.211 mmol/L
Standard Deviation 1.7423
|
-0.714 mmol/L
Standard Deviation 1.7708
|
-0.842 mmol/L
Standard Deviation 2.3656
|
-0.780 mmol/L
Standard Deviation 1.7250
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 20
|
-0.675 mmol/L
Standard Deviation 1.7155
|
-0.538 mmol/L
Standard Deviation 1.4482
|
-0.857 mmol/L
Standard Deviation 2.1928
|
-0.595 mmol/L
Standard Deviation 2.1661
|
-0.775 mmol/L
Standard Deviation 1.9147
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 24
|
-0.821 mmol/L
Standard Deviation 1.7751
|
-0.487 mmol/L
Standard Deviation 1.5196
|
-0.463 mmol/L
Standard Deviation 2.0137
|
-0.472 mmol/L
Standard Deviation 1.8124
|
-0.725 mmol/L
Standard Deviation 1.7393
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 36
|
-0.711 mmol/L
Standard Deviation 2.0122
|
-0.263 mmol/L
Standard Deviation 1.8986
|
-0.512 mmol/L
Standard Deviation 1.8725
|
-0.618 mmol/L
Standard Deviation 1.9850
|
-0.436 mmol/L
Standard Deviation 2.2337
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 40
|
-0.432 mmol/L
Standard Deviation 2.1153
|
-0.474 mmol/L
Standard Deviation 1.6397
|
-0.512 mmol/L
Standard Deviation 2.1578
|
-0.882 mmol/L
Standard Deviation 1.9812
|
-0.950 mmol/L
Standard Deviation 2.0248
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Sodium Week 48
|
-0.237 mmol/L
Standard Deviation 1.7772
|
-0.763 mmol/L
Standard Deviation 1.8074
|
-0.732 mmol/L
Standard Deviation 1.8845
|
-0.706 mmol/L
Standard Deviation 1.5281
|
-0.750 mmol/L
Standard Deviation 2.1334
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Urea nitrogen was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 1
|
-0.093 mmol/L
Standard Deviation 1.0815
|
0.126 mmol/L
Standard Deviation 1.2116
|
-0.123 mmol/L
Standard Deviation 1.0989
|
-0.012 mmol/L
Standard Deviation 1.0900
|
0.173 mmol/L
Standard Deviation 1.5513
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 8
|
0.007 mmol/L
Standard Deviation 0.9936
|
0.023 mmol/L
Standard Deviation 1.1685
|
-0.070 mmol/L
Standard Deviation 1.1143
|
-0.379 mmol/L
Standard Deviation 1.2316
|
0.080 mmol/L
Standard Deviation 1.1265
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 20
|
-0.207 mmol/L
Standard Deviation 1.2670
|
-0.490 mmol/L
Standard Deviation 1.0901
|
-0.064 mmol/L
Standard Deviation 1.2916
|
-0.357 mmol/L
Standard Deviation 1.1572
|
-0.035 mmol/L
Standard Deviation 1.3202
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 24
|
-0.256 mmol/L
Standard Deviation 1.1378
|
-0.523 mmol/L
Standard Deviation 1.1235
|
-0.232 mmol/L
Standard Deviation 1.4951
|
-0.289 mmol/L
Standard Deviation 1.1369
|
-0.138 mmol/L
Standard Deviation 1.2245
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 44
|
-0.105 mmol/L
Standard Deviation 1.3389
|
-0.047 mmol/L
Standard Deviation 1.3456
|
-0.054 mmol/L
Standard Deviation 1.1276
|
-0.229 mmol/L
Standard Deviation 1.1979
|
0.210 mmol/L
Standard Deviation 1.2264
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 2
|
0.386 mmol/L
Standard Deviation 1.8183
|
-0.208 mmol/L
Standard Deviation 1.1329
|
-0.047 mmol/L
Standard Deviation 1.0359
|
0.024 mmol/L
Standard Deviation 1.1762
|
0.212 mmol/L
Standard Deviation 1.3064
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 4
|
0.027 mmol/L
Standard Deviation 1.3217
|
0.013 mmol/L
Standard Deviation 1.1307
|
0.083 mmol/L
Standard Deviation 1.1244
|
-0.224 mmol/L
Standard Deviation 1.1449
|
0.007 mmol/L
Standard Deviation 1.2384
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 12
|
-0.166 mmol/L
Standard Deviation 1.2654
|
-0.244 mmol/L
Standard Deviation 1.1740
|
-0.231 mmol/L
Standard Deviation 1.3357
|
-0.429 mmol/L
Standard Deviation 1.1733
|
-0.151 mmol/L
Standard Deviation 1.2426
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 16
|
-0.133 mmol/L
Standard Deviation 1.0656
|
-0.087 mmol/L
Standard Deviation 0.9793
|
-0.200 mmol/L
Standard Deviation 1.3083
|
-0.218 mmol/L
Standard Deviation 1.0747
|
0.012 mmol/L
Standard Deviation 1.1996
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 28
|
-0.267 mmol/L
Standard Deviation 1.3487
|
-0.287 mmol/L
Standard Deviation 1.0992
|
0.012 mmol/L
Standard Deviation 1.3020
|
-0.263 mmol/L
Standard Deviation 1.1835
|
-0.082 mmol/L
Standard Deviation 1.3239
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 32
|
-0.097 mmol/L
Standard Deviation 1.0396
|
-0.141 mmol/L
Standard Deviation 1.3098
|
-0.200 mmol/L
Standard Deviation 1.1266
|
-0.326 mmol/L
Standard Deviation 1.1199
|
0.082 mmol/L
Standard Deviation 1.1841
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 36
|
-0.203 mmol/L
Standard Deviation 1.0579
|
-0.308 mmol/L
Standard Deviation 1.1757
|
0.015 mmol/L
Standard Deviation 1.1094
|
-0.247 mmol/L
Standard Deviation 1.1683
|
-0.018 mmol/L
Standard Deviation 1.1014
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 40
|
-0.214 mmol/L
Standard Deviation 1.2537
|
0.192 mmol/L
Standard Deviation 1.3690
|
0.068 mmol/L
Standard Deviation 1.1230
|
-0.132 mmol/L
Standard Deviation 1.1834
|
0.283 mmol/L
Standard Deviation 1.3435
|
|
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Week 48
|
-0.111 mmol/L
Standard Deviation 1.4431
|
-0.113 mmol/L
Standard Deviation 1.1796
|
-0.222 mmol/L
Standard Deviation 1.4085
|
-0.285 mmol/L
Standard Deviation 1.2611
|
0.088 mmol/L
Standard Deviation 1.4580
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study.
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
Outcome measures
| Measure |
Placebo (FAS)
n=2 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=6 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=5 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=7 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=4 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 8
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.8165
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 1.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 16
|
-55.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.800 cells/HPF
Standard Deviation 1.7889
|
0.500 cells/HPF
Standard Deviation 1.7321
|
0.000 cells/HPF
Standard Deviation 0.0000
|
2.500 cells/HPF
Standard Deviation 3.5355
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 32
|
-27.500 cells/HPF
Standard Deviation 38.8909
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
2.000 cells/HPF
Standard Deviation 3.4641
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 36
|
-55.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-1.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 28
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 32
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 16
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-0.200 cells/HPF
Standard Deviation 1.7889
|
33.750 cells/HPF
Standard Deviation 67.5000
|
-0.400 cells/HPF
Standard Deviation 0.8944
|
0.500 cells/HPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 20
|
0.000 cells/HPF
Standard Deviation 2.8284
|
3.000 cells/HPF
Standard Deviation 6.0000
|
57.800 cells/HPF
Standard Deviation 145.4036
|
0.667 cells/HPF
Standard Deviation 1.5055
|
-6.750 cells/HPF
Standard Deviation 14.8633
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 24
|
—
|
2.750 cells/HPF
Standard Deviation 4.8563
|
-6.500 cells/HPF
Standard Deviation 13.0000
|
2.286 cells/HPF
Standard Deviation 4.8206
|
0.333 cells/HPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 40
|
—
|
-0.500 cells/HPF
Standard Deviation 2.5166
|
-7.500 cells/HPF
Standard Deviation 15.0000
|
1.500 cells/HPF
Standard Deviation 3.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 44
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.400 cells/HPF
Standard Deviation 0.8944
|
-1.400 cells/HPF
Standard Deviation 3.1305
|
-0.500 cells/HPF
Standard Deviation 1.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 48
|
0.000 cells/HPF
Standard Deviation 0.0000
|
8.000 cells/HPF
Standard Deviation 21.6148
|
69.500 cells/HPF
Standard Deviation 139.0000
|
-1.000 cells/HPF
Standard Deviation 1.7321
|
0.250 cells/HPF
Standard Deviation 0.5000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 1
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 2
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 4
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 8
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 12
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 16
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 24
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 28
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 32
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 36
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.167 cells/HPF
Standard Deviation 0.4082
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 40
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 44
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 48
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 1
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.250 cells/HPF
Standard Deviation 1.2583
|
3.000 cells/HPF
Standard Deviation 5.1962
|
-0.200 cells/HPF
Standard Deviation 0.4472
|
-0.333 cells/HPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 2
|
1.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-8.000 cells/HPF
Standard Deviation 14.6969
|
-0.250 cells/HPF
Standard Deviation 3.6856
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-1.667 cells/HPF
Standard Deviation 1.5275
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 4
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-1.800 cells/HPF
Standard Deviation 7.1554
|
0.000 cells/HPF
Standard Deviation 0.0000
|
1.000 cells/HPF
Standard Deviation 1.4142
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 8
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.500 cells/HPF
Standard Deviation 1.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.333 cells/HPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 16
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-2.750 cells/HPF
Standard Deviation 5.5000
|
-0.200 cells/HPF
Standard Deviation 0.4472
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 20
|
1.000 cells/HPF
Standard Deviation 1.4142
|
-2.750 cells/HPF
Standard Deviation 5.5000
|
-1.400 cells/HPF
Standard Deviation 5.6391
|
-0.167 cells/HPF
Standard Deviation 0.9832
|
-0.750 cells/HPF
Standard Deviation 0.9574
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 24
|
—
|
1.000 cells/HPF
Standard Deviation 1.4142
|
1.000 cells/HPF
Standard Deviation 2.0000
|
-0.286 cells/HPF
Standard Deviation 0.4880
|
1.333 cells/HPF
Standard Deviation 4.1633
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 28
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-3.000 cells/HPF
Standard Deviation 6.0000
|
0.600 cells/HPF
Standard Deviation 1.3416
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
-1.667 cells/HPF
Standard Deviation 1.5275
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 32
|
0.500 cells/HPF
Standard Deviation 0.7071
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.500 cells/HPF
Standard Deviation 1.0000
|
-0.667 cells/HPF
Standard Deviation 0.8165
|
-0.500 cells/HPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 36
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 40
|
—
|
-2.750 cells/HPF
Standard Deviation 5.5000
|
0.750 cells/HPF
Standard Deviation 1.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-0.500 cells/HPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 44
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-1.000 cells/HPF
Standard Deviation 2.2361
|
0.600 cells/HPF
Standard Deviation 1.3416
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
-0.500 cells/HPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 48
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.667 cells/HPF
Standard Deviation 1.6330
|
1.250 cells/HPF
Standard Deviation 1.8930
|
0.333 cells/HPF
Standard Deviation 0.5774
|
-1.000 cells/HPF
Standard Deviation 1.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 1
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 2
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 4
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 8
|
—
|
1.000 cells/HPF
Standard Deviation 1.7321
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 12
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.200 cells/HPF
Standard Deviation 0.4472
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 16
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.400 cells/HPF
Standard Deviation 0.8944
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 20
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 24
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 36
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.167 cells/HPF
Standard Deviation 0.4082
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 40
|
—
|
0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 44
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Transitional Epithelial Cells Week 48
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 1
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
2.750 cells/HPF
Standard Deviation 6.1847
|
-7.667 cells/HPF
Standard Deviation 13.2791
|
-0.200 cells/HPF
Standard Deviation 1.0954
|
0.667 cells/HPF
Standard Deviation 1.1547
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 2
|
2.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-2.500 cells/HPF
Standard Deviation 2.0817
|
-3.000 cells/HPF
Standard Deviation 6.6833
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 4
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-4.600 cells/HPF
Standard Deviation 10.2372
|
0.250 cells/HPF
Standard Deviation 0.5000
|
2.000 cells/HPF
Standard Deviation 2.8284
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 8
|
—
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-1.500 cells/HPF
Standard Deviation 3.6968
|
0.000 cells/HPF
Standard Deviation 0.0000
|
4.000 cells/HPF
Standard Deviation 6.9282
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 44
|
-55.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.400 cells/HPF
Standard Deviation 0.8944
|
-0.250 cells/HPF
Standard Deviation 1.2583
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 48
|
-27.500 cells/HPF
Standard Deviation 38.8909
|
0.167 cells/HPF
Standard Deviation 0.4082
|
1.750 cells/HPF
Standard Deviation 3.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.8165
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 1
|
-55.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.750 cells/HPF
Standard Deviation 0.9574
|
0.333 cells/HPF
Standard Deviation 0.5774
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.333 cells/HPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 2
|
-54.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-0.500 cells/HPF
Standard Deviation 0.5774
|
0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
1.333 cells/HPF
Standard Deviation 2.5166
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 4
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
3.333 cells/HPF
Standard Deviation 5.7735
|
0.000 cells/HPF
Standard Deviation 0.7071
|
0.250 cells/HPF
Standard Deviation 0.5000
|
-0.500 cells/HPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 12
|
-23.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.800 cells/HPF
Standard Deviation 1.3038
|
0.000 cells/HPF
Standard Deviation 0.0000
|
-0.333 cells/HPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 20
|
-30.000 cells/HPF
Standard Deviation 35.3553
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.400 cells/HPF
Standard Deviation 1.1402
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.250 cells/HPF
Standard Deviation 0.5000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 24
|
—
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
0.250 cells/HPF
Standard Deviation 0.5000
|
-0.143 cells/HPF
Standard Deviation 0.8997
|
1.000 cells/HPF
Standard Deviation 2.6458
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 28
|
-5.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation 0.8165
|
0.400 cells/HPF
Standard Deviation 1.5166
|
0.000 cells/HPF
Standard Deviation 0.0000
|
2.333 cells/HPF
Standard Deviation 5.7735
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes Week 40
|
—
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
0.750 cells/HPF
Standard Deviation 1.5000
|
-0.250 cells/HPF
Standard Deviation 0.5000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 12
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
1.667 cells/HPF
Standard Deviation 4.7258
|
13.500 cells/HPF
Standard Deviation 26.3376
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 28
|
-2.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-0.750 cells/HPF
Standard Deviation 0.9574
|
-5.400 cells/HPF
Standard Deviation 12.0748
|
0.000 cells/HPF
Standard Deviation 0.0000
|
2.333 cells/HPF
Standard Deviation 4.0415
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 32
|
0.000 cells/HPF
Standard Deviation 0.0000
|
3.333 cells/HPF
Standard Deviation 5.7735
|
-6.500 cells/HPF
Standard Deviation 13.0000
|
-1.333 cells/HPF
Standard Deviation 1.6330
|
1.333 cells/HPF
Standard Deviation 2.3094
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Leukocytes Week 36
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.667 cells/HPF
Standard Deviation 2.7325
|
0.000 cells/HPF
Standard Deviation 0.0000
|
24.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Renal Epithelial Casts Week 20
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.000 cells/HPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Squamous Epithelial Cells Week 12
|
0.000 cells/HPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
-4.333 cells/HPF
Standard Deviation 7.5056
|
-2.200 cells/HPF
Standard Deviation 5.4955
|
0.000 cells/HPF
Standard Deviation 0.0000
|
0.333 cells/HPF
Standard Deviation 0.5774
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study.
Hyaline casts was measured in cells per low power field (cells/LPF).
Outcome measures
| Measure |
Placebo (FAS)
n=2 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=6 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=5 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=7 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=4 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 1
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
1.000 cells/LPF
Standard Deviation 1.7321
|
-0.200 cells/LPF
Standard Deviation 0.4472
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 2
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.250 cells/LPF
Standard Deviation 0.5000
|
1.000 cells/LPF
Standard Deviation 1.1547
|
-0.250 cells/LPF
Standard Deviation 0.5000
|
0.333 cells/LPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 4
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.800 cells/LPF
Standard Deviation 1.0954
|
-0.250 cells/LPF
Standard Deviation 0.5000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 8
|
—
|
0.333 cells/LPF
Standard Deviation 0.5774
|
0.250 cells/LPF
Standard Deviation 0.5000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 12
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
5.000 cells/LPF
Standard Deviation 11.1803
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 16
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.500 cells/LPF
Standard Deviation 1.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.500 cells/LPF
Standard Deviation 0.7071
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 20
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.600 cells/LPF
Standard Deviation 0.8944
|
1.500 cells/LPF
Standard Deviation 3.6742
|
-0.750 cells/LPF
Standard Deviation 1.5000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 24
|
—
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.250 cells/LPF
Standard Deviation 0.5000
|
0.857 cells/LPF
Standard Deviation 2.2678
|
0.333 cells/LPF
Standard Deviation 0.5774
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 28
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.400 cells/LPF
Standard Deviation 0.8944
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 32
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
1.250 cells/LPF
Standard Deviation 2.5000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
13.333 cells/LPF
Standard Deviation 23.0940
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 36
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 48
|
0.000 cells/LPF
Standard Deviation 0.0000
|
1.167 cells/LPF
Standard Deviation 2.8577
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.250 cells/LPF
Standard Deviation 0.5000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 40
|
—
|
0.000 cells/LPF
Standard Deviation 0.0000
|
-0.500 cells/LPF
Standard Deviation 1.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
|
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Week 44
|
0.000 cells/LPF
Standard Deviation NA
Value was not evaluable because only one participant was analyzed.
|
0.400 cells/LPF
Standard Deviation 0.8944
|
-0.400 cells/LPF
Standard Deviation 0.8944
|
0.000 cells/LPF
Standard Deviation 0.0000
|
0.000 cells/LPF
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Urine pH was measured on a pH scale.
Outcome measures
| Measure |
Placebo (FAS)
n=42 Participants
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=39 Participants
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=43 Participants
Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg LD (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=41 Participants
Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 1
|
-0.138 pH
Standard Deviation 0.9198
|
0.197 pH
Standard Deviation 0.5875
|
0.023 pH
Standard Deviation 0.8014
|
0.085 pH
Standard Deviation 0.6011
|
0.000 pH
Standard Deviation 0.8321
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 2
|
-0.155 pH
Standard Deviation 0.9072
|
0.154 pH
Standard Deviation 0.7708
|
-0.081 pH
Standard Deviation 0.7149
|
0.134 pH
Standard Deviation 0.8293
|
-0.012 pH
Standard Deviation 0.7541
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 4
|
-0.195 pH
Standard Deviation 0.9211
|
0.026 pH
Standard Deviation 0.6571
|
-0.134 pH
Standard Deviation 0.8368
|
0.063 pH
Standard Deviation 0.6620
|
-0.098 pH
Standard Deviation 0.6729
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 8
|
0.000 pH
Standard Deviation 0.7826
|
0.077 pH
Standard Deviation 0.7393
|
-0.024 pH
Standard Deviation 0.8762
|
0.263 pH
Standard Deviation 0.7235
|
0.024 pH
Standard Deviation 0.7579
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 12
|
-0.100 pH
Standard Deviation 1.0203
|
0.237 pH
Standard Deviation 0.7600
|
-0.047 pH
Standard Deviation 0.6971
|
0.211 pH
Standard Deviation 0.6641
|
0.073 pH
Standard Deviation 0.8843
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 16
|
-0.107 pH
Standard Deviation 0.8449
|
0.092 pH
Standard Deviation 0.7957
|
-0.122 pH
Standard Deviation 0.8199
|
0.118 pH
Standard Deviation 0.7207
|
0.088 pH
Standard Deviation 0.7240
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 20
|
-0.113 pH
Standard Deviation 0.7884
|
0.269 pH
Standard Deviation 0.8649
|
-0.012 pH
Standard Deviation 0.8300
|
-0.054 pH
Standard Deviation 0.6539
|
0.063 pH
Standard Deviation 0.8929
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 36
|
-0.211 pH
Standard Deviation 0.8353
|
0.118 pH
Standard Deviation 0.7300
|
-0.195 pH
Standard Deviation 0.8506
|
-0.118 pH
Standard Deviation 0.6038
|
-0.077 pH
Standard Deviation 0.7569
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 40
|
-0.216 pH
Standard Deviation 0.9394
|
-0.041 pH
Standard Deviation 0.6388
|
-0.188 pH
Standard Deviation 0.8525
|
-0.191 pH
Standard Deviation 0.5643
|
-0.154 pH
Standard Deviation 0.7448
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 44
|
-0.458 pH
Standard Deviation 0.7780
|
-0.171 pH
Standard Deviation 0.7002
|
-0.159 pH
Standard Deviation 0.9044
|
-0.167 pH
Standard Deviation 0.6693
|
-0.171 pH
Standard Deviation 0.7285
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 48
|
-0.092 pH
Standard Deviation 1.0771
|
-0.014 pH
Standard Deviation 0.7318
|
-0.200 pH
Standard Deviation 0.8533
|
-0.015 pH
Standard Deviation 0.7855
|
-0.100 pH
Standard Deviation 0.7528
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 24
|
-0.154 pH
Standard Deviation 0.9400
|
-0.013 pH
Standard Deviation 0.8011
|
-0.085 pH
Standard Deviation 0.6605
|
0.100 pH
Standard Deviation 0.4820
|
-0.026 pH
Standard Deviation 0.6973
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 28
|
-0.090 pH
Standard Deviation 0.8419
|
-0.053 pH
Standard Deviation 0.6657
|
-0.122 pH
Standard Deviation 0.7313
|
0.086 pH
Standard Deviation 0.6122
|
-0.088 pH
Standard Deviation 0.6783
|
|
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Week 32
|
-0.218 pH
Standard Deviation 0.8335
|
-0.079 pH
Standard Deviation 0.7491
|
0.063 pH
Standard Deviation 0.8784
|
-0.103 pH
Standard Deviation 0.6717
|
-0.269 pH
Standard Deviation 0.5718
|
Adverse Events
Placebo (SS) - up to Wk 12
BKZ 16 mg (SS) - up to Wk 12
BKZ 160 mg & 160 mg LD (SS) - up to Wk 68
BKZ 320 mg (SS) - up to Wk 68
Serious adverse events
| Measure |
Placebo (SS) - up to Wk 12
n=42 participants at risk
This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
|
BKZ 16 mg (SS) - up to Wk 12
n=39 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 160 mg & 160 mg LD (SS) - up to Wk 68
n=126 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
|
BKZ 320 mg (SS) - up to Wk 68
n=80 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/126 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Endocrine disorders
Goitre
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
Other adverse events
| Measure |
Placebo (SS) - up to Wk 12
n=42 participants at risk
This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
|
BKZ 16 mg (SS) - up to Wk 12
n=39 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 160 mg & 160 mg LD (SS) - up to Wk 68
n=126 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
|
BKZ 320 mg (SS) - up to Wk 68
n=80 participants at risk
This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
|
|---|---|---|---|---|
|
Infections and infestations
Ear infection
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.1%
2/39 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.79%
1/126 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/80 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.1%
2/39 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
6.3%
8/126 • Number of events 8 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
2.5%
2/80 • Number of events 3 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/42 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.6%
7/126 • Number of events 8 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
3.8%
3/80 • Number of events 3 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
7.7%
3/39 • Number of events 3 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
9.5%
12/126 • Number of events 15 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
13.8%
11/80 • Number of events 11 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
3.2%
4/126 • Number of events 4 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
8.8%
7/80 • Number of events 7 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
2.6%
1/39 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
9.5%
12/126 • Number of events 12 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
10.0%
8/80 • Number of events 10 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
7.1%
3/42 • Number of events 4 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.1%
2/39 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
1.6%
2/126 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
1.2%
1/80 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.1%
2/39 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/126 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
3.8%
3/80 • Number of events 4 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/42 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
5.1%
2/39 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/126 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
1.2%
1/80 • Number of events 1 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
|
Vascular disorders
Hypertension
|
9.5%
4/42 • Number of events 4 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/39 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
0.00%
0/126 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
|
2.5%
2/80 • Number of events 2 • Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68)
At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment. 160mg LD is considered 160mg.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60