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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 (BE ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02969525
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Other: Placebo
Drug: Bimekizumab
Enrollment 206
Recruitment Details The study started to enroll patients in October 2016 and concluded in July 2018.
Pre-assignment Details

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.

Arm/Group Title Placebo BKZ 16 mg BKZ 160 mg BKZ 160 mg LD BKZ 320 mg Placebo - BKZ 160 mg Placebo - BZK 320 mg BKZ 16 mg - BKZ 160 mg BZK 16 mg - BZK 320 mg BZK 160 mg LD - BZK 160 mg BZK 160 mg - BKZ Dose 160 mg BKZ 320 mg - BKZ 320 mg
Hide Arm/Group Description Participants received Placebo during the 12 Weeks Double-Blind Period. Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. 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. Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Double-Blind Period
Started 42 41 41 41 41 0 0 0 0 0 0 0
Completed Double-Blind Period 42 41 40 39 41 0 0 0 0 0 0 0
Completed Wk12 and Started Dose-Blind 40 41 40 37 41 0 0 0 0 0 0 0
Completed 40 41 40 37 41 0 0 0 0 0 0 0
Not Completed 2 0 1 4 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             1             1             0             0             0             0             0             0             0             0
LOW EGFR             0             0             0             1             0             0             0             0             0             0             0             0
Study medication discontinued prior Wk12             2             0             0             2             0             0             0             0             0             0             0             0
Period Title: Dose-Blind Period
Started 0 0 0 0 0 20 20 22 19 37 40 41
Completed 0 0 0 0 0 20 18 22 18 34 38 39
Not Completed 0 0 0 0 0 0 2 0 1 3 2 2
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             1             1             1
Withdrawal by Subject             0             0             0             0             0             0             2             0             1             2             0             0
Non-cooperating patient             0             0             0             0             0             0             0             0             0             0             0             1
Withdrew before Safety Follow-up visit             0             0             0             0             0             0             0             0             0             0             1             0
Arm/Group Title Placebo BKZ 16 mg BKZ 160 mg BKZ 160 mg LD BKZ 320 mg Total Title
Hide Arm/Group Description Participants received Placebo during the 12 Weeks Double-Blind Period. Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. 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. Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. 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. [Not Specified]
Overall Number of Baseline Participants 42 41 41 41 41 206
Hide Baseline Analysis Population Description
The Baseline Characteristics refer to the Full Analysis Set (FAS), which 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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 41 participants 41 participants 206 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  90.5%
35
  85.4%
40
  97.6%
36
  87.8%
36
  87.8%
185
  89.8%
>=65 years
4
   9.5%
6
  14.6%
1
   2.4%
5
  12.2%
5
  12.2%
21
  10.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 41 participants 41 participants 41 participants 41 participants 206 participants
49.02  (12.07) 49.98  (13.56) 48.00  (11.65) 49.05  (12.99) 50.39  (12.08) 49.29  (12.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 41 participants 41 participants 206 participants
Female
18
  42.9%
17
  41.5%
21
  51.2%
27
  65.9%
18
  43.9%
101
  49.0%
Male
24
  57.1%
24
  58.5%
20
  48.8%
14
  34.1%
23
  56.1%
105
  51.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 41 participants 41 participants 206 participants
Asian
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Black
1
   2.4%
1
   2.4%
2
   4.9%
1
   2.4%
0
   0.0%
5
   2.4%
White
40
  95.2%
40
  97.6%
39
  95.1%
40
  97.6%
41
 100.0%
200
  97.1%
1.Primary Outcome
Title ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
Hide Description

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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
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).
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).
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).
Overall Number of Participants Analyzed 42 41 41 41 41
Measure Type: Number
Unit of Measure: percentage of subjects
7.1 26.8 41.5 46.3 24.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS), BKZ 160 mg (FAS), BKZ 160 mg LD (FAS), BKZ 320 mg (FAS)
Comments

Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.

The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.031
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Correlation statistic
Estimated Value 4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value =0.032
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
1.13 to 15.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value =0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
2.28 to 28.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg LD (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
2.73 to 34.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value =0.051
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
1.00 to 13.68
Estimation Comments [Not Specified]
2.Secondary Outcome
Title ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
Hide Description

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.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
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).
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).
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).
Overall Number of Participants Analyzed 42 41 41 41 41
Measure Type: Number
Unit of Measure: percentage of subjects
19.0 53.7 73.2 61.0 51.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.002
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
1.73 to 12.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.0
Confidence Interval (2-Sided) 95%
3.91 to 30.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg LD (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
2.31 to 16.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
1.59 to 11.35
Estimation Comments [Not Specified]
3.Secondary Outcome
Title ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
Hide Description

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.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
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).
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).
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).
Overall Number of Participants Analyzed 42 41 41 41 41
Measure Type: Number
Unit of Measure: percentage of subjects
4.8 12.2 19.5 31.7 14.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.279
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
0.50 to 11.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.065
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
0.92 to 17.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg LD (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.006
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
1.77 to 31.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.172
Comments No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
0.63 to 13.39
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Week 12
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Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
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).
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).
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).
Overall Number of Participants Analyzed 20 14 16 17 11
Measure Type: Number
Unit of Measure: percentage of subjects
10.0 35.7 62.5 52.9 45.5
5.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Week 12
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Hide Analysis Population Description
Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
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).
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).
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).
Overall Number of Participants Analyzed 20 14 16 17 11
Measure Type: Number
Unit of Measure: percentage of subjects
10.0 57.1 68.8 70.6 72.7
6.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During the Study
Hide Description 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.
Time Frame From Screening Period until the Safety Follow-Up Visit (up to Week 72)
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Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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).
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.
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.
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.
Overall Number of Participants Analyzed 42 39 126 80
Measure Type: Number
Unit of Measure: percentage of participants
57.1 33.33 74.6 72.5
7.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
Hide Description

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.
Time Frame From Screening Period until the Safety Follow-Up Visit (up to Week 72)
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Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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).
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.
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.
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.
Overall Number of Participants Analyzed 42 39 126 80
Measure Type: Number
Unit of Measure: percentage of participants
2.4 0 6.3 0
8.Secondary Outcome
Title Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
Hide Description 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.
Time Frame From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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).
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.
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.
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.
Overall Number of Participants Analyzed 42 39 126 80
Measure Type: Number
Unit of Measure: percentage of participants
4.8 0 4.8 2.5
9.Secondary Outcome
Title Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Hide Description Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Time Frame 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 48
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Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic Blood Pressure 30 min post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
1.3  (8.9) -1.2  (4.9) -1.2  (5.4) 0.6  (6.1) -0.6  (5.3)
Diastolic Blood Pressure 1 h post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
1.1  (8.8) -2.0  (6.3) -0.7  (8.1) 1.2  (6.7) -1.0  (5.5)
Diastolic Blood Pressure Week 1 Number Analyzed 41 participants 39 participants 43 participants 41 participants 41 participants
0.1  (9.6) -0.3  (6.5) 0.6  (11.4) -0.9  (6.6) -0.4  (6.5)
Diastolic Blood Pressure Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.7  (10.4) -0.7  (6.5) -1.0  (8.9) -2.7  (8.3) -0.1  (9.0)
Diastolic Blood Pressure Week 4 pre-dose Number Analyzed 41 participants 39 participants 42 participants 41 participants 41 participants
0.0  (8.2) -1.7  (8.4) -1.4  (10.7) -0.8  (7.8) -1.3  (7.4)
Diastolic Blood Pressure Week 4 post dose Number Analyzed 41 participants 39 participants 41 participants 40 participants 40 participants
-2.0  (8.7) -1.0  (7.3) -1.2  (8.9) -0.9  (8.3) -1.6  (7.6)
Diastolic Blood Pressure Week 8 pre-dose Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
1.0  (8.2) -1.3  (8.7) 0.3  (8.7) -0.5  (7.0) 0.2  (6.9)
Diastolic Blood Pressure Week 8 post dose Number Analyzed 41 participants 39 participants 42 participants 39 participants 41 participants
-0.9  (9.1) -1.1  (8.4) 0.6  (8.7) -0.7  (7.3) -2.2  (7.4)
Diastolic Blood Pressure Week 12 pre-dose Number Analyzed 42 participants 39 participants 42 participants 39 participants 41 participants
0.2  (9.1) -1.1  (10.4) 0.2  (8.5) -1.5  (7.9) -0.6  (8.2)
Diastolic Blood Pressure Week 12 post dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 41 participants
-0.3  (9.6) -2.0  (10.0) 0.3  (8.3) -1.8  (7.9) -2.6  (8.0)
Diastolic Blood Pressure Week 16 pre-dose Number Analyzed 42 participants 39 participants 42 participants 38 participants 41 participants
-2.7  (9.6) -3.5  (8.9) -0.8  (8.6) -1.2  (8.7) -0.4  (7.9)
Diastolic Blood Pressure Week 16 post dose Number Analyzed 40 participants 39 participants 39 participants 36 participants 39 participants
-3.0  (9.1) -1.9  (8.3) -1.7  (9.2) -1.1  (7.9) -2.4  (8.7)
Diastolic Blood Pressure Week 20 pre-dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
0.5  (10.3) -1.8  (9.0) -0.6  (8.3) -1.4  (8.3) -1.8  (7.3)
Diastolic Blood Pressure Week 20 post dose Number Analyzed 39 participants 39 participants 38 participants 36 participants 40 participants
0.1  (9.5) -3.1  (8.3) -0.4  (9.2) -3.0  (9.3) -2.6  (7.1)
Diastolic Blood Pressure Week 24 pre-dose Number Analyzed 39 participants 39 participants 41 participants 36 participants 40 participants
-0.4  (7.6) -1.6  (7.2) -0.7  (9.3) 1.0  (6.9) -1.0  (6.6)
Diastolic Blood Pressure Week 24 post dose Number Analyzed 39 participants 38 participants 38 participants 35 participants 39 participants
-0.6  (7.5) -1.7  (7.9) -0.3  (8.2) -0.3  (7.6) -1.4  (7.9)
Diastolic Blood Pressure Week 28 pre-dose Number Analyzed 39 participants 39 participants 41 participants 35 participants 40 participants
1.4  (7.9) -0.6  (9.7) 0.9  (9.5) -0.6  (6.9) -0.5  (7.5)
Diastolic Blood Pressure Week 28 post dose Number Analyzed 38 participants 39 participants 39 participants 34 participants 39 participants
1.2  (8.7) -2.0  (9.4) 1.2  (9.0) -0.2  (7.1) -1.8  (7.1)
Diastolic Blood Pressure Week 32 pre-dose Number Analyzed 39 participants 39 participants 40 participants 35 participants 39 participants
0.2  (8.5) -1.7  (8.6) 1.6  (9.2) -0.3  (9.3) -1.2  (8.6)
Diastolic Blood Pressure Week 32 post dose Number Analyzed 36 participants 39 participants 37 participants 34 participants 39 participants
0.7  (10.0) -3.0  (8.6) 0.1  (9.6) -0.6  (8.5) -2.1  (8.5)
Diastolic Blood Pressure Week 36 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
0.0  (8.6) -0.6  (9.2) 1.4  (8.9) -0.9  (7.2) 0.8  (7.5)
Diastolic Blood Pressure Week 36 post dose Number Analyzed 37 participants 38 participants 38 participants 31 participants 38 participants
1.6  (7.7) -1.6  (9.2) 1.3  (9.3) -1.7  (6.8) -0.1  (7.1)
Diastolic Blood Pressure Week 40 pre-dose Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
0.8  (7.6) -2.5  (9.7) 1.0  (9.5) -1.0  (7.2) -1.9  (6.8)
Diastolic Blood Pressure Week 40 post dose Number Analyzed 37 participants 38 participants 40 participants 33 participants 37 participants
0.9  (7.7) -1.8  (9.1) 0.2  (8.3) -0.8  (6.6) -0.1  (7.3)
Diastolic Blood Pressure Week 44 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
1.4  (9.3) -2.1  (7.7) 1.3  (9.2) -0.4  (6.7) -2.4  (10.9)
Diastolic Blood Pressure Week 44 post dose Number Analyzed 36 participants 38 participants 40 participants 33 participants 39 participants
2.3  (9.2) -1.3  (7.6) -0.7  (8.7) -1.4  (8.1) -1.5  (6.5)
Diastolic Blood Pressure Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
1.8  (9.2) 0.4  (9.7) 1.1  (9.1) 0.6  (8.7) -0.8  (6.4)
Systolic Blood Pressure 30 min post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.8  (8.1) 0.5  (9.7) -0.8  (8.2) 1.5  (8.8) -2.5  (9.7)
Systolic Blood Pressure 1 hour post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.6  (9.4) -2.0  (10.5) 0.2  (8.7) 1.0  (8.4) -1.8  (7.1)
Systolic Blood Pressure Week 1 Number Analyzed 41 participants 39 participants 43 participants 41 participants 41 participants
-1.7  (10.8) -1.3  (10.0) 1.7  (12.9) -2.4  (8.3) -1.6  (11.0)
Systolic Blood Pressure Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.7  (12.9) -0.2  (9.8) -0.1  (13.2) -2.7  (8.2) -0.4  (11.9)
Systolic Blood Pressure Week 4 pre-dose Number Analyzed 41 participants 39 participants 42 participants 41 participants 41 participants
-2.6  (11.4) -1.5  (10.6) -1.0  (13.0) -2.3  (10.5) -2.7  (11.2)
Systolic Blood Pressure Week 4 post dose Number Analyzed 41 participants 39 participants 41 participants 40 participants 40 participants
-3.5  (12.1) -0.6  (10.4) -2.2  (11.8) -0.6  (9.1) -3.7  (11.3)
Systolic Blood Pressure Week 8 pre-dose Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
-2.1  (13.1) -0.8  (10.7) -1.1  (11.3) -3.6  (11.7) -1.3  (10.4)
Systolic Blood Pressure Week 8 post dose Number Analyzed 41 participants 39 participants 42 participants 39 participants 41 participants
-3.2  (12.6) -1.9  (11.6) -0.3  (11.1) -2.8  (10.2) -1.9  (12.0)
Systolic Blood Pressure Week 12 pre-dose Number Analyzed 42 participants 39 participants 42 participants 39 participants 41 participants
-3.3  (12.4) 1.6  (13.7) -3.1  (11.7) -4.4  (10.8) -2.6  (9.7)
Systolic Blood Pressure Week 12 post dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 41 participants
-3.9  (14.1) 2.1  (11.1) -1.9  (12.0) -3.6  (10.1) -2.4  (10.1)
Systolic Blood Pressure Week 16 pre-dose Number Analyzed 42 participants 39 participants 42 participants 38 participants 41 participants
-3.6  (15.1) -2.3  (12.3) -4.3  (11.3) -4.3  (12.5) -2.3  (11.4)
Systolic Blood Pressure Week 16 post dose Number Analyzed 40 participants 39 participants 39 participants 36 participants 39 participants
-3.7  (17.1) -2.6  (11.7) -3.4  (12.7) -2.7  (11.0) -5.7  (8.5)
Systolic Blood Pressure Week 20 pre-dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
-2.0  (13.1) -3.2  (12.5) -2.6  (11.9) -5.4  (9.7) -4.5  (10.5)
Systolic Blood Pressure Week 20 post dose Number Analyzed 39 participants 39 participants 38 participants 36 participants 40 participants
-1.9  (14.5) -3.2  (13.0) -3.7  (12.2) -7.9  (11.9) -4.4  (9.9)
Systolic Blood Pressure Week 24 pre-dose Number Analyzed 39 participants 39 participants 41 participants 36 participants 40 participants
-3.1  (10.5) -1.1  (9.5) -2.7  (12.3) -3.6  (10.1) -0.3  (10.5)
Systolic Blood Pressure Week 24 post dose Number Analyzed 39 participants 38 participants 38 participants 35 participants 39 participants
-2.6  (10.9) -2.8  (10.5) -2.2  (11.7) -3.0  (9.7) -1.1  (10.5)
Systolic Blood Pressure Week 28 pre-dose Number Analyzed 39 participants 39 participants 41 participants 35 participants 40 participants
-0.1  (11.4) -2.5  (12.8) -2.5  (13.1) 0.4  (11.6) -2.9  (11.3)
Systolic Blood Pressure Week 28 post dose Number Analyzed 38 participants 39 participants 39 participants 34 participants 39 participants
-1.1  (12.1) -2.9  (11.1) -2.6  (12.4) -0.7  (11.9) -4.6  (11.2)
Systolic Blood Pressure Week 32 pre-dose Number Analyzed 39 participants 39 participants 40 participants 35 participants 39 participants
-0.9  (13.1) -1.5  (13.3) -0.6  (12.4) 0.6  (11.0) -3.7  (12.4)
Systolic Blood Pressure Week 32 post dose Number Analyzed 36 participants 39 participants 37 participants 34 participants 39 participants
-1.7  (12.6) -2.2  (11.6) 0.3  (12.5) -0.4  (11.1) -4.8  (10.6)
Systolic Blood Pressure Week 36 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
-3.1  (11.9) 1.1  (13.9) -0.2  (13.6) -1.8  (11.2) -3.2  (11.1)
Systolic Blood Pressure Week 36 post dose Number Analyzed 37 participants 38 participants 38 participants 31 participants 38 participants
-0.6  (11.1) 1.3  (12.6) -0.5  (12.4) -3.8  (10.8) -3.8  (11.4)
Systolic Blood Pressure Week 40 pre-dose Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
-3.3  (12.1) -3.1  (11.4) -1.6  (12.9) -4.0  (9.5) -1.2  (11.0)
Systolic Blood Pressure Week 40 post dose Number Analyzed 37 participants 38 participants 40 participants 33 participants 37 participants
-2.3  (11.7) -0.4  (12.7) -1.2  (13.8) -3.2  (11.6) -2.2  (9.6)
Systolic Blood Pressure Week 44 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
-2.8  (12.3) -2.8  (9.9) 0.0  (13.1) -5.1  (9.9) -3.9  (10.3)
Systolic Blood Pressure Week 44 post dose Number Analyzed 36 participants 38 participants 40 participants 33 participants 39 participants
-1.8  (14.5) -1.2  (9.5) -0.6  (10.4) -4.6  (10.3) -3.8  (10.5)
Systolic Blood Pressure Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
-1.1  (14.0) -0.1  (12.5) -0.1  (12.6) -2.8  (11.5) -5.2  (9.6)
10.Secondary Outcome
Title Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Hide Description Pulse rate was measured in beats per minute (beats/min).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: beats/min
30 min post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.4  (5.4) -0.8  (5.6) -1.5  (7.2) -2.3  (7.5) -1.1  (7.2)
1 hour post dose Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.3  (6.7) 1.0  (11.3) -0.8  (7.6) -0.8  (8.1) -0.4  (7.0)
Week 1 Number Analyzed 41 participants 39 participants 43 participants 41 participants 41 participants
2.9  (8.3) -1.5  (7.5) -0.7  (7.1) 0.6  (8.9) -0.8  (9.0)
Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
1.2  (6.4) -1.7  (5.7) -0.7  (7.9) -1.0  (9.1) -0.4  (6.9)
Week 4 pre-dose Number Analyzed 41 participants 39 participants 42 participants 41 participants 41 participants
-0.2  (5.3) -2.1  (6.9) -1.9  (8.1) 0.1  (9.8) -1.0  (6.6)
Week 4 post dose Number Analyzed 41 participants 39 participants 41 participants 40 participants 40 participants
0.4  (8.6) -2.6  (6.6) -2.7  (9.5) -0.5  (9.4) -1.1  (6.2)
Week 8 pre-dose Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
0.9  (6.5) -0.6  (8.0) -1.6  (8.6) 0.8  (6.9) -1.3  (8.2)
Week 8 post dose Number Analyzed 41 participants 39 participants 42 participants 39 participants 41 participants
-0.1  (6.9) -1.3  (8.6) -1.9  (8.6) 0.0  (8.5) -2.3  (8.3)
Week 12 pre-dose Number Analyzed 42 participants 39 participants 42 participants 39 participants 41 participants
1.1  (10.2) -2.2  (8.5) -2.9  (10.5) -1.7  (9.5) -1.1  (8.4)
Week 12 post dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 41 participants
-0.6  (8.8) -3.3  (8.8) -3.6  (9.4) -2.1  (9.7) -2.0  (7.8)
Week 16 pre-dose Number Analyzed 42 participants 39 participants 42 participants 38 participants 41 participants
-0.2  (8.5) -2.1  (5.8) -2.9  (8.0) -1.9  (10.1) -1.3  (7.2)
Week 16 post dose Number Analyzed 40 participants 39 participants 39 participants 36 participants 39 participants
-0.1  (9.9) -3.5  (5.5) -3.7  (9.7) -2.1  (9.8) -2.2  (7.3)
Week 20 pre-dose Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
-0.1  (10.3) -2.4  (7.0) -1.7  (10.3) 0.0  (9.0) -1.2  (9.0)
Week 20 post dose Number Analyzed 39 participants 39 participants 38 participants 36 participants 40 participants
-0.7  (6.8) -2.3  (7.8) -2.1  (9.7) -0.1  (8.5) -1.3  (8.9)
Week 24 pre-dose Number Analyzed 39 participants 39 participants 41 participants 36 participants 40 participants
-0.5  (7.9) -2.0  (8.1) -2.8  (10.4) -0.7  (7.3) -1.2  (7.8)
Week 24 post dose Number Analyzed 39 participants 38 participants 38 participants 35 participants 39 participants
-0.9  (7.8) -2.9  (8.5) -3.0  (9.6) -1.3  (6.9) -2.5  (7.1)
Week 28 pre-dose Number Analyzed 39 participants 39 participants 41 participants 35 participants 40 participants
1.9  (9.7) -2.1  (10.0) 0.0  (9.3) -0.5  (11.2) 0.2  (8.3)
Week 28 post dose Number Analyzed 38 participants 39 participants 39 participants 34 participants 39 participants
1.8  (7.5) -3.0  (9.4) -0.5  (8.5) -0.8  (10.0) 0.0  (7.5)
Week 32 pre-dose Number Analyzed 39 participants 39 participants 40 participants 35 participants 39 participants
3.3  (10.0) -0.9  (7.9) -2.0  (9.2) -1.2  (10.6) -0.3  (7.8)
Week 32 post dose Number Analyzed 36 participants 39 participants 37 participants 34 participants 39 participants
3.3  (8.4) -0.8  (7.8) -3.0  (9.5) -1.9  (9.6) -2.0  (8.8)
Week 36 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
0.7  (8.5) 0.2  (7.5) -2.6  (8.6) -2.6  (10.2) -0.5  (9.7)
Week 36 post dose Number Analyzed 37 participants 38 participants 38 participants 31 participants 38 participants
1.1  (7.6) -0.8  (8.2) -3.0  (9.8) -2.5  (8.2) -1.4  (9.6)
Week 40 pre-dose Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
2.7  (10.3) -0.5  (8.8) 1.0  (10.1) -1.7  (7.6) 2.0  (9.4)
Week 40 post dose Number Analyzed 37 participants 38 participants 40 participants 33 participants 37 participants
0.9  (8.3) -1.7  (8.3) 0.0  (8.9) -2.0  (8.4) 0.5  (9.1)
Week 44 pre-dose Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
2.2  (8.9) -1.6  (6.9) -0.4  (10.1) -1.4  (8.2) 0.7  (9.7)
Week 44 post dose Number Analyzed 36 participants 38 participants 40 participants 33 participants 38 participants
2.9  (6.9) -1.7  (8.0) -0.5  (11.0) -2.8  (7.7) -0.2  (10.3)
Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
2.0  (8.9) -3.7  (7.8) -2.5  (10.4) -4.2  (9.5) -3.1  (9.5)
11.Secondary Outcome
Title Changes From Baseline in Body Weight During the Study
Hide Description Body weight was measured in kilograms.
Time Frame Baseline, Week 12, Week 24, Week 36 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 41 39 43 38 41
Mean (Standard Deviation)
Unit of Measure: kilograms
Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.14  (3.38) -0.87  (3.12) 0.21  (1.78) -0.38  (1.80) -0.04  (2.39)
Week 24 Number Analyzed 39 participants 38 participants 41 participants 36 participants 40 participants
0.33  (4.10) -0.03  (3.48) -0.07  (2.63) -0.13  (2.37) -0.39  (3.73)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
0.32  (5.15) -0.14  (2.90) 0.27  (3.42) 0.15  (2.36) -0.04  (4.19)
Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
0.21  (4.42) 0.45  (3.41) 0.80  (3.84) -0.14  (3.32) 0.11  (4.24)
12.Secondary Outcome
Title Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Hide Description 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.
Time Frame Baseline, Week 12 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 40 38 42 36 41
Mean (Standard Deviation)
Unit of Measure: msec
QTcB Week 12 Number Analyzed 38 participants 36 participants 42 participants 34 participants 40 participants
3.4  (32.7) -2.8  (29.9) -5.6  (41.8) 1.5  (18.2) -1.9  (31.4)
QTcB Week 48 Number Analyzed 35 participants 37 participants 40 participants 31 participants 39 participants
-2.5  (34.8) -5.8  (36.5) -5.9  (22.2) -4.7  (21.0) -5.7  (27.7)
QTcF Week 12 Number Analyzed 37 participants 32 participants 35 participants 32 participants 39 participants
4.5  (27.5) -2.5  (22.4) -2.2  (14.2) -0.5  (17.0) -3.0  (18.8)
QTcF Week 48 Number Analyzed 35 participants 32 participants 34 participants 29 participants 38 participants
-0.1  (30.7) -6.1  (31.4) -0.2  (15.6) -2.2  (20.0) 4.6  (44.6)
PR Week 12 Number Analyzed 39 participants 37 participants 42 participants 36 participants 41 participants
-1.7  (23.3) -1.0  (23.7) -19.6  (102.1) 3.2  (18.2) -9.5  (32.3)
PR Week 48 Number Analyzed 37 participants 38 participants 40 participants 33 participants 40 participants
2.6  (33.7) 17.5  (128.8) 4.0  (163.0) 0.8  (18.9) -2.8  (26.5)
QRS Week 12 Number Analyzed 40 participants 38 participants 42 participants 36 participants 41 participants
2.6  (22.3) -2.9  (10.8) -1.8  (7.6) -0.2  (5.4) 6.1  (42.8)
QRS Week 48 Number Analyzed 38 participants 38 participants 40 participants 33 participants 40 participants
5.6  (21.4) -1.5  (16.1) -4.0  (13.0) 0.6  (16.2) 0.1  (18.7)
QT Week 12 Number Analyzed 40 participants 38 participants 42 participants 36 participants 41 participants
-2.0  (46.6) 1.7  (34.0) 9.5  (21.4) 3.8  (25.6) 11.5  (80.8)
QT Week 48 Number Analyzed 38 participants 38 participants 40 participants 33 participants 40 participants
-0.7  (33.4) 3.1  (29.9) 3.9  (22.8) 5.4  (26.7) 0.7  (31.6)
RR Week 12 Number Analyzed 39 participants 36 participants 42 participants 34 participants 41 participants
3.3  (99.3) -22.5  (212.6) 75.8  (179.3) 11.0  (125.1) -17.0  (182.1)
RR Week 48 Number Analyzed 37 participants 36 participants 40 participants 31 participants 40 participants
-0.6  (116.1) 11.9  (187.1) 65.2  (139.0) 44.3  (124.0) 25.1  (148.5)
13.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Hide Description Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: 10^9 white blood cells per liter
Basophils Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
0.000  (0.0387) 0.000  (0.0329) -0.002  (0.0408) 0.007  (0.0264) 0.008  (0.0350)
Basophils Week 2 Number Analyzed 42 participants 38 participants 43 participants 41 participants 41 participants
0.002  (0.0269) 0.003  (0.0283) 0.000  (0.0488) 0.000  (0.0316) 0.005  (0.0384)
Basophils Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
0.002  (0.0474) 0.005  (0.0324) -0.007  (0.0463) 0.005  (0.0312) 0.005  (0.0312)
Basophils Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-0.002  (0.0353) 0.000  (0.0229) -0.005  (0.0384) 0.003  (0.0367) 0.002  (0.0418)
Basophils Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.002  (0.0353) 0.003  (0.0280) -0.002  (0.0462) 0.000  (0.0329) 0.010  (0.0374)
Basophils Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
0.010  (0.0431) 0.005  (0.0324) -0.007  (0.0463) 0.000  (0.0329) 0.008  (0.0417)
Basophils Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 39 participants
-0.003  (0.0362) 0.003  (0.0362) 0.000  (0.0500) 0.005  (0.0329) 0.000  (0.0397)
Basophils Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
0.000  (0.0397) 0.005  (0.0324) -0.003  (0.0530) 0.008  (0.0368) 0.005  (0.0389)
Basophils Week 28 Number Analyzed 39 participants 38 participants 40 participants 35 participants 40 participants
0.005  (0.0394) 0.000  (0.0329) 0.008  (0.0526) 0.011  (0.0323) 0.005  (0.0450)
Basophils Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
0.000  (0.0324) 0.005  (0.0320) -0.010  (0.0441) 0.009  (0.0379) 0.010  (0.0384)
Basophils Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
0.000  (0.0408) 0.003  (0.0283) -0.002  (0.0474) 0.012  (0.0415) 0.013  (0.0409)
Basophils Week 40 Number Analyzed 36 participants 38 participants 40 participants 34 participants 38 participants
0.003  (0.0506) 0.005  (0.0399) -0.010  (0.0379) 0.006  (0.0343) 0.000  (0.0403)
Basophils Week 44 Number Analyzed 36 participants 37 participants 41 participants 34 participants 36 participants
0.006  (0.0410) 0.003  (0.0372) 0.000  (0.0387) 0.006  (0.0422) 0.000  (0.0338)
Basophils Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
-0.005  (0.0462) 0.003  (0.291) -0.010  (0.0441) 0.006  (0.0354) 0.000  (0.0324)
Eosinophils Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
0.010  (0.0860) 0.016  (0.0718) -0.002  (0.0801) -0.005  (0.0999) 0.017  (0.0636)
Eosinophils Week 2 Number Analyzed 42 participants 38 participants 43 participants 41 participants 41 participants
0.005  (0.0731) 0.013  (0.0777) 0.002  (0.0913) 0.002  (0.0880) 0.029  (0.0929)
Eosinophils Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
0.002  (0.0987) 0.016  (0.0594) 0.002  (0.0780) 0.005  (0.0999) 0.027  (0.0895)
Eosinophils Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
0.024  (0.0969) -0.003  (0.0707) 0.000  (0.1000) 0.008  (0.0941) 0.005  (0.0669)
Eosinophils Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.020  (0.0954) 0.010  (0.0882) 0.002  (0.0831) -0.026  (0.1155) 0.017  (0.0704)
Eosinophils Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
0.045  (0.1253) 0.021  (0.0935) 0.010  (0.0759) -0.005  (0.1559) 0.033  (0.0829)
Eosinophils Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 39 participants
0.036  (0.1038) 0.026  (0.1186) 0.024  (0.1157) -0.014  (0.1228) 0.038  (0.0935)
Eosinophils Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
0.031  (0.1301) 0.013  (0.0844) 0.058  (0.2111) -0.019  (0.1238) 0.037  (0.1192)
Eosinophils Week 28 Number Analyzed 39 participants 38 participants 40 participants 35 participants 40 participants
0.036  (0.0986) 0.018  (0.0926) 0.053  (0.1826) -0.000  (0.1213) 0.025  (0.0870)
Eosinophils Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
0.049  (0.1502) 0.033  (0.0838) 0.020  (0.1418) 0.024  (0.1577) 0.041  (0.1141)
Eosinophils Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
0.054  (0.1726) 0.018  (0.0955) 0.022  (0.0909) 0.027  (0.1526) 0.015  (0.0961)
Eosinophils Week 40 Number Analyzed 36 participants 38 participants 40 participants 34 participants 38 participants
0.050  (0.1444) 0.018  (0.0865) 0.018  (0.0958) 0.015  (0.1971) 0.039  (0.1128)
Eosinophils Week 44 Number Analyzed 36 participants 37 participants 41 participants 34 participants 36 participants
0.072  (0.1523) 0.019  (0.0908) 0.024  (0.0994) -0.009  (0.1798) 0.006  (0.0893)
Eosinophils Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
0.045  (0.1811) 0.006  (0.0754) 0.023  (0.0891) 0.009  (0.2833) -0.005  (0.0857)
Leukocytes Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.271  (1.1885) -0.597  (1.1490) -0.656  (1.2593) -1.029  (1.6496) -0.285  (1.6896)
Leukocytes Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.157  (1.3195) -0.131  (2.1769) -0.309  (1.3735) -0.954  (2.0441) -0.322  (1.5501)
Leukocytes Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-0.049  (1.1938) -0.411  (1.1988) -0.336  (1.5088) -1.017  (1.9397) -0.656  (1.4264)
Leukocytes Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
0.429  (1.7036) -0.333  (1.4014) -0.185  (1.2889) -1.071  (1.9639) -0.629  (1.5489)
Leukocytes Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.190  (1.6223) -0.438  (1.3854) -0.495  (1.6904) -0.997  (2.1806) -0.634  (1.6084)
Leukocytes Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-0.400  (1.5616) -0.839  (1.8179) -0.590  (1.4668) -1.318  (2.3324) -0.293  (1.8427)
Leukocytes Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 40 participants
-0.936  (1.2756) -1.100  (1.5599) -0.432  (1.3032) -0.932  (2.2832) -0.455  (1.7116)
Leukocytes Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-1.251  (1.3888) -0.884  (1.7768) -0.495  (1.4216) -1.119  (2.2807) -0.765  (1.8691)
Leukocytes Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.700  (1.8180) -0.316  (2.3086) -0.100  (1.4942) -0.894  (1.7119) -0.342  (1.5683)
Leukocytes Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.762  (1.4273) -0.862  (2.0091) -0.330  (1.5750) -0.918  (2.6184) -0.505  (1.4800)
Leukocytes Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
-0.541  (1.5971) -0.974  (1.7389) -0.366  (1.4549) -1.082  (2.3389) -0.126  (2.2565)
Leukocytes Week 40 Number Analyzed 36 participants 38 participants 41 participants 34 participants 38 participants
-0.783  (1.7693) -0.826  (1.5942) -0.437  (1.7878) -1.226  (2.3856) -0.266  (1.7976)
Leukocytes Week 44 Number Analyzed 37 participants 37 participants 41 participants 34 participants 36 participants
-1.065  (1.6070) -0.978  (1.8151) -0.537  (1.5641) -1.032  (2.1585) -0.825  (1.8917)
Leukocytes Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
-0.739  (1.7774) -0.869  (1.7109) -0.473  (1.7104) -1.225  (2.5952) -0.777  (1.8593)
Lymphocytes Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.083  (0.5074) -0.024  (0.4142) 0.044  (0.5039) -0.017  (0.4189) 0.020  (0.3006)
Lymphocytes Week 2 Number Analyzed 42 participants 38 participants 43 participants 41 participants 41 participants
0.105  (0.3246) 0.026  (0.4137) 0.021  (0.6006) 0.007  (0.3643) 0.161  (0.4277)
Lymphocytes Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
0.037  (0.4386) 0.024  (0.3259) 0.010  (0.6003) -0.032  (0.3996) 0.095  (0.3263)
Lymphocytes Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
0.120  (0.3776) 0.054  (0.3783) 0.063  (0.5928) 0.053  (0.4980) 0.129  (0.3939)
Lymphocytes Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.041  (0.3647) 0.051  (0.4167) 0.000  (0.5640) -0.047  (0.3703) 0.061  (0.3301)
Lymphocytes Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
0.052  (0.5567) 0.071  (0.3571) 0.026  (0.5539) -0.029  (0.4991) 0.135  (0.4197)
Lymphocytes Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 39 participants
0.003  (0.4934) 0.008  (0.3970) 0.149  (0.4675) -0.035  (0.4566) 0.126  (0.4216)
Lymphocytes Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-0.041  (0.3905) 0.050  (0.3630) 0.048  (0.4455) -0.036  (0.3788) 0.053  (0.3974)
Lymphocytes Week 28 Number Analyzed 39 participants 38 participants 40 participants 35 participants 40 participants
0.036  (0.5869) 0.105  (0.3594) 0.210  (0.5999) 0.103  (0.5544) 0.172  (0.3776)
Lymphocytes Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.000  (0.5109) 0.103  (0.4233) 0.083  (0.6524) 0.112  (0.5056) 0.146  (0.3966)
Lymphocytes Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
0.078  (0.4894) 0.039  (0.4227) 0.134  (0.5673) 0.103  (0.5491) 0.118  (0.3810)
Lymphocytes Week 40 Number Analyzed 36 participants 38 participants 40 participants 34 participants 38 participants
0.139  (0.4871) 0.168  (0.4281) 0.120  (0.6018) 0.038  (0.4335) 0.176  (0.3709)
Lymphocytes Week 44 Number Analyzed 36 participants 37 participants 41 participants 34 participants 36 participants
-0.008  (0.5390) 0.105  (0.4136) 0.124  (0.5366) 0.115  (0.4881) 0.153  (0.4462)
Lymphocytes Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
0.066  (0.5313) 0.103  (0.3645) 0.078  (0.5041) 0.019  (0.3763) 0.072  (0.3755)
Monocytes Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
0.007  (0.2184) -0.008  (0.1477) -0.012  (0.1679) -0.088  (0.2315) -0.027  (0.1724)
Monocytes Week 2 Number Analyzed 42 participants 38 participants 43 participants 41 participants 41 participants
0.076  (0.1358) -0.011  (0.1673) 0.014  (0.1897) -0.095  (0.2701) -0.010  (0.1882)
Monocytes Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
0.032  (0.1588) -0.021  (0.1473) -0.040  (0.1862) -0.066  (0.2404) -0.085  (0.1459)
Monocytes Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
0.059  (0.1910) -0.041  (0.1743) 0.005  (0.1580) -0.103  (0.2520) -0.071  (0.1834)
Monocytes Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.020  (0.1913) -0.031  (0.1608) -0.033  (0.1686) -0.105  (0.2630) -0.059  (0.1414)
Monocytes Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-0.007  (0.1629) -0.050  (0.1673) -0.024  (0.1265) -0.079  (0.2384) -0.043  (0.1752)
Monocytes Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 39 participants
-0.008  (0.1783) -0.041  (0.1534) -0.015  (0.1509) -0.081  (0.2448) -0.003  (0.1899)
Monocytes Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-0.026  (0.1292) -0.034  (0.1361) 0.003  (0.1476) -0.056  (0.2602) -0.027  (0.1921)
Monocytes Week 28 Number Analyzed 39 participants 38 participants 40 participants 35 participants 40 participants
0.026  (0.2087) 0.042  (0.1981) 0.055  (0.1724) -0.029  (0.2729) -0.012  (0.1911)
Monocytes Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
0.064  (0.2356) -0.005  (0.1731) -0.003  (0.1271) -0.035  (0.2684) 0.010  (0.1744)
Monocytes Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
0.054  (0.1626) -0.024  (0.1792) 0.032  (0.1404) -0.036  (0.2644) 0.049  (0.2327)
Monocytes Week 40 Number Analyzed 36 participants 38 participants 40 participants 34 participants 38 participants
0.053  (0.1647) 0.008  (0.1323) 0.020  (0.1636) -0.059  (0.2830) -0.018  (0.1504)
Monocytes Week 44 Number Analyzed 36 participants 37 participants 41 participants 34 participants 36 participants
0.019  (0.1939) -0.008  (0.1588) 0.044  (0.1644) -0.032  (0.2446) -0.019  (0.2202)
Monocytes Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
0.021  (0.2145) 0.000  (0.1707) -0.013  (0.1399) -0.078  (0.2511) -0.077  (0.1709)
Neutrophils Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.200  (1.0959) -0.558  (0.9627) -0.693  (1.2971) -0.934  (1.4768) -0.325  (1.5720)
Neutrophils Week 2 Number Analyzed 42 participants 38 participants 43 participants 41 participants 41 participants
-0.026  (1.1945) -0.418  (1.1627) -0.337  (1.3109) -0.880  (1.8457) -0.537  (1.3989)
Neutrophils Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-0.102  (1.0044) -0.405  (1.1246) -0.290  (1.3463) -0.924  (1.9975) -0.732  (1.4028)
Neutrophils Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
0.249  (1.5358) -0.346  (1.2640) -0.256  (1.3898) -1.021  (1.7129) -0.717  (1.4589)
Neutrophils Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
0.117  (1.5103) -0.456  (1.1227) -0.458  (1.6879) -0.832  (2.2192) -0.673  (1.3887)
Neutrophils Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-0.490  (1.6866) -0.879  (1.5752) -0.617  (1.6027) -1.203  (2.2840) -0.448  (1.6816)
Neutrophils Week 20 Number Analyzed 39 participants 39 participants 41 participants 37 participants 39 participants
-0.972  (1.2085) -1.069  (1.4219) -0.595  (1.4319) -0.827  (2.2663) -0.618  (1.5716)
Neutrophils Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-1.210  (1.4067) -0.895  (1.6288) -0.593  (1.5309) -1.011  (2.2968) -0.850  (1.6461)
Neutrophils Week 28 Number Analyzed 39 participants 38 participants 40 participants 35 participants 40 participants
-0.774  (1.8189) -0.484  (2.2620) -0.555  (1.2608) -0.949  (1.7676) -0.568  (1.3889)
Neutrophils Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.869  (1.2796) -0.969  (1.8241) -0.433  (1.7889) -1.038  (2.4800) -0.718  (1.4299)
Neutrophils Week 36 Number Analyzed 37 participants 38 participants 41 participants 33 participants 39 participants
-0.722  (1.6422) -0.992  (1.6583) -0.541  (1.5519) -1.185  (2.1881) -0.354  (2.1441)
Neutrophils Week 40 Number Analyzed 36 participants 38 participants 40 participants 34 participants 38 participants
-1.006  (1.7393) -0.992  (1.4740) -0.575  (1.9567) -1.229  (2.4065) -0.495  (1.5857)
Neutrophils Week 44 Number Analyzed 36 participants 37 participants 41 participants 34 participants 36 participants
-0.978  (1.2444) -1.086  (1.6049) -0.717  (1.6966) -1.109  (2.2673) -0.983  (1.6556)
Neutrophils Week 48 Number Analyzed 38 participants 36 participants 40 participants 32 participants 39 participants
-0.861  (1.6858) -0.939  (1.5670) -0.558  (1.7944) -1.178  (2.6503) -0.805  (1.6631)
14.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Hide Description Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: g/L
Ery. mean corpuscular HGB Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-2.293  (8.4594) 0.789  (8.9719) -1.860  (8.0551) 0.927  (9.1088) 1.200  (12.2395)
Ery. mean corpuscular HGB Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-2.310  (7.9923) 2.564  (9.8216) 0.465  (8.4778) 0.707  (8.6263) 2.854  (10.1822)
Ery. mean corpuscular HGB Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-3.927  (10.0633) 1.474  (10.5849) -2.500  (11.5045) -0.878  (9.4026) 1.756  (11.8697)
Ery. mean corpuscular HGB Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-5.195  (11.7158) -1.897  (11.3249) -3.780  (10.7576) -3.079  (10.7033) 0.610  (12.7493)
Ery. mean corpuscular HGB Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
-7.927  (14.6704) -3.179  (13.4122) -3.907  (11.5404) -2.684  (9.4099) 1.732  (13.3959)
Ery. mean corpuscular HGB Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-6.286  (12.3393) -3.000  (14.5751) -5.262  (12.1917) -1.026  (11.6816) -0.700  (16.1026)
Ery. mean corpuscular HGB Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
-5.050  (12.8102) 0.923  (11.8108) -1.902  (12.8078) 0.919  (8.7349) 0.200  (16.1725)
Ery. mean corpuscular HGB Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
1.000  (10.9232) 4.132  (10.3849) -0.625  (14.6685) 4.583  (11.3121) 4.250  (13.4064)
Ery. mean corpuscular HGB Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
2.179  (10.3285) 4.658  (9.6906) 1.707  (9.9505) 4.400  (13.7524) 6.150  (12.5382)
Ery. mean corpuscular HGB Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
6.308  (9.7796) 10.231  (9.5957) 4.850  (11.3692) 7.971  (12.3497) 10.462  (12.9855)
Ery. mean corpuscular HGB Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
5.500  (9.7779) 10.921  (10.2229) 2.732  (12.4097) 6.788  (12.2034) 9.462  (12.7998)
Ery. mean corpuscular HGB Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
3.108  (9.8736) 8.237  (12.0706) 4.976  (11.5639) 9.088  (11.5480) 9.079  (11.5393)
Ery. mean corpuscular HGB Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
6.297  (10.6975) 7.289  (12.6254) 3.415  (12.6293) 6.353  (14.3038) 9.278  (12.8076)
Ery. mean corpuscular HGB Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
5.079  (10.4916) 7.216  (9.3812) 2.122  (11.8769) 5.394  (12.9300) 8.250  (11.3448)
Hemoglobin Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-4.854  (5.6726) 0.000  (5.6569) 1.302  (5.1480) 0.512  (6.0462) -0.875  (4.8368)
Hemoglobin Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-4.810  (6.5154) -0.359  (5.2339) 0.070  (6.5915) -1.561  (6.7047) 0.317  (5.3499)
Hemoglobin Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-4.390  (7.5162) 0.895  (7.6434) 0.881  (6.4551) 0.512  (5.7189) 1.195  (5.8916)
Hemoglobin Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-4.561  (7.0995) 0.308  (7.0865) 2.195  (7.7628) 0.553  (6.8010) 1.195  (7.4439)
Hemoglobin Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
-5.220  (6.7879) 0.692  (7.7601) 2.488  (7.6512) 0.868  (7.3344) 2.488  (8.2344)
Hemoglobin Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-1.619  (6.4768) 2.579  (8.3880) 1.524  (8.7853) 1.737  (7.3547) 3.125  (7.7400)
Hemoglobin Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
-0.400  (7.3233) 2.667  (8.6764) 2.268  (6.9822) 1.892  (7.6186) 2.925  (7.7207)
Hemoglobin Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
0.564  (8.1879) 3.658  (9.0622) 4.075  (8.0714) 2.000  (6.6462) 3.425  (6.2834)
Hemoglobin Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-1.513  (8.0259) 3.342  (8.9511) 3.122  (8.6261) 0.857  (7.2645) 3.400  (8.6730)
Hemoglobin Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.282  (8.2684) 4.487  (8.3094) 4.300  (9.4032) 2.118  (7.4254) 5.615  (8.6378)
Hemoglobin Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
0.947  (9.1738) 6.053  (8.1405) 4.293  (9.5766) 3.818  (7.3334) 4.949  (8.4851)
Hemoglobin Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
1.432  (9.1090) 5.868  (8.7863) 4.317  (9.6552) 3.618  (7.8277) 4.132  (7.7987)
Hemoglobin Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
1.486  (10.1040) 5.000  (9.2998) 3.659  (9.1750) 4.912  (8.5895) 4.722  (8.5511)
Hemoglobin Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
2.474  (9.7002) 5.270  (9.1974) 3.780  (9.9210) 4.030  (9.2550) 4.725  (7.3554)
15.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Hide Description Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: picograms (pg)
Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.073  (0.4980) 0.058  (0.4624) -0.049  (0.4050) 0.073  (0.3975) -0.055  (0.4455)
Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.050  (0.3890) 0.126  (0.5149) 0.023  (0.4225) 0.066  (0.4357) 0.085  (0.4287)
Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-0.112  (0.5501) 0.089  (0.5584) 0.060  (0.5910) 0.012  (0.4691) 0.066  (0.6085)
Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-0.110  (0.6778) 0.141  (0.6801) 0.007  (0.5926) 0.034  (0.6851) 0.095  (0.7994)
Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
-0.285  (0.6770) 0.023  (0.7253) 0.091  (0.8358) -0.132  (0.8335) 0.039  (1.0454)
Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-0.233  (0.7281) 0.097  (0.8824) 0.014  (0.9236) -0.118  (0.8440) -0.067  (1.1713)
Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
-0.290  (0.8145) -0.033  (0.9172) 0.029  (0.9819) -0.035  (0.7013) 0.075  (1.0824)
Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-0.249  (1.0443) 0.108  (0.9947) -0.057  (1.1804) -0.097  (0.7284) -0.007  (1.2338)
Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.103  (1.0101) 0.029  (0.7241) -0.122  (1.1130) -0.211  (0.8277) 0.020  (1.2950)
Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
0.003  (1.2619) 0.297  (0.8561) 0.058  (1.1522) 0.026  (0.7684) 0.167  (1.2472)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
-0.082  (1.3242) 0.237  (0.8722) -0.093  (1.0792) -0.248  (0.8581) 0.118  (1.1473)
Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
-0.170  (1.3453) 0.134  (0.8960) -0.134  (1.2095) -0.147  (0.8645) 0.034  (1.0839)
Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
0.097  (1.3103) 0.129  (0.8742) -0.080  (1.1771) -0.159  (0.7480) 0.108  (1.2532)
Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
0.137  (1.4139) 0.178  (0.9369) -0.120  (1.1279) -0.030  (0.7888) 0.140  (1.2161)
16.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Hide Description Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: femtolitres (fL)
Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
0.422  (1.8855) -0.087  (1.9540) 0.386  (2.2542) -0.017  (2.1066) -0.510  (2.7686)
Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
0.450  (1.8867) -0.362  (2.1689) -0.021  (1.8767) -0.039  (2.3876) -0.549  (2.5751)
Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
0.829  (2.3409) -0.163  (2.4631) 0.945  (3.2325) 0.354  (2.8851) -0.259  (2.5328)
Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
1.163  (3.6524) 0.938  (2.9445) 1.110  (3.0283) 0.916  (3.0058) 0.090  (3.5125)
Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
1.478  (3.9560) 0.951  (3.4617) 1.367  (3.8471) 0.342  (3.1129) -0.390  (3.3907)
Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
1.107  (3.4022) 1.168  (3.7760) 1.571  (4.3326) -0.016  (3.6944) 0.048  (4.4345)
Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
0.497  (3.5197) -0.349  (2.8975) 0.649  (3.7758) -0.338  (2.5959) 0.202  (4.2993)
Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-1.033  (2.9007) -0.858  (2.1793) 0.143  (4.9985) -1.522  (3.1692) -1.195  (3.5759)
Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.910  (2.6477) -1.184  (2.3264) -0.754  (3.3662) -1.854  (3.6605) -1.638  (3.3447)
Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-1.654  (2.7565) -1.851  (2.4024) -1.075  (3.5390) -2.071  (3.7652) -2.351  (3.1052)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
-1.724  (3.1037) -2.266  (2.3516) -0.912  (3.9627) -2.558  (3.8468) -2.236  (3.2869)
Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
-1.386  (2.8575) -1.882  (3.1285) -1.698  (3.0263) -2.885  (3.1443) -2.421  (2.9445)
Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
-1.405  (3.4627) -1.632  (3.4207) -1.117  (3.4616) -2.171  (4.4367) -2.186  (3.4915)
Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
-0.942  (3.5913) -1.492  (2.5065) -0.846  (3.1243) -1.527  (3.6540) -1.788  (3.5554)
17.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Hide Description Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: 10^12 red blood cells per liter
Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.148  (0.2071) -0.008  (0.1927) 0.050  (0.1773) 0.008  (0.2109) -0.017  (0.1609)
Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.149  (0.2244) -0.029  (0.1788) -0.004  (0.2280) -0.063  (0.2236) 0.000  (0.1809)
Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-0.132  (0.2780) 0.018  (0.2535) 0.023  (0.2135) 0.013  (0.1955) 0.031  (0.2065)
Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-0.135  (0.2546) -0.011  (0.2206) 0.074  (0.2466) 0.014  (0.2190) 0.026  (0.2264)
Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
-0.131  (0.2678) 0.021  (0.2561) 0.069  (0.2419) 0.051  (0.2243) 0.075  (0.2393)
Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-0.020  (0.2375) 0.075  (0.2898) 0.047  (0.2810) 0.074  (0.2255) 0.110  (0.2533)
Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
0.036  (0.2618) 0.096  (0.2855) 0.068  (0.2089) 0.064  (0.2273) 0.081  (0.2191)
Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
0.059  (0.2639) 0.110  (0.2974) 0.142  (0.2573) 0.074  (0.2250) 0.110  (0.1931)
Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.034  (0.2453) 0.108  (0.2681) 0.122  (0.2445) 0.058  (0.2359) 0.106  (0.2567)
Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.010  (0.2461) 0.104  (0.2660) 0.133  (0.2716) 0.061  (0.2555) 0.156  (0.2714)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
0.044  (0.2524) 0.166  (0.2542) 0.156  (0.2849) 0.161  (0.2399) 0.145  (0.2377)
Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
0.079  (0.2682) 0.177  (0.2733) 0.163  (0.2736) 0.141  (0.2535) 0.129  (0.2403)
Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
0.035  (0.2645) 0.146  (0.2846) 0.133  (0.2622) 0.188  (0.2933) 0.135  (0.2128)
Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
0.061  (0.2693) 0.146  (0.2994) 0.141  (0.2747) 0.135  (0.2934) 0.129  (0.2354)
18.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Hide Description Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: volume % of red blood cells
Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-0.011  (0.0189) -0.001  (0.0211) 0.007  (0.0181) 0.000  (0.0206) -0.004  (0.0206)
Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.011  (0.0230) -0.004  (0.0204) -0.000  (0.0205) -0.006  (0.0220) -0.003  (0.0174)
Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-0.008  (0.0254) 0.001  (0.0211) 0.006  (0.0220) 0.003  (0.0190) 0.001  (0.0209)
Week 8 Number Analyzed 41 participants 39 participants 41 participants 38 participants 41 participants
-0.007  (0.0239) 0.003  (0.0244) 0.012  (0.0237) 0.005  (0.0208) 0.003  (0.0232)
Week 12 Number Analyzed 41 participants 39 participants 43 participants 38 participants 41 participants
-0.005  (0.0287) 0.007  (0.0281) 0.013  (0.0276) 0.006  (0.0219) 0.005  (0.0231)
Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
0.004  (0.0202) 0.012  (0.0259) 0.011  (0.0254) 0.006  (0.0240) 0.010  (0.0252)
Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
0.006  (0.0217) 0.007  (0.0270) 0.010  (0.0211) 0.004  (0.0241) 0.008  (0.0246)
Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
0.001  (0.0192) 0.006  (0.0253) 0.014  (0.0256) -0.000  (0.0222) 0.005  (0.0219)
Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.007  (0.0210) 0.004  (0.0248) 0.008  (0.0241) -0.003  (0.0229) 0.002  (0.0238)
Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-0.009  (0.0207) 0.000  (0.0249) 0.007  (0.0225) -0.004  (0.0196) 0.003  (0.0248)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
-0.004  (0.0222) 0.004  (0.0228) 0.009  (0.0258) 0.003  (0.0221) 0.003  (0.0234)
Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
0.000  (0.0231) 0.007  (0.0278) 0.007  (0.0246) -0.001  (0.0221) 0.000  (0.0206)
Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 36 participants
-0.003  (0.0272) 0.006  (0.0297) 0.007  (0.0239) 0.007  (0.0246) 0.002  (0.0194)
Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 40 participants
0.001  (0.0243) 0.007  (0.0257) 0.009  (0.0260) 0.005  (0.0252) 0.004  (0.0212)
19.Secondary Outcome
Title Changes From Baseline in Hematology Parameters During the Study (Platelets)
Hide Description Platelets was measured in number of platelets per liter (10^9/L).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets per liter
Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-5.073  (30.2609) -3.368  (25.9515) 3.209  (30.5883) -2.098  (24.6412) -9.325  (23.4109)
Week 2 Number Analyzed 42 participants 39 participants 42 participants 41 participants 41 participants
4.000  (27.3112) -5.179  (38.2800) -3.810  (41.8250) -15.122  (32.8414) -15.415  (31.7025)
Week 4 Number Analyzed 41 participants 38 participants 41 participants 41 participants 41 participants
-3.927  (29.6643) -6.868  (29.7487) -13.878  (43.7568) -19.415  (32.6450) -27.073  (41.9299)
Week 8 Number Analyzed 41 participants 39 participants 40 participants 38 participants 41 participants
1.561  (29.1042) -12.077  (28.9876) -5.475  (44.7718) -17.605  (29.8442) -26.195  (44.1719)
Week 12 Number Analyzed 41 participants 39 participants 42 participants 38 participants 41 participants
-2.171  (32.0795) -17.359  (35.4308) -11.286  (40.7451) -10.079  (44.8977) -23.171  (47.2995)
Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 40 participants
-18.833  (50.4844) -18.263  (37.3259) -13.952  (50.7173) -9.895  (35.3246) -25.425  (37.6556)
Week 20 Number Analyzed 40 participants 39 participants 41 participants 37 participants 40 participants
-18.625  (50.3988) -23.077  (39.6534) -10.512  (48.0755) -15.324  (28.8329) -22.725  (42.2502)
Week 24 Number Analyzed 39 participants 38 participants 40 participants 36 participants 40 participants
-19.974  (49.0196) -14.000  (37.7760) -4.600  (49.4025) -10.972  (36.8375) -22.900  (47.4092)
Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-24.256  (51.8001) -16.868  (40.6635) -7.683  (47.8155) -12.800  (30.7904) -19.600  (42.3052)
Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-22.410  (51.9553) -18.590  (41.7226) -13.575  (51.9304) -20.618  (38.8969) -23.179  (42.2018)
Week 36 Number Analyzed 38 participants 38 participants 41 participants 33 participants 39 participants
-25.000  (52.6990) -16.474  (46.8844) -14.561  (50.2106) -18.848  (40.0563) -23.846  (45.1340)
Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 38 participants
-23.432  (53.2747) -20.895  (41.4845) -14.927  (51.2652) -24.088  (33.4133) -21.789  (46.1467)
Week 44 Number Analyzed 37 participants 38 participants 39 participants 34 participants 36 participants
-22.703  (57.8383) -22.474  (41.0627) -18.051  (49.1646) -24.735  (38.4710) -31.389  (48.5306)
Week 48 Number Analyzed 38 participants 37 participants 41 participants 33 participants 39 participants
-27.395  (56.2963) -23.811  (47.1150) -24.220  (46.2458) -22.273  (37.4243) -28.974  (42.9960)
20.Secondary Outcome
Title Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Hide Description Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time Frame 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized study participants who received at least 1 dose of IMP.
Arm/Group Title Placebo (SS) BKZ 16 mg (SS) BKZ 160 mg (SS) BKZ 160 mg LD (SS) BKZ 320 mg (SS)
Hide Arm/Group Description:
Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
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 SS.
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 SS.
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 SS.
Overall Number of Participants Analyzed 42 39 43 41 41
Mean (Standard Deviation)
Unit of Measure: U/L
Alanine Aminotransferase Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-1.366  (12.7451) 2.526  (15.5211) 2.628  (42.1234) 3.122  (10.2791) 0.700  (9.5868)
Alanine Aminotransferase Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-1.714  (15.4624) 2.026  (8.9428) -1.047  (41.1223) 4.927  (20.9623) 1.171  (10.2978)
Alanine Aminotransferase Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-3.854  (15.1897) 1.553  (16.2758) -3.952  (38.9546) 22.756  (139.8531) -1.561  (10.1392)
Alanine Aminotransferase Week 8 Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
-4.707  (13.6478) -1.385  (9.4580) 5.465  (68.0764) 0.795  (11.4321) -1.659  (11.1009)
Alanine Aminotransferase Week 12 Number Analyzed 41 participants 39 participants 42 participants 38 participants 41 participants
-4.220  (15.1765) 0.359  (12.2356) -4.429  (38.1756) 1.184  (13.0692) -1.390  (8.1941)
Alanine Aminotransferase Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 41 participants
-2.048  (18.0026) 2.684  (16.3229) -4.857  (38.6211) 0.579  (12.9273) 0.829  (11.5432)
Alanine Aminotransferase Week 20 Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
0.300  (39.9482) 3.821  (13.0139) -4.881  (39.1808) -0.838  (11.1118) -1.350  (10.5479)
Alanine Aminotransferase Week 24 Number Analyzed 39 participants 38 participants 41 participants 36 participants 40 participants
-1.564  (19.4974) 2.789  (14.5475) -5.659  (39.6652) 1.528  (11.0259) -3.475  (8.6202)
Alanine Aminotransferase Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-3.385  (17.7373) 2.658  (12.8174) -3.244  (43.4688) -0.171  (8.7228) -2.775  (10.4280)
Alanine Aminotransferase Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-4.487  (16.5400) 2.385  (12.8956) -4.150  (44.0126) -2.176  (12.7742) -0.821  (11.5482)
Alanine Aminotransferase Week 36 Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
0.579  (10.5411) 0.184  (11.8660) -2.976  (42.9275) -0.471  (11.2848) -1.103  (10.6296)
Alanine Aminotransferase Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 39 participants
-0.622  (10.2506) 0.816  (12.6680) -2.780  (44.9719) -3.853  (11.1059) -1.385  (13.1061)
Alanine Aminotransferase Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 39 participants
2.649  (19.7993) 1.474  (13.1514) -3.415  (43.2966) -3.882  (12.8741) -2.692  (10.2525)
Alanine Aminotransferase Week 48 Number Analyzed 38 participants 37 participants 41 participants 34 participants 40 participants
2.605  (14.0646) 2.216  (12.8542) -4.561  (43.1926) -3.794  (13.1628) -0.575  (9.6181)
Alkaline Phosphatase Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-1.098  (6.0034) -1.342  (8.0983) -2.721  (7.2056) -3.244  (4.9989) -4.275  (7.1360)
Alkaline Phosphatase Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-1.905  (6.7960) -3.282  (7.8370) -4.349  (9.5963) -4.805  (7.8237) -3.585  (8.8430)
Alkaline Phosphatase Week 4 Number Analyzed 41 participants 39 participants 42 participants 41 participants 41 participants
-1.634  (9.0630) -1.077  (10.4236) -3.262  (9.9144) -1.439  (18.3508) -4.829  (10.9268)
Alkaline Phosphatase Week 8 Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
-2.220  (8.3711) 0.308  (12.6515) 1.233  (37.8014) -5.026  (10.2019) -3.585  (9.8336)
Alkaline Phosphatase Week 12 Number Analyzed 41 participants 39 participants 42 participants 38 participants 41 participants
-2.463  (8.8122) -0.462  (12.1066) -5.952  (11.0695) -4.947  (12.0538) -3.146  (17.2476)
Alkaline Phosphatase Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 41 participants
-8.357  (12.7276) -0.895  (13.1515) -7.238  (10.7722) -4.605  (11.6539) -1.512  (25.7722)
Alkaline Phosphatase Week 20 Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
-10.425  (14.0510) -5.410  (15.1895) -10.143  (13.0264) -7.027  (11.8544) -6.650  (14.8143)
Alkaline Phosphatase Week 24 Number Analyzed 39 participants 39 participants 41 participants 36 participants 40 participants
-12.795  (15.4752) -4.769  (13.8097) -9.463  (11.3448) -6.361  (12.7843) -7.225  (18.4231)
Alkaline Phosphatase Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-12.795  (16.9351) -5.684  (15.7259) -11.244  (12.6249) -8.314  (10.9054) -8.525  (16.8523)
Alkaline Phosphatase Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-13.667  (16.1870) -4.769  (16.1530) -10.900  (13.0026) -9.118  (12.5765) -8.385  (17.5988)
Alkaline Phosphatase Week 36 Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
-11.816  (19.2436) -6.368  (15.4735) -11.122  (12.3495) -8.059  (9.5217) -6.487  (19.2434)
Alkaline Phosphatase Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
-11.000  (16.9706) -5.658  (15.7485) -11.024  (12.9180) -10.559  (11.6987) -8.175  (17.8884)
Alkaline Phosphatase Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
-12.622  (17.6373) -6.421  (14.9099) -10.537  (13.5759) -8.647  (10.5483) -8.950  (18.3162)
Alkaline Phosphatase Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
-12.211  (19.0379) -6.500  (16.5313) -11.049  (14.4827) -7.765  (12.3290) -7.875  (20.1370)
Aspartate Aminotransferase Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-2.854  (10.3212) 1.447  (6.2155) -0.023  (27.5409) 2.244  (6.7889) 0.475  (5.2963)
Aspartate Aminotransferase Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-1.762  (10.5294) 0.487  (4.0967) -2.233  (26.3266) 3.805  (14.7635) 0.780  (6.1746)
Aspartate Aminotransferase Week 4 Number Analyzed 41 participants 38 participants 42 participants 41 participants 41 participants
-3.976  (10.6642) 1.289  (7.5584) -3.262  (25.1047) 8.927  (52.0660) -1.195  (4.2791)
Aspartate Aminotransferase Week 8 Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
-3.537  (10.5477) -0.077  (5.8687) 2.279  (34.7805) 1.410  (5.5900) 0.366  (6.1877)
Aspartate Aminotransferase Week 12 Number Analyzed 41 participants 39 participants 42 participants 38 participants 41 participants
-3.049  (12.2106) 0.436  (5.3054) -2.595  (22.5324) 1.053  (6.9006) 1.122  (6.2897)
Aspartate Aminotransferase Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 41 participants
-1.048  (12.1313) 2.974  (8.3649) -2.595  (24.3852) 1.526  (6.6688) 2.122  (6.1733)
Aspartate Aminotransferase Week 20 Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
6.375  (60.1309) 2.821  (6.6367) -1.095  (25.1317) 1.324  (7.1065) 0.500  (4.8569)
Aspartate Aminotransferase Week 24 Number Analyzed 39 participants 38 participants 41 participants 36 participants 40 participants
1.718  (23.7940) 2.237  (6.9182) -1.902  (26.1054) 2.889  (6.2554) 0.325  (4.3759)
Aspartate Aminotransferase Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-1.179  (13.4905) 2.289  (6.9512) -1.805  (27.4583) 2.229  (6.3063) 0.175  (4.1255)
Aspartate Aminotransferase Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
-1.385  (12.2895) 1.949  (6.2826) -0.575  (28.3177) 0.324  (6.2654) 2.051  (4.9997)
Aspartate Aminotransferase Week 36 Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
0.711  (7.3113) 1.026  (5.5140) -1.220  (25.5798) 1.588  (6.6017) 1.667  (6.0755)
Aspartate Aminotransferase Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 39 participants
0.946  (12.1494) 1.316  (5.5269) 0.244  (29.2701) -0.647  (6.0597) 2.462  (8.4972)
Aspartate Aminotransferase Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 39 participants
2.838  (15.4641) 2.553  (7.9175) -1.268  (28.4280) -0.588  (7.7190) 1.590  (6.9347)
Aspartate Aminotransferase Week 48 Number Analyzed 38 participants 37 participants 41 participants 34 participants 40 participants
2.158  (9.7939) 3.459  (6.3403) -1.927  (28.3182) 0.441  (6.6796) 2.900  (6.2339)
Gamma Glutamyl Transferase Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
0.171  (5.4447) -2.737  (7.0354) -0.535  (10.8745) 0.171  (5.0245) -2.300  (6.2684)
Gamma Glutamyl Transferase Week 2 Number Analyzed 42 participants 39 participants 43 participants 41 participants 41 participants
-0.190  (5.8736) -2.026  (7.6828) -4.116  (25.7527) -0.341  (5.2517) -1.268  (7.8773)
Gamma Glutamyl Transferase Week 4 Number Analyzed 41 participants 39 participants 42 participants 41 participants 41 participants
-0.220  (7.2129) -2.641  (9.9167) -6.143  (35.5504) 1.171  (17.6265) 0.512  (16.3968)
Gamma Glutamyl Transferase Week 8 Number Analyzed 41 participants 39 participants 43 participants 39 participants 41 participants
-1.829  (5.9745) -4.410  (11.6319) 11.581  (103.8974) -1.795  (5.7454) -1.805  (9.0698)
Gamma Glutamyl Transferase Week 12 Number Analyzed 41 participants 39 participants 42 participants 38 participants 41 participants
-0.585  (5.9033) -2.154  (10.7643) -5.762  (34.8767) -0.447  (8.3785) 3.244  (21.8229)
Gamma Glutamyl Transferase Week 16 Number Analyzed 42 participants 38 participants 42 participants 38 participants 41 participants
-0.357  (9.6445) -1.842  (13.4476) -4.357  (34.0020) -0.947  (8.1868) 15.024  (77.1617)
Gamma Glutamyl Transferase Week 20 Number Analyzed 40 participants 39 participants 42 participants 37 participants 40 participants
-0.750  (9.5051) -2.769  (13.0555) -5.452  (32.1970) -1.649  (5.5137) 1.475  (22.2722)
Gamma Glutamyl Transferase Week 24 Number Analyzed 39 participants 39 participants 41 participants 36 participants 40 participants
-0.615  (12.4173) -2.769  (10.9339) -4.122  (36.6832) -2.639  (9.4360) -2.625  (10.3272)
Gamma Glutamyl Transferase Week 28 Number Analyzed 39 participants 38 participants 41 participants 35 participants 40 participants
-0.462  (11.5618) -2.132  (11.7638) -6.341  (36.7434) -2.629  (7.6354) -0.200  (11.5585)
Gamma Glutamyl Transferase Week 32 Number Analyzed 39 participants 39 participants 40 participants 34 participants 39 participants
0.359  (15.7872) -1.538  (13.2463) -7.875  (36.9103) -3.676  (8.6435) 2.795  (21.1501)
Gamma Glutamyl Transferase Week 36 Number Analyzed 38 participants 38 participants 41 participants 34 participants 39 participants
-0.026  (14.7162) -4.289  (11.4559) -8.195  (38.6899) -2.735  (7.1236) 1.410  (18.0200)
Gamma Glutamyl Transferase Week 40 Number Analyzed 37 participants 38 participants 41 participants 34 participants 40 participants
-2.568  (9.3676) -3.842  (13.9275) -9.073  (40.5792) -4.088  (7.5573) 0.925  (20.1066)
Gamma Glutamyl Transferase Week 44 Number Analyzed 37 participants 38 participants 41 participants 34 participants 39 participants
1.081  (23.2108) -1.289  (21.3730) -7.488  (34.4145) -3.824  (7.0430) -0.949  (11.5643)
Gamma Glutamyl Transferase Week 48 Number Analyzed 38 participants 38 participants 41 participants 34 participants 40 participants
1.474  (17.6723) -2.184  (12.0850) -7.805  (35.4924) -2.941  (8.8247) 2.525  (20.6112)
Lactate Dehydrogenase Week 1 Number Analyzed 41 participants 38 participants 43 participants 41 participants 40 participants
-7.000  (16.1509) 0.026  (19.6118) -1.163  (33.1669) -0.585  (16.6673) -1.075  (18.4341)
Lactate Dehydrogenase Week 2 Number Analyzed 42 participants 39 participants