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Trial record 1 of 1 for:    NCT02905006
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Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

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: NCT02905006
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : November 19, 2020
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Parexel
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 Chronic Plaque Psoriasis
Interventions Drug: Bimekizumab
Other: Placebo
Enrollment 250
Recruitment Details The study started to enroll participants in August 2016 and concluded in July 2017.
Pre-assignment Details

The study included a 2-4 week Screening Period and a 12-week Treatment Period. Completed study was defined as completed the 12-week double-blind Treatment Period. After Treatment Period participants either enrolled in an extension study (PS0011) or entered a 20-week Safety Follow-Up Period.

Participant Flow refers to the Randomized Set.

Arm/Group Title Placebo Bimekizumab 64 mg Q4W Bimekizumab 160 mg Q4W Bimekizumab 160 mg w/ LD Q4W Bimekizumab 320 mg Q4W Bimekizumab 480 mg Q4W
Hide Arm/Group Description Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.
Period Title: Overall Study
Started 42 39 43 40 43 43
Completed Treatment Period 37 36 38 34 40 39
Enrolled in Extension Study (PS0011) 38 35 39 38 42 40
Entered Safety Follow-up Period 4 4 4 2 1 3
Completed 37 36 38 34 40 39
Not Completed 5 3 5 6 3 4
Reason Not Completed
Adverse Event             1             1             1             1             0             1
Lack of Efficacy             1             0             0             0             0             0
Protocol Violation             2             0             0             0             0             0
Lost to Follow-up             0             0             0             1             1             0
Withdrawal by Subject             0             0             1             1             0             1
Screening exclusion criteria met             1             0             0             0             0             0
Lab withdrawal criterion met             0             1             2             2             2             1
Positive for Tuberculosis             0             1             0             0             0             0
Subject positive for Hep B             0             0             1             0             0             0
Patient moved abroad             0             0             0             1             0             0
Patient randomized by mistake             0             0             0             0             0             1
Arm/Group Title Placebo Bimekizumab 64 mg Q4W Bimekizumab 160 mg Q4W Bimekizumab 160 mg w/ LD Q4W Bimekizumab 320 mg Q4W Bimekizumab 480 mg Q4W Total Title
Hide Arm/Group Description Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. [Not Specified]
Overall Number of Baseline Participants 42 39 43 40 43 43 250
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set, which consisted of all participants who received at least 1 dose of the study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 43 participants 40 participants 43 participants 43 participants 250 participants
<=18 years
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.7%
3
   1.2%
Between 18 and 65 years
39
  92.9%
36
  92.3%
40
  93.0%
35
  87.5%
39
  90.7%
36
  83.7%
225
  90.0%
>=65 years
3
   7.1%
2
   5.1%
3
   7.0%
5
  12.5%
4
   9.3%
5
  11.6%
22
   8.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 39 participants 43 participants 40 participants 43 participants 43 participants 250 participants
46.7  (12.3) 44.2  (13.8) 43.4  (12.4) 46.5  (15.2) 42.6  (13.6) 42.9  (15.2) 44.3  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 43 participants 40 participants 43 participants 43 participants 250 participants
Female
17
  40.5%
19
  48.7%
11
  25.6%
11
  27.5%
15
  34.9%
14
  32.6%
87
  34.8%
Male
25
  59.5%
20
  51.3%
32
  74.4%
29
  72.5%
28
  65.1%
29
  67.4%
163
  65.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 43 participants 40 participants 43 participants 43 participants 250 participants
American Indian/Alaskan native
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
2
   0.8%
Asian
3
   7.1%
2
   5.1%
4
   9.3%
6
  15.0%
3
   7.0%
4
   9.3%
22
   8.8%
Black
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.5%
1
   2.3%
0
   0.0%
3
   1.2%
White
39
  92.9%
35
  89.7%
39
  90.7%
33
  82.5%
39
  90.7%
38
  88.4%
223
  89.2%
1.Primary Outcome
Title Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
0 46.2 67.4 75.0 79.1 72.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
Hide Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
4.8 51.3 74.4 75.0 86.0 76.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 21.43
Confidence Interval (2-Sided) 95%
4.51 to 101.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 63.21
Confidence Interval (2-Sided) 95%
12.90 to 309.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg w/ LD Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 62.35
Confidence Interval (2-Sided) 95%
12.61 to 308.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 130.35
Confidence Interval (2-Sided) 95%
24.50 to 693.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 69.40
Confidence Interval (2-Sided) 95%
14.07 to 342.40
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
Hide Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
4.8 46.2 62.8 77.5 86.0 72.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.23
Confidence Interval (2-Sided) 95%
3.79 to 87.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 39.60
Confidence Interval (2-Sided) 95%
8.19 to 191.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg w/ LD Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 77.27
Confidence Interval (2-Sided) 95%
15.19 to 392.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 141.99
Confidence Interval (2-Sided) 95%
26.26 to 767.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 58.52
Confidence Interval (2-Sided) 95%
11.89 to 288.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
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 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
0 41.0 58.1 67.5 86.0 69.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg w/ LD Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
4.8 61.5 81.4 85.0 93.0 83.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 32.65
Confidence Interval (2-Sided) 95%
6.82 to 156.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 94.51
Confidence Interval (2-Sided) 95%
18.54 to 481.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg w/ LD Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 117.66
Confidence Interval (2-Sided) 95%
22.08 to 626.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 280.76
Confidence Interval (2-Sided) 95%
44.06 to 1789.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 107.83
Confidence Interval (2-Sided) 95%
20.82 to 558.57
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) Bimekizumab 64 mg Q4W (FAS) Bimekizumab 160 mg Q4W (FAS) Bimekizumab 160 mg w/ LD Q4W (FAS) Bimekizumab 320 mg Q4W (FAS) Bimekizumab 480 mg Q4W (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
0 28.2 27.9 60.0 55.8 48.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 64 mg Q4W (FAS)
Comments The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg Q4W (FAS)
Comments The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 160 mg w/ LD Q4W (FAS)
Comments The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 320 mg Q4W (FAS)
Comments The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Bimekizumab 480 mg Q4W (FAS)
Comments The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Plasma Concentrations of Bimekizumab During the Study
Hide Description

Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL).

Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.

Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
Arm/Group Title Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
Hide Arm/Group Description:
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 39 42 40 43 43
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Baseline Number Analyzed 39 participants 42 participants 40 participants 43 participants 43 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 1 Number Analyzed 39 participants 42 participants 40 participants 43 participants 43 participants
4.4490
(3.7526 to 5.2746)
9.2481
(6.9779 to 12.2569)
20.7892
(14.9192 to 28.9688)
21.8622
(16.0624 to 29.7563)
31.8019
(23.3488 to 43.3154)
Week 2 Number Analyzed 39 participants 41 participants 39 participants 42 participants 42 participants
3.4704
(3.0167 to 3.9923)
8.6862
(7.5316 to 10.0179)
19.0428
(16.5381 to 21.9267)
19.0324
(16.8925 to 21.4434)
27.5641
(23.8485 to 31.8586)
Week 4 Number Analyzed 39 participants 41 participants 39 participants 41 participants 40 participants
2.1282
(1.8398 to 2.4617)
5.3751
(4.5233 to 6.3872)
11.2903
(9.4809 to 13.4450)
11.9194
(10.4503 to 13.5951)
17.1811
(14.7612 to 19.9977)
Week 8 Number Analyzed 38 participants 38 participants 37 participants 40 participants 40 participants
2.3069
(1.7780 to 2.9931)
7.1859
(5.3747 to 9.6075)
10.2208
(8.8561 to 11.7957)
16.3187
(13.9947 to 19.0285)
23.3285
(19.8863 to 27.3665)
Week 12 Number Analyzed 38 participants 38 participants 33 participants 40 participants 39 participants
2.3121
(1.6037 to 3.3335)
9.5278
(8.0614 to 11.2608)
10.2557
(8.6807 to 12.1165)
18.3166
(15.1652 to 22.1228)
28.0908
(23.2463 to 33.9448)
SFU Number Analyzed 4 participants 4 participants 2 participants 1 participants 3 participants
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
0.5165
(0.0032 to 84.5222)
[1]
Values were below the level of detection; Participants had no prior BKZ treatment.
[2]
Values were below the level of detection.
8.Secondary Outcome
Title Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
Hide Description

The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Time Frame From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.
Arm/Group Title All Participants (PK-PPS)
Hide Arm/Group Description:
Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 249
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/Day
0.362
(41.7%)
9.Secondary Outcome
Title Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
Hide Description

The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Time Frame From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.
Arm/Group Title All Participants (PK-PPS)
Hide Arm/Group Description:
Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 249
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
11.5
(146%)
10.Secondary Outcome
Title Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
Hide Description

The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Time Frame From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. EC50 was estimated based on all available data and cannot be derived for each treatment arm.
Arm/Group Title All Participants (PK-PPS)
Hide Arm/Group Description:
Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 249
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
0.55
(126%)
11.Secondary Outcome
Title Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Hide Description Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).
Time Frame Baseline (Week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
Arm/Group Title Placebo (PK-PPS) Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 42 39 42 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 2.5 0 0
12.Secondary Outcome
Title Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Hide Description Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
Time Frame From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
Arm/Group Title Placebo (PK-PPS) Bimekizumab 64 mg Q4W (PK-PPS) Bimekizumab 160 mg Q4W (PK-PPS) Bimekizumab 160 mg w/ LD Q4W (PK-PPS) Bimekizumab 320 mg Q4W (PK-PPS) Bimekizumab 480 mg Q4W (PK-PPS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.
Overall Number of Participants Analyzed 42 39 42 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
0 10.3 4.8 5.0 0 0
13.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 to End of Safety Follow-up (up to Week 32)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
38.1 76.9 55.8 65.0 60.5 60.5
14.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
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 to End of Safety Follow-up (up to Week 32)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Measure Type: Number
Unit of Measure: percentage of participants
Mild 11.9 43.6 27.9 22.5 39.5 44.2
Moderate 26.2 30.8 27.9 40.0 20.9 11.6
Severe 0 2.6 0 2.5 0 4.7
15.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Hide Description Platelets was measured in number of platelets per liter (10^9/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets per liter
Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
12.1  (34.7) 3.2  (21.0) -4.6  (30.8) -14.0  (30.8) 3.5  (25.2) -0.1  (35.0)
Week 2 Number Analyzed 41 participants 39 participants 40 participants 39 participants 41 participants 41 participants
6.4  (37.8) -8.6  (26.8) -5.6  (36.4) -8.9  (27.8) 7.8  (31.2) -3.9  (41.8)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 40 participants 40 participants
-0.1  (32.0) -5.8  (28.3) -8.6  (40.1) -11.4  (21.8) -7.0  (28.9) -7.5  (36.8)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 39 participants 40 participants
5.6  (47.5) -5.2  (26.3) -13.6  (34.3) -5.6  (30.3) -0.3  (44.0) -7.6  (37.3)
Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
6.9  (37.6) -2.3  (44.7) -6.1  (43.7) 6.3  (35.6) 0.7  (39.5) -4.7  (36.4)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
2.8  (36.7) -6.0  (36.2) -13.2  (40.1) -3.6  (37.5) -5.4  (36.1) -5.5  (38.8)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
14.8  (33.3) -30.3  (71.6) 7.8  (20.0) -33.0  (31.1) 39.0 [1]   (NA) 39.3  (27.4)
[1]
Value was not evaluable because only one participant was analyzed.
16.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (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 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: g/L
Ery. mean corpuscular HGB Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
0.1  (8.1) -2.0  (10.3) -0.3  (8.8) -1.0  (11.6) 0.5  (8.6) 0.3  (8.1)
Ery. mean corpuscular HGB Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
0.1  (7.9) 1.1  (6.6) 1.6  (9.4) -0.3  (9.8) 2.6  (7.9) 1.8  (8.8)
Ery. mean corpuscular HGB Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-0.2  (9.1) 0.2  (8.3) -0.1  (9.9) -2.9  (6.3) 0.1  (8.0) -0.4  (11.7)
Ery. mean corpuscular HGB Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-2.5  (11.0) -1.7  (8.6) -0.5  (9.4) -2.9  (7.0) -0.5  (7.8) -1.3  (8.9)
Ery. mean corpuscular HGB Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-2.2  (8.0) -1.4  (12.7) 0.3  (10.3) -2.5  (7.9) -2.1  (9.2) -2.9  (9.2)
Ery. mean corpuscular HGB Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
-6.3  (12.5) -2.2  (14.7) -1.6  (9.1) -4.5  (10.1) -2.0  (12.7) -3.6  (13.7)
Ery. mean corpuscular HGB SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-12.5  (11.0) 5.3  (26.2) -5.5  (10.6) -9.5  (7.8) -2.0 [1]   (NA) -22.0  (18.0)
Hemoglobin Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
-2.9  (7.3) 0.1  (6.1) 1.0  (6.8) -2.6  (5.2) -1.0  (7.0) -0.8  (5.0)
Hemoglobin Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-3.0  (6.7) 0.5  (5.3) 0.6  (6.0) -1.5  (7.5) -1.1  (7.0) 0.5  (6.6)
Hemoglobin Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-2.9  (8.2) 0.8  (6.1) -0.9  (6.2) -2.1  (5.9) -1.8  (8.7) -0.4  (6.3)
Hemoglobin Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-2.4  (7.8) 0.7  (6.3) -0.3  (6.6) -1.2  (4.8) -2.1  (8.4) 0.9  (6.3)
Hemoglobin Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-2.7  (8.0) 1.1  (7.6) 0.8  (7.1) -0.6  (7.5) -1.8  (8.1) 0.9  (6.5)
Hemoglobin Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
-1.8  (9.1) 3.2  (9.6) -0.1  (8.1) -1.0  (8.5) -1.2  (9.3) 0.3  (7.1)
Hemoglobin SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-4.8  (7.4) 7.8  (31.0) -6.5  (4.7) -8.5  (2.1) 6.0 [1]   (NA) -6.7  (11.0)
[1]
Value was not evaluable because only one participant was analyzed.
17.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Hide Description Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: picograms (pg)
Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
-0.09  (0.57) -0.01  (0.56) -0.10  (0.55) 0.07  (0.51) -0.09  (0.87) 0.00  (0.53)
Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.04  (0.59) 0.04  (0.54) 0.05  (0.49) 0.10  (0.78) -0.03  (0.60) 0.14  (0.54)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-0.07  (0.66) 0.10  (0.84) -0.07  (0.63) -0.01  (0.42) -0.10  (0.68) 0.04  (0.50)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.17  (0.64) -0.09  (0.84) -0.16  (0.61) -0.11  (0.47) -0.12  (0.84) -0.04  (0.60)
Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-0.19  (0.64) 0.09  (1.09) -0.16  (1.10) -0.16  (0.64) -0.26  (0.99) -0.16  (0.53)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
-0.34  (0.71) 0.09  (1.53) -0.08  (0.58) -0.14  (0.66) -0.09  (1.14) -0.16  (0.67)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.33  (0.79) 2.93  (6.66) -0.15  (0.17) -0.55  (0.78) 0.70 [1]   (NA) -0.60  (1.10)
[1]
Value was not evaluable because only one participant was analyzed.
18.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Hide Description Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: femtolitres (fL)
Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
-0.35  (1.55) 0.52  (2.29) -0.25  (1.64) 0.51  (2.63) -0.23  (2.14) -0.04  (1.37)
Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.14  (1.65) -0.16  (1.31) -0.33  (1.96) 0.31  (1.32) -0.64  (1.40) -0.05  (1.60)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-0.11  (1.60) 0.23  (1.89) -0.25  (1.81) 0.67  (1.76) -0.10  (1.64) 0.22  (2.87)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
0.20  (2.84) 0.14  (2.47) -0.29  (1.90) 0.39  (1.79) -0.02  (1.92) 0.25  (1.85)
Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
0.05  (2.11) 0.71  (2.88) -0.54  (2.57) 0.16  (2.57) -0.02  (2.29) 0.36  (2.37)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
0.76  (3.81) 0.87  (3.23) 0.17  (2.39) 0.78  (2.55) 0.47  (2.88) 0.51  (3.89)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
2.58  (5.10) 7.80  (14.07) 0.90  (2.38) 0.85  (0.35) 2.80 [1]   (NA) 4.87  (8.46)
[1]
Value was not evaluable because only one participant was analyzed.
19.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Hide Description Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: 10^12 red blood cells per liter
Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
-0.081  (0.282) 0.004  (0.213) 0.047  (0.238) -0.095  (0.184) -0.029  (0.259) -0.026  (0.178)
Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.088  (0.220) 0.010  (0.193) 0.014  (0.215) -0.060  (0.282) -0.041  (0.231) -0.001  (0.232)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-0.085  (0.274) 0.019  (0.217) -0.018  (0.193) -0.066  (0.215) -0.053  (0.281) -0.015  (0.216)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.053  (0.277) 0.038  (0.218) 0.011  (0.243) -0.019  (0.145) -0.060  (0.278) 0.035  (0.224)
Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-0.062  (0.320) 0.022  (0.245) 0.048  (0.219) 0.009  (0.224) -0.028  (0.240) 0.056  (0.238)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
-0.007  (0.314) 0.092  (0.258) 0.011  (0.271) -0.005  (0.297) -0.036  (0.297) 0.039  (0.228)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.090  (0.346) -0.135  (0.184) -0.195  (0.165) -0.215  (0.035) 0.080 [1]   (NA) -0.123  (0.491)
[1]
Value was not evaluable because only one participant was analyzed.
20.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hide Description Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: volume % of red blood cells
Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
-0.88  (2.49) 0.27  (2.07) 0.33  (2.31) -0.58  (2.14) -0.36  (2.31) -0.23  (1.62)
Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.86  (2.02) 0.00  (1.65) -0.04  (2.15) -0.42  (2.61) -0.65  (2.09) -0.02  (2.03)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
-0.81  (2.40) 0.24  (2.07) -0.26  (1.86) -0.26  (1.80) -0.48  (2.57) -0.03  (2.02)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.33  (2.46) 0.41  (1.88) -0.04  (2.18) 0.02  (1.73) -0.51  (2.59) 0.44  (1.90)
Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-0.52  (2.37) 0.55  (2.51) 0.18  (1.84) 0.14  (2.61) -0.22  (2.46) 0.67  (2.03)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 35 participants 40 participants 38 participants
0.32  (2.87) 1.25  (2.29) 0.18  (2.57) 0.30  (2.99) -0.05  (2.75) 0.59  (2.02)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.20  (1.44) 1.98  (6.92) -1.20  (1.90) -1.50  (0.14) 2.10 [1]   (NA) 1.00  (0.85)
[1]
Value was not evaluable because only one participant was analyzed.
21.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Hide Description Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: 10^9 white blood cells per liter
Basophils Week 1 Number Analyzed 42 participants 39 participants 41 participants 40 participants 43 participants 42 participants
0.01  (0.03) 0.01  (0.03) 0.00  (0.03) 0.01  (0.03) 0.00  (0.04) 0.01  (0.03)
Basophils Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.00  (0.02) 0.00  (0.04) 0.01  (0.04) 0.01  (0.04) 0.01  (0.04) 0.00  (0.03)
Basophils Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.00  (0.03) 0.00  (0.05) 0.00  (0.03) 0.01  (0.02) 0.01  (0.05) 0.00  (0.04)
Basophils Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 40 participants 40 participants
0.01  (0.03) 0.00  (0.04) 0.00  (0.04) 0.01  (0.02) 0.00  (0.04) 0.00  (0.04)
Basophils Week 8 Number Analyzed 39 participants 37 participants 37 participants 34 participants 40 participants 40 participants
0.00  (0.04) -0.01  (0.04) 0.02  (0.01) 0.00  (0.00) 0.02  (0.04) 0.00  (0.05)
Basophils Week 12 Number Analyzed 38 participants 38 participants 37 participants 34 participants 40 participants 38 participants
0.00  (0.03) 0.00  (0.04) 0.01  (0.03) 0.00  (0.02) 0.01  (0.04) 0.00  (0.04)
Basophils SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.03  (0.05) -0.03  (0.05) 0.00  (0.00) 0.00  (0.00) 0.00 [1]   (NA) 0.03  (0.06)
Eosinophils Week 1 Number Analyzed 42 participants 39 participants 43 participants 40 participants 43 participants 42 participants
0.02  (0.06) 0.02  (0.12) 0.01  (0.07) 0.04  (0.10) 0.02  (0.11) -0.02  (0.12)
Eosinophils Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.02  (0.08) 0.04  (0.26) 0.00  (0.08) 0.05  (0.11) 0.00  (0.11) 0.01  (0.11)
Eosinophils Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.03  (0.09) 0.04  (0.26) 0.01  (0.08) 0.02  (0.11) 0.03  (0.09) 0.00  (0.18)
Eosinophils Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 40 participants 40 participants
0.04  (0.10) 0.02  (0.19) 0.00  (0.08) 0.01  (0.09) 0.05  (0.16) -0.01  (0.17)
Eosinophils Week 8 Number Analyzed 39 participants 37 participants 37 participants 34 participants 40 participants 40 participants
0.01  (0.09) 0.01  (0.18) 0.01  (0.08) 0.04  (0.17) 0.05  (0.18) -0.03  (0.16)
Eosinophils Week 12 Number Analyzed 38 participants 38 participants 37 participants 34 participants 40 participants 38 participants
0.02  (0.09) 0.03  (0.22) 0.00  (0.09) 0.00  (0.08) 0.03  (0.13) -0.03  (0.11)
Eosinophils SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.05  (0.06) 0.08  (0.10) 0.10  (0.00) 0.00  (0.00) -0.10 [1]   (NA) 0.07  (0.06)
Leukocytes Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
0.16  (1.30) -0.59  (1.34) -0.15  (1.43) -0.63  (1.82) -0.19  (1.51) -0.48  (0.90)
Leukocytes Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.18  (1.36) -0.56  (1.31) -0.22  (1.43) -0.42  (1.34) -0.31  (1.80) -0.46  (1.29)
Leukocytes Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.17  (1.51) -0.36  (1.31) -0.23  (1.38) -0.54  (1.14) -0.36  (1.73) -0.34  (1.24)
Leukocytes Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.22  (1.25) -0.50  (1.95) -0.47  (1.49) -0.57  (1.34) -0.45  (2.02) -0.45  (1.12)
Leukocytes Week 8 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 40 participants
-0.10  (1.34) -0.67  (1.55) -0.24  (1.94) -0.37  (1.55) -0.30  (1.76) -0.45  (0.87)
Leukocytes Week 12 Number Analyzed 39 participants 38 participants 37 participants 34 participants 40 participants 38 participants
0.00  (1.37) -0.28  (1.68) -0.47  (1.67) -0.51  (1.41) -0.50  (1.44) -0.48  (1.09)
Leukocytes SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.05  (0.98) 1.15  (2.54) 0.95  (1.43) -0.65  (0.78) 0.20 [1]   (NA) 0.30  (0.40)
Lymphocytes Week 1 Number Analyzed 42 participants 39 participants 41 participants 40 participants 43 participants 42 participants
0.12  (0.36) -0.05  (0.30) 0.15  (0.42) 0.13  (0.34) 0.14  (0.46) 0.00  (0.45)
Lymphocytes Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.08  (0.32) -0.11  (0.30) 0.09  (0.34) 0.09  (0.40) 0.12  (0.34) -0.08  (0.37)
Lymphocytes Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.06  (0.40) -0.04  (0.33) 0.15  (0.43) 0.08  (0.42) 0.11  (0.36) 0.06  (0.36)
Lymphocytes Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 40 participants 40 participants
0.08  (0.46) -0.08  (0.43) 0.03  (0.31) 0.04  (0.43) 0.05  (0.37) -0.05  (0.40)
Lymphocytes Week 8 Number Analyzed 39 participants 37 participants 37 participants 34 participants 40 participants 40 participants
0.02  (0.37) -0.04  (0.31) 0.09  (0.40) 0.11  (0.33) 0.15  (0.45) 0.06  (0.42)
Lymphocytes Week 12 Number Analyzed 38 participants 38 participants 37 participants 34 participants 40 participants 38 participants
0.08  (0.38) 0.01  (0.35) 0.06  (0.38) 0.07  (0.48) 0.14  (0.38) -0.04  (0.37)
Lymphocytes SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.25  (0.24) 0.25  (0.40) 0.23  (0.19) 0.25  (0.21) 0.00 [1]   (NA) 0.50  (0.44)
Monocytes Week 1 Number Analyzed 42 participants 39 participants 41 participants 40 participants 43 participants 42 participants
0.02  (0.16) -0.01  (0.12) 0.02  (0.15) 0.02  (0.11) 0.02  (0.17) -0.03  (0.14)
Monocytes Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.00  (0.14) -0.04  (0.13) 0.00  (0.14) 0.04  (0.15) -0.04  (0.17) -0.03  (0.15)
Monocytes Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.03  (0.16) -0.01  (0.11) 0.01  (0.15) 0.03  (0.13) -0.01  (0.17) 0.02  (0.17)
Monocytes Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 40 participants 40 participants
0.01  (0.15) -0.01  (0.18) 0.02  (0.15) 0.00  (0.11) -0.02  (0.22) -0.03  (0.18)
Monocytes Week 8 Number Analyzed 39 participants 37 participants 37 participants 34 participants 40 participants 40 participants
-0.02  (0.15) -0.03  (0.11) 0.00  (0.16) -0.01  (0.14) -0.04  (0.17) -0.02  (0.15)
Monocytes Week 12 Number Analyzed 38 participants 38 participants 37 participants 34 participants 40 participants 38 participants
0.01  (0.16) 0.00  (0.14) -0.02  (0.15) -0.01  (0.18) -0.07  (0.17) -0.01  (0.14)
Monocytes SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.10  (0.22) 0.10  (0.22) 0.03  (0.10) 0.00  (0.00) -0.30 [1]   (NA) -0.07  (0.21)
Neutrophils Week 1 Number Analyzed 42 participants 39 participants 41 participants 40 participants 43 participants 42 participants
-0.02  (1.16) -0.55  (1.12) -0.32  (1.25) -0.81  (1.81) -0.37  (1.20) -0.44  (0.76)
Neutrophils Week 2 Number Analyzed 41 participants 38 participants 41 participants 39 participants 40 participants 41 participants
0.09  (1.29) -0.43  (1.05) -0.31  (1.33) -0.59  (1.09) -0.41  (1.64) -0.36  (1.13)
Neutrophils Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.04  (1.30) -0.35  (1.07) -0.39  (1.31) -0.68  (1.02) -0.48  (1.60) -0.40  (1.18)
Neutrophils Week 6 Number Analyzed 40 participants 38 participants 38 participants 36 participants 40 participants 40 participants
-0.36  (0.98) -0.43  (1.64) -0.49  (1.38) -0.54  (1.16) -0.50  (1.78) -0.36  (1.01)
Neutrophils Week 8 Number Analyzed 39 participants 37 participants 37 participants 34 participants 40 participants 40 participants
-0.13  (1.18) -0.61  (1.40) -0.34  (1.72) -0.57  (1.28) -0.45  (1.61) -0.47  (0.80)
Neutrophils Week 12 Number Analyzed 38 participants 38 participants 37 participants 34 participants 40 participants 38 participants
-0.11  (1.17) -0.33  (1.50) -0.49  (1.50) -0.57  (1.20) -0.59  (1.28) -0.39  (0.93)
Neutrophils SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.45  (0.79) 0.75  (1.88) 0.65  (1.20) -0.95  (0.49) 0.50 [1]   (NA) -0.13  (0.38)
[1]
Value was not evaluable because only one participant was analyzed.
22.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Hide Description Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: mmol/L
Calcium Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.010  (0.076) 0.011  (0.088) -0.021  (0.126) -0.017  (0.076) 0.000  (0.077) -0.010  (0.080)
Calcium Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-0.003  (0.082) 0.034  (0.094) -0.007  (0.092) 0.004  (0.074) 0.006  (0.088) -0.006  (0.085)
Calcium Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.029  (0.073) 0.012  (0.099) -0.020  (0.106) -0.008  (0.074) 0.005  (0.099) -0.010  (0.084)
Calcium Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.033  (0.070) 0.009  (0.079) -0.019  (0.091) -0.008  (0.092) -0.026  (0.086) -0.027  (0.100)
Calcium Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.023  (0.084) 0.001  (0.106) -0.027  (0.099) 0.019  (0.089) -0.002  (0.089) -0.016  (0.084)
Calcium Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.011  (0.095) 0.025  (0.092) -0.038  (0.120) 0.001  (0.093) -0.019  (0.121) -0.001  (0.092)
Calcium SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.095  (0.083) -0.050  (0.109) -0.073  (0.045) -0.125  (0.134) 0.020 [1]   (NA) 0.020  (0.193)
Chloride Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
0.5  (1.8) 0.6  (2.0) 0.6  (2.3) 0.6  (2.5) 0.3  (2.1) 0.1  (1.8)
Chloride Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.0  (2.3) 0.1  (2.4) -0.3  (2.2) 0.4  (2.3) 0.5  (2.1) 0.1  (1.9)
Chloride Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
0.1  (1.8) 0.8  (2.1) 0.0  (2.5) 0.2  (2.3) -0.1  (2.6) -0.1  (1.9)
Chloride Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.1  (2.1) 0.0  (2.3) -0.6  (1.7) 0.0  (2.4) -0.1  (3.0) 0.1  (2.0)
Chloride Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
0.2  (2.1) 0.3  (2.3) 0.3  (2.0) -0.1  (2.9) 0.1  (2.4) 0.1  (2.3)
Chloride Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
0.3  (1.7) -0.1  (2.5) -0.2  (2.0) 0.2  (2.3) 0.8  (2.4) 0.1  (2.2)
Chloride SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
1.0  (1.6) 3.0  (2.7) 0.5  (5.4) 2.0  (0.0) 0.0 [1]   (NA) 0.3  (2.1)
Potassium Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
0.08  (0.45) 0.08  (0.33) 0.05  (0.41) 0.02  (0.36) -0.03  (0.32) 0.04  (0.29)
Potassium Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.03  (0.30) 0.08  (0.33) 0.02  (0.32) -0.06  (0.29) 0.05  (0.37) -0.03  (0.39)
Potassium Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.09  (0.40) 0.12  (0.41) 0.09  (0.38) 0.01  (0.34) 0.05  (0.40) 0.03  (0.33)
Potassium Week 6 Number Analyzed 39 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.04  (0.32) 0.11  (0.35) -0.03  (0.31) -0.07  (0.33) -0.07  (0.34) -0.02  (0.35)
Potassium Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
0.01  (0.39) 0.07  (0.36) 0.12  (0.38) -0.06  (0.38) -0.12  (0.40) 0.02  (0.35)
Potassium Week 12 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 39 participants
-0.05  (0.35) 0.08  (0.34) 0.08  (0.37) -0.06  (0.37) -0.07  (0.37) -0.06  (0.33)
Potassium SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.10  (0.36) 0.10  (0.37) -0.10  (0.29) -0.45  (0.07) 0.20 [1]   (NA) -0.20  (0.30)
Magnesium Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.010  (0.074) -0.002  (0.052) -0.020  (0.069) 0.005  (0.079) -0.007  (0.077) -0.009  (0.064)
Magnesium Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-0.012  (0.063) -0.004  (0.064) -0.010  (0.065) 0.001  (0.068) -0.017  (0.086) 0.005  (0.075)
Magnesium Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.023  (0.077) -0.004  (0.062) -0.017  (0.046) 0.008  (0.071) -0.017  (0.067) -0.013  (0.070)
Magnesium Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.013  (0.054) -0.014  (0.053) -0.013  (0.057) -0.008  (0.065) -0.020  (0.073) -0.017  (0.063)
Magnesium Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.026  (0.070) -0.023  (0.042) -0.023  (0.063) 0.003  (0.071) -0.019  (0.072) -0.021  (0.058)
Magnesium Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.014  (0.093) 0.007  (0.074) -0.025  (0.069) 0.009  (0.074) -0.017  (0.075) -0.008  (0.056)
Magnesium SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.053  (0.093) 0.110  (0.295) -0.035  (0.047) -0.050  (0.057) -0.060 [1]   (NA) -0.023  (0.025)
Sodium Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.1  (1.8) 0.2  (1.7) 0.3  (2.7) 0.1  (1.9) 0.0  (2.2) 0.0  (1.4)
Sodium Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-0.3  (1.7) -0.2  (1.4) -0.4  (1.8) 0.0  (2.0) 0.2  (2.3) 0.0  (1.5)
Sodium Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.2  (1.7) 0.2  (1.7) 0.2  (1.7) -0.2  (1.7) -0.1  (2.3) -0.2  (1.7)
Sodium Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.5  (2.0) -0.1  (2.1) -0.8  (1.6) -0.1  (1.9) -0.1  (2.9) -0.3  (1.7)
Sodium Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.6  (2.0) 0.0  (2.8) -0.2  (1.8) -0.2  (2.0) -0.1  (2.2) -0.6  (2.0)
Sodium Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.4  (2.0) -0.2  (1.7) -0.1  (1.7) -0.2  (2.0) -0.2  (2.4) -0.3  (1.9)
Sodium SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.5  (2.1) 0.8  (1.7) -2.0  (2.2) -2.0  (2.8) -1.0 [1]   (NA) -1.7  (1.2)
Urea Nitrogen Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.16  (1.09) 0.11  (1.12) 0.27  (1.19) 0.34  (1.22) 0.27  (1.24) 0.21  (0.88)
Urea Nitrogen Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.00  (1.16) -0.03  (1.25) 0.24  (1.16) 0.16  (1.17) 0.27  (1.17) 0.37  (1.03)
Urea Nitrogen Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.14  (1.16) 0.48  (1.52) 0.50  (1.31) -0.03  (1.20) -0.11  (1.08) 0.15  (1.04)
Urea Nitrogen Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.12  (0.96) 0.21  (1.40) 0.41  (1.14) 0.19  (1.31) 0.29  (1.14) 0.12  (0.93)
Urea Nitrogen Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.28  (1.29) 0.14  (1.33) 0.32  (1.08) -0.08  (1.58) 0.33  (1.30) 0.35  (0.88)
Urea Nitrogen Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.17  (1.35) -0.04  (1.37) 0.39  (1.14) 0.08  (1.13) 0.13  (1.08) 0.01  (0.85)
Urea Nitrogen SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.65  (1.74) 0.80  (1.19) 0.78  (3.27) -0.65  (2.05) -0.30 [1]   (NA) 0.77  (1.27)
Cholesterol Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.04  (0.47) -0.06  (0.54) 0.00  (0.65) -0.09  (0.59) 0.12  (0.65) 0.06  (0.34)
Cholesterol Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-0.13  (0.71) 0.03  (0.63) 0.12  (0.58) -0.11  (0.52) 0.12  (1.04) 0.05  (0.57)
Cholesterol Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.06  (0.59) 0.04  (0.63) 0.17  (0.55) -0.31  (0.88) 0.00  (1.30) 0.05  (0.66)
Cholesterol Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
0.05  (0.46) -0.02  (0.73) 0.17  (0.56) -0.24  (0.70) -0.24  (1.32) 0.08  (0.60)
Cholesterol Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.08  (0.67) -0.17  (0.68) 0.16  (0.64) -0.13  (0.83) -0.17  (1.22) 0.01  (0.48)
Cholesterol Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.20  (0.88) -0.07  (0.62) 0.11  (0.62) -0.18  (0.77) 0.01  (1.29) -0.05  (0.76)
Cholesterol SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.28  (0.30) -0.83  (1.56) 0.38  (0.52) -0.80  (0.14) 0.20 [1]   (NA) 0.40  (0.44)
Glucose Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 42 participants
0.50  (1.59) 0.12  (0.82) -0.14  (1.00) -0.06  (1.14) 0.07  (1.10) 0.22  (0.70)
Glucose Week 2 Number Analyzed 41 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.29  (1.62) 0.17  (1.23) -0.05  (0.92) -0.20  (1.13) 0.03  (1.09) 0.05  (0.67)
Glucose Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.37  (1.42) 0.25  (1.22) -0.12  (1.03) -0.09  (1.24) 0.37  (1.20) 0.19  (0.92)
Glucose Week 6 Number Analyzed 39 participants 38 participants 38 participants 37 participants 40 participants 40 participants
0.44  (1.42) 0.30  (1.15) -0.04  (1.26) 0.02  (1.60) 0.21  (1.30) 0.29  (1.27)
Glucose Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
0.37  (1.48) 0.22  (1.48) -0.15  (0.87) -0.06  (1.43) 0.11  (1.10) 0.03  (0.97)
Glucose Week 12 Number Analyzed 39 participants 37 participants 38 participants 35 participants 40 participants 39 participants
0.22  (1.27) 0.01  (1.08) 0.02  (1.35) -0.17  (1.23) -0.15  (0.88) 0.04  (0.95)
Glucose SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.40  (0.48) 0.75  (0.89) -0.33  (0.67) -0.25  (0.49) 0.20 [1]   (NA) -0.17  (0.61)
[1]
Value was not evaluable because only one participant was analyzed.
23.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Hide Description Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: U/L
Lactate Dehydrogenase Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-2.0  (29.4) 1.1  (24.8) -5.0  (24.1) -0.3  (21.4) -4.6  (18.9) -3.4  (19.7)
Lactate Dehydrogenase Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-4.9  (26.4) -2.5  (25.2) -3.5  (22.1) 0.4  (27.6) -7.6  (27.4) -5.1  (20.1)
Lactate Dehydrogenase Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-4.9  (22.4) 1.7  (31.9) -8.1  (16.7) 5.0  (43.5) -4.5  (37.7) -4.4  (15.4)
Lactate Dehydrogenase Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-5.0  (27.7) -1.4  (25.2) -7.3  (20.3) 2.0  (16.2) -11.0  (27.5) -3.5  (22.6)
Lactate Dehydrogenase Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-5.5  (27.4) 0.5  (25.2) -12.3  (22.2) -0.8  (18.9) -10.7  (33.1) -3.7  (27.5)
Lactate Dehydrogenase Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-4.9  (28.1) 2.9  (26.7) -7.5  (25.1) -0.3  (20.6) -5.6  (33.1) -4.4  (24.8)
Lactate Dehydrogenase SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-1.5  (12.9) -5.0  (18.4) 3.3  (81.2) -45.5  (16.3) 15.0 [1]   (NA) 32.3  (34.2)
Alkaline Phosphatase Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-1.8  (6.3) -0.5  (6.0) -3.5  (8.2) -3.8  (7.7) -1.9  (5.3) -2.3  (5.7)
Alkaline Phosphatase Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-3.0  (12.7) 0.0  (7.4) -2.5  (10.5) -2.7  (8.2) -1.6  (6.5) -1.7  (7.7)
Alkaline Phosphatase Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-2.4  (8.7) -1.9  (9.2) -6.2  (9.8) -4.3  (9.4) -2.6  (8.1) -1.7  (7.8)
Alkaline Phosphatase Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-3.0  (8.3) -1.8  (9.0) -5.5  (10.0) -2.4  (8.6) -2.1  (9.6) -1.4  (7.5)
Alkaline Phosphatase Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-4.3  (12.2) -1.7  (8.0) -4.2  (11.2) -2.1  (10.0) -1.1  (11.3) -1.9  (7.2)
Alkaline Phosphatase Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-2.0  (8.1) 0.3  (7.2) -2.4  (11.8) -0.4  (9.0) -0.5  (10.4) -0.4  (8.4)
Alkaline Phosphatase SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-0.5  (7.4) 9.8  (8.9) 7.8  (15.3) -3.0  (5.7) 3.0 [1]   (NA) 3.0  (1.0)
Alanine Aminotransferase Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
2.0  (7.7) 2.1  (10.4) -1.7  (13.7) 1.6  (12.2) 0.7  (8.9) 1.2  (9.1)
Alanine Aminotransferase Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.3  (6.5) 1.9  (9.0) 2.0  (29.8) -0.9  (7.7) -0.2  (10.2) 1.6  (11.5)
Alanine Aminotransferase Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.2  (7.0) 1.1  (8.6) 0.8  (18.7) -0.4  (10.2) 0.4  (14.7) 1.0  (13.3)
Alanine Aminotransferase Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
3.9  (18.9) 1.1  (8.9) -0.6  (11.7) 3.5  (20.9) -1.7  (13.7) 1.1  (12.5)
Alanine Aminotransferase Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
1.8  (10.8) 2.2  (10.2) 0.1  (10.5) -0.4  (9.7) -1.1  (14.5) 0.8  (9.0)
Alanine Aminotransferase Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-1.3  (7.5) 1.8  (9.9) -1.0  (10.8) -0.9  (9.1) -0.9  (14.6) -0.4  (10.6)
Alanine Aminotransferase SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-3.8  (3.0) 4.3  (3.4) 26.5  (42.1) -6.0  (8.5) 16.0 [1]   (NA) -3.3  (3.1)
Aspartate Aminotransferase Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
0.5  (6.1) 2.0  (10.8) -3.0  (15.2) 1.9  (11.5) 0.3  (6.3) -0.5  (7.2)
Aspartate Aminotransferase Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-1.0  (3.8) 0.4  (4.9) -1.9  (19.1) -0.9  (4.7) -0.5  (6.1) 0.9  (13.4)
Aspartate Aminotransferase Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-1.1  (4.8) -0.1  (5.8) -2.5  (17.5) -0.4  (5.9) 0.6  (8.2) -0.4  (7.5)
Aspartate Aminotransferase Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
1.5  (10.6) 0.8  (6.0) -0.9  (9.5) 4.0  (15.7) -1.4  (7.0) -1.4  (6.5)
Aspartate Aminotransferase Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
0.0  (5.1) 0.2  (6.7) -1.4  (5.4) -1.4  (4.6) -0.4  (8.3) -0.8  (6.3)
Aspartate Aminotransferase Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-1.3  (5.5) 1.1  (7.9) -1.4  (8.3) -0.3  (4.8) -0.5  (7.3) -0.9  (5.2)
Aspartate Aminotransferase SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-2.8  (1.7) -0.3  (2.1) 11.5  (23.5) -4.0  (2.8) 9.0 [1]   (NA) 0.7  (2.5)
Gamma Glutamyl Transferase Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
0.6  (6.4) -0.8  (14.1) -2.0  (10.7) -7.5  (42.1) 1.6  (22.9) -0.8  (6.3)
Gamma Glutamyl Transferase Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.2  (8.7) -1.6  (11.1) 0.2  (14.2) -1.2  (8.0) -1.9  (6.5) 0.4  (15.0)
Gamma Glutamyl Transferase Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.7  (8.5) -1.9  (11.8) 1.8  (18.6) -2.6  (12.8) -0.4  (8.4) -1.4  (14.1)
Gamma Glutamyl Transferase Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
1.8  (10.5) -1.8  (13.8) -2.9  (13.1) -2.9  (7.3) -2.1  (9.3) -1.1  (12.9)
Gamma Glutamyl Transferase Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
2.4  (13.7) -1.9  (14.9) -0.9  (18.4) -2.6  (13.6) -2.5  (9.4) 3.1  (29.5)
Gamma Glutamyl Transferase Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.4  (10.9) -2.2  (13.3) -1.1  (21.7) -0.6  (11.2) -0.4  (11.1) -0.9  (12.2)
Gamma Glutamyl Transferase SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
-8.0  (13.4) 1.3  (3.9) 19.8  (23.3) -16.5  (24.7) 37.0 [1]   (NA) 3.0  (3.5)
[1]
Value was not evaluable because only one participant was analyzed.
24.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Hide Description Creatinine and bilirubin were measured in micromols per liter (μmol/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: μmol/L
Creatinine Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
0.6  (7.0) 2.7  (10.1) 1.4  (8.6) 0.6  (8.1) 0.7  (8.4) -0.7  (7.7)
Creatinine Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
0.0  (7.1) -0.8  (8.2) -0.4  (10.1) -0.7  (8.5) -0.1  (8.3) 0.0  (7.1)
Creatinine Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
0.0  (5.8) 1.3  (9.1) 0.6  (7.9) -1.7  (8.1) 0.6  (8.1) 1.6  (7.2)
Creatinine Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-1.1  (7.8) 1.6  (10.5) -0.1  (10.6) -0.6  (7.9) -0.1  (8.1) -0.5  (11.1)
Creatinine Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-1.1  (6.2) -0.4  (7.4) -1.0  (9.6) -2.6  (8.4) -0.1  (7.6) 0.1  (8.3)
Creatinine Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-1.6  (7.8) -0.2  (7.0) 0.7  (12.0) -0.7  (9.1) 0.1  (9.0) -0.7  (7.2)
Creatinine SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
1.5  (4.4) 6.0  (4.3) -6.5  (4.4) -10.5  (16.3) 9.0 [1]   (NA) 1.3  (6.4)
Bilirubin Week 1 Number Analyzed 42 participants 39 participants 42 participants 40 participants 43 participants 43 participants
-0.53  (3.10) -1.79  (4.50) -0.52  (2.81) -0.55  (4.49) 0.57  (5.73) 0.14  (4.16)
Bilirubin Week 2 Number Analyzed 42 participants 39 participants 41 participants 39 participants 42 participants 42 participants
-0.35  (2.85) -0.86  (5.05) -0.48  (3.40) -0.38  (3.60) -0.99  (2.98) 0.27  (3.69)
Bilirubin Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 41 participants
-0.70  (3.26) -1.70  (4.92) -0.26  (3.53) -0.04  (2.74) 0.76  (4.27) 0.70  (4.52)
Bilirubin Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.51  (3.13) -1.15  (4.59) 0.35  (3.44) -0.33  (3.94) 0.11  (4.19) -0.30  (4.28)
Bilirubin Week 8 Number Analyzed 39 participants 38 participants 38 participants 34 participants 40 participants 40 participants
-0.21  (3.81) -0.98  (4.68) -0.30  (3.20) -0.43  (4.52) -0.15  (3.79) -0.02  (4.41)
Bilirubin Week 12 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 39 participants
-0.74  (3.43) -1.02  (5.24) -0.73  (2.98) -1.20  (3.37) -0.43  (3.68) -0.34  (3.45)
Bilirubin SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
2.05  (2.16) -1.23  (2.62) -0.30  (3.87) -0.25  (0.78) -1.50 [1]   (NA) 1.40  (2.96)
[1]
Value was not evaluable because only one participant was analyzed.
25.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
Hide Description C Reactive Protein was measured in milligrams per liters (mg/L).
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 1 Number Analyzed 15 participants 10 participants 6 participants 8 participants 12 participants 10 participants
-2.110  (5.255) -5.367  (11.806) -0.775  (2.020) -2.635  (2.550) -5.108  (10.013) -3.732  (3.997)
Week 2 Number Analyzed 11 participants 10 participants 7 participants 9 participants 9 participants 9 participants
1.821  (6.974) -6.985  (11.064) 0.576  (2.898) 2.743  (15.212) -6.763  (13.211) -3.042  (1.989)
Week 4 Number Analyzed 11 participants 10 participants 6 participants 7 participants 10 participants 8 participants
1.338  (11.182) -5.835  (8.594) -1.722  (5.596) 0.929  (8.047) -4.226  (9.865) 7.141  (32.344)
Week 6 Number Analyzed 14 participants 8 participants 7 participants 4 participants 8 participants 6 participants
2.978  (13.162) -5.930  (9.560) -4.516  (11.304) -0.595  (7.346) 1.799  (14.635) -6.598  (6.278)
Week 8 Number Analyzed 12 participants 8 participants 7 participants 4 participants 9 participants 5 participants
3.153  (18.764) -6.891  (15.192) -3.143  (10.844) 2.590  (7.755) 12.434  (47.447) -1.104  (5.201)
Week 12 Number Analyzed 10 participants 11 participants 6 participants 4 participants 8 participants 8 participants
7.279  (13.546) -5.193  (10.817) 0.695  (6.381) -3.033  (7.261) -9.890  (10.729) -5.368  (5.322)
SFU Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
8.000 [1]   (NA)
[1]
Value was not evaluable because only one participant was analyzed.
26.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Hide Description Urine pH was measured on a pH scale.
Time Frame Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
Overall Number of Participants Analyzed 42 39 43 40 43 43
Mean (Standard Deviation)
Unit of Measure: ph
Week 1 Number Analyzed 42 participants 39 participants 41 participants 40 participants 43 participants 43 participants
0.00  (0.79) -0.10  (0.79) -0.13  (0.88) -0.20  (0.88) -0.08  (0.82) -0.07  (0.90)
Week 2 Number Analyzed 42 participants 39 participants 39 participants 39 participants 42 participants 42 participants
0.06  (0.86) -0.06  (0.86) -0.10  (0.77) -0.23  (0.92) -0.18  (0.76) 0.06  (0.65)
Week 4 Number Analyzed 41 participants 39 participants 41 participants 39 participants 41 participants 40 participants
0.05  (0.87) -0.09  (0.76) -0.11  (0.95) -0.26  (0.89) -0.07  (0.73) -0.04  (0.74)
Week 6 Number Analyzed 40 participants 38 participants 38 participants 37 participants 40 participants 40 participants
-0.01  (0.73) -0.03  (0.68) -0.17  (0.69) -0.18  (0.86) -0.13  (0.81) 0.05  (0.86)
Week 8 Number Analyzed 39 participants 38 participants 38 participants 35 participants 40 participants 40 participants
-0.03  (0.92) -0.07  (0.83) -0.12  (1.07) -0.34  (0.79) -0.30  (0.91) 0.08  (0.75)
Week 12 Number Analyzed 39 participants 38 participants 37 participants 34 participants 40 participants 39 participants
-0.14  (0.79) -0.01  (0.85) 0.01  (0.70) -0.28  (0.85) -0.21  (0.99) -0.01  (0.85)
SFU Number Analyzed 4 participants 4 participants 4 participants 2 participants 1 participants 3 participants
0.25  (1.04) -0.25  (0.87) 0.50  (1.22) -1.00  (1.41) 0.50 [1]   (NA) -0.17  (0.29)
[1]
Value was not evaluable because only one participant was analyzed.
27.Secondary Outcome
Title Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Hide Description Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame From Baseline (Week 0) until Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.

Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.

Arm/Group Title Placebo (SS) Bimekizumab 64 mg Q4W (SS) Bimekizumab 160 mg Q4W (SS) Bimekizumab 160 mg w/ LD Q4W (SS) Bimekizumab 320 mg Q4W (SS) Bimekizumab 480 mg Q4W (SS)