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Trial record 1 of 1 for:    PS0008
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A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)

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: NCT03412747
Recruitment Status : Completed
First Posted : January 26, 2018
Results First Posted : March 2, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Interventions Drug: Bimekizumab
Drug: Adalimumab
Other: Placebo
Enrollment 478
Recruitment Details The study started to enroll patients in January 2018 and concluded in February 2020.
Pre-assignment Details This study included 4 periods: a Screening Period (2 to 5 weeks), an Initial Treatment Period (16 weeks), a Maintenance Treatment Period (40 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the final dose of study drug). Participant Flow refers to the Randomized Set.
Arm/Group Title Bimekizumab 320 Milligrams (mg) Q4W/Q8W Bimekizumab 320 mg Q4W Adalimumab
Hide Arm/Group Description Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
Period Title: Initial Treatment Period: Wk0-Wk16
Started 161 158 159
Completed 154 153 150
Not Completed 7 5 9
Reason Not Completed
Adverse Event             2             2             3
Death             0             0             1
Lack of Efficacy             0             0             1
Protocol Violation             0             0             2
Lost to Follow-up             0             2             1
Withdrawal by Subject             4             1             1
Participant moved out of state             1             0             0
Period Title: Maintenance Treatment Period: Wk16-Wk24
Started 154 153 150
Completed 149 152 149
Not Completed 5 1 1
Reason Not Completed
Adverse Event             3             1             0
Lack of Efficacy             1             0             0
Lost to Follow-up             0             0             1
Withdrawal by Subject             1             0             0
Period Title: Maintenance Treatment Period: Wk24-Wk56
Started 149 152 149
Completed 143 143 133
Not Completed 6 9 16
Reason Not Completed
Adverse Event             3             4             6
Lack of Efficacy             0             1             1
Lost to Follow-up             0             2             5
Withdrawal by Subject             3             1             4
Moving out of town             0             1             0
Arm/Group Title Bimekizumab 320 Milligrams (mg) Q4W/Q8W Bimekizumab 320 mg Q4W Adalimumab Total Title
Hide Arm/Group Description Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. [Not Specified]
Overall Number of Baseline Participants 161 158 159 478
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 158 participants 159 participants 478 participants
<=18 years
3
   1.9%
0
   0.0%
2
   1.3%
5
   1.0%
Between 18 and 65 years
145
  90.1%
147
  93.0%
137
  86.2%
429
  89.7%
>=65 years
13
   8.1%
11
   7.0%
20
  12.6%
44
   9.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 158 participants 159 participants 478 participants
44.0  (13.5) 45.3  (13.2) 45.5  (14.3) 44.9  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 158 participants 159 participants 478 participants
Female
49
  30.4%
56
  35.4%
45
  28.3%
150
  31.4%
Male
112
  69.6%
102
  64.6%
114
  71.7%
328
  68.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 158 participants 159 participants 478 participants
Asian
13
   8.1%
10
   6.3%
11
   6.9%
34
   7.1%
Black or African American
2
   1.2%
2
   1.3%
2
   1.3%
6
   1.3%
Native Hawaiian or Other Pacific Islander
2
   1.2%
1
   0.6%
0
   0.0%
3
   0.6%
White
140
  87.0%
140
  88.6%
141
  88.7%
421
  88.1%
Other/Mixed
4
   2.5%
5
   3.2%
5
   3.1%
14
   2.9%
1.Primary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Hide Description The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
Arm/Group Title Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 319 159
Measure Type: Number
Unit of Measure: percentage of participants
86.2 47.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Risk Difference: BKZ-ADA calculated using stratified CMH.
Type of Statistical Test Non-Inferiority
Comments The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 39.3
Confidence Interval (2-Sided) 95%
30.9 to 47.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.459
Confidence Interval (2-Sided) 95%
4.709 to 11.816
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16
Hide Description The 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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
Arm/Group Title Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 319 159
Measure Type: Number
Unit of Measure: percentage of participants
85.3 57.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Risk Difference: BKZ-ADA calculated using stratified CMH.
Type of Statistical Test Non-Inferiority
Comments The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 28.2
Confidence Interval (2-Sided) 95%
19.7 to 36.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.341
Confidence Interval (2-Sided) 95%
2.785 to 6.765
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a PASI90 Response at Week 24
Hide Description The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W (RS) Bimekizumab 320 mg Q4W (RS) Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 161 158 319 159
Measure Type: Number
Unit of Measure: percentage of participants
85.1 86.1 85.6 51.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.231
Confidence Interval (2-Sided) 95%
3.515 to 11.046
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.750
Confidence Interval (2-Sided) 95%
3.657 to 9.041
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
Hide Description The 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. IGA response was defined as clear [0] with at least a two-category improvement from Baseline at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W (RS) Bimekizumab 320 mg Q4W (RS) Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 161 158 319 159
Measure Type: Number
Unit of Measure: percentage of participants
87.0 86.1 86.5 57.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.724
Confidence Interval (2-Sided) 95%
2.683 to 8.318
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.762
Confidence Interval (2-Sided) 95%
3.014 to 7.523
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a PASI75 Response at Week 4
Hide Description The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 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 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
Arm/Group Title Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 319 159
Measure Type: Number
Unit of Measure: percentage of participants
76.5 31.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.103
Confidence Interval (2-Sided) 95%
4.637 to 10.880
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With a PASI100 Response at Week 16
Hide Description The PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. 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 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 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.
Arm/Group Title Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 319 159
Measure Type: Number
Unit of Measure: percentage of participants
60.8 23.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.974
Confidence Interval (2-Sided) 95%
3.230 to 7.661
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With a PASI100 Response at Week 24
Hide Description The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W (RS) Bimekizumab 320 mg Q4W (RS) Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) Adalimumab (RS)
Hide Arm/Group Description:
Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 161 158 319 159
Measure Type: Number
Unit of Measure: percentage of participants
65.8 67.7 66.8 29.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.249
Confidence Interval (2-Sided) 95%
3.207 to 8.593
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS), Adalimumab (RS)
Comments Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for the comparison of treatment groups were based on the CMH test from the general association.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.974
Confidence Interval (2-Sided) 95%
3.257 to 7.594
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With a PASI90 Response at Week 56
Hide Description PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/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 min possible PASI score is 0=no disease, max score is 72=maximal disease.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ.
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W (RS) Bimekizumab 320 mg Q4W (RS)
Hide Arm/Group Description:
Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 161 158
Measure Type: Number
Unit of Measure: percentage of participants
82.6 84.8
9.Secondary Outcome
Title Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
Hide Description 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. IGA response was defined as clear [0]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ.
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W (RS) Bimekizumab 320 mg Q4W (RS)
Hide Arm/Group Description:
Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Overall Number of Participants Analyzed 161 158
Measure Type: Number
Unit of Measure: percentage of participants
83.2 82.3
10.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Hide Description The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Week 24
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Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose of IMP.
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS)
Hide Arm/Group Description:
Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 161 158 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
310.44
(256.52 to 372.34)
300.71
(247.60 to 361.83)
297.54
(244.77 to 358.31)
11.Secondary Outcome
Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Hide Description The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS)
Hide Arm/Group Description:
Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 161 158 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
1.37
(0.03 to 7.66)
5.61
(1.53 to 14.38)
6.98
(2.27 to 16.30)
12.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Hide Description The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS)
Hide Arm/Group Description:
Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 161 158 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
8.30
(3.05 to 18.07)
4.16
(0.86 to 12.17)
6.98
(2.27 to 16.29)
13.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Description The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
Arm/Group Title Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Hide Arm/Group Description:
This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
Overall Number of Participants Analyzed 154 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
231.38
(191.68 to 276.88)
262.41
(235.37 to 291.71)
14.Secondary Outcome
Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Description The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
Arm/Group Title Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Hide Arm/Group Description:
This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
Overall Number of Participants Analyzed 154 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
7.03
(3.04 to 13.86)
5.34
(3.05 to 8.67)
15.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Description The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to Safety Follow-Up Visit (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.
Arm/Group Title Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Hide Arm/Group Description:
This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
Overall Number of Participants Analyzed 154 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
4.37
(1.42 to 10.19)
4.62
(2.53 to 7.75)
Time Frame Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72)
Adverse Event Reporting Description Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
 
Arm/Group Title Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS) Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Hide Arm/Group Description Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS). Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set). This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
All-Cause Mortality
Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS) Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)      0/158 (0.00%)      1/159 (0.63%)      0/154 (0.00%)      0/468 (0.00%)    
Hide Serious Adverse Events
Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS) Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/161 (0.62%)      4/158 (2.53%)      5/159 (3.14%)      8/154 (5.19%)      16/468 (3.42%)    
Blood and lymphatic system disorders           
Haemorrhagic anaemia * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Cardiac disorders           
Coronary artery stenosis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Eye disorders           
Retinal detachment * 1  0/161 (0.00%)  0 1/158 (0.63%)  1 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Gastrointestinal disorders           
Irritable bowel syndrome * 1  0/161 (0.00%)  0 1/158 (0.63%)  1 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Haemorrhoidal haemorrhage * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 0/468 (0.00%)  0
Pancreatitis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Gastric polyps * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Duodenal ulcer haemorrhage * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Umbilical hernia * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
General disorders           
Non-cardiac chest pain * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Immune system disorders           
Sarcoidosis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Infections and infestations           
Cellulitis * 1  1/161 (0.62%)  1 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 3/468 (0.64%)  3
Infected dermal cyst * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 0/468 (0.00%)  0
Anal abscess * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Appendicitis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Helicobacter infection * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Injury, poisoning and procedural complications           
Subdural haematoma * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Investigations           
Hepatic enzyme increased * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes mellitus inadequate control * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Type 2 diabetes mellitus * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 1/468 (0.21%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous cell carcinoma of the tongue * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 0/468 (0.00%)  0
Colon cancer * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Nervous system disorders           
Carotid artery stenosis * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 0/468 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous * 1  0/161 (0.00%)  0 1/158 (0.63%)  1 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Renal and urinary disorders           
Calculus urinary * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 1/159 (0.63%)  1 0/154 (0.00%)  0 0/468 (0.00%)  0
Reproductive system and breast disorders           
Ovarian cyst ruptured * 1  0/161 (0.00%)  0 1/158 (0.63%)  1 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Skin and subcutaneous tissue disorders           
Subcutaneous abscess * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 0/154 (0.00%)  0 1/468 (0.21%)  1
Erysipelas * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
Vascular disorders           
Hypertension * 1  0/161 (0.00%)  0 0/158 (0.00%)  0 0/159 (0.00%)  0 1/154 (0.65%)  1 0/468 (0.00%)  0
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) Bimekizumab 320 mg Q4W Through Week 24 (SS) Adalimumab Through Week 24 (SS) Any Bimekizumab 320 mg Q8W (BKZ Set) Any Bimekizumab 320 mg Q4W (BKZ Set)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/161 (40.37%)      61/158 (38.61%)      62/159 (38.99%)      60/154 (38.96%)      182/468 (38.89%)    
Gastrointestinal disorders           
Diarrhoea * 1  5/161 (3.11%)  5 8/158 (5.06%)  9 4/159 (2.52%)  6 5/154 (3.25%)  5 14/468 (2.99%)  16
Infections and infestations           
Nasopharyngitis * 1  27/161 (16.77%)  40 32/158 (20.25%)  46 38/159 (23.90%)  50 28/154 (18.18%)  35 79/468 (16.88%)  113
Oral candidiasis * 1  19/161 (11.80%)  26 15/158 (9.49%)  20 0/159 (0.00%)  0 17/154 (11.04%)  26 66/468 (14.10%)  104
Upper respiratory tract infection * 1  12/161 (7.45%)  14 7/158 (4.43%)  8 15/159 (9.43%)  21 13/154 (8.44%)  16 30/468 (6.41%)  40
Pharyngitis * 1  5/161 (3.11%)  7 4/158 (2.53%)  4 1/159 (0.63%)  1 11/154 (7.14%)  11 13/468 (2.78%)  14
Vascular disorders           
Hypertension * 1  9/161 (5.59%)  10 6/158 (3.80%)  6 13/159 (8.18%)  13 4/154 (2.60%)  4 19/468 (4.06%)  20
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03412747    
Other Study ID Numbers: PS0008
2016-003392-22 ( EudraCT Number )
First Submitted: January 22, 2018
First Posted: January 26, 2018
Results First Submitted: February 4, 2022
Results First Posted: March 2, 2022
Last Update Posted: July 22, 2022