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Trial record 1 of 1 for:    PS0009
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A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE VIVID)

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: NCT03370133
Recruitment Status : Completed
First Posted : December 12, 2017
Results First Posted : February 3, 2022
Last Update Posted : July 25, 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 Chronic Plaque Psoriasis
Psoriatic Arthritis
Interventions Drug: Bimekizumab
Drug: Ustekinumab
Other: Placebo
Enrollment 567
Recruitment Details This study started to enroll participants in December 2017 and concluded in December 2019.
Pre-assignment Details The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.
Arm/Group Title Placebo Bimekizumab (BKZ) 320 Milligrams (mg) Q4W Ustekinumab (Uste) Placebo/Bimekizumab 320 mg Q4W Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W Ustekinumab/Ustekinumab
Hide Arm/Group Description Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period). After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period.
Period Title: Initial Treatment Period (WK 16)
Started 83 321 163 0 0 0
Completed 74 306 157 0 0 0
Not Completed 9 15 6 0 0 0
Reason Not Completed
Adverse Event             5             5             2             0             0             0
Death             1             1             1             0             0             0
Lack of Efficacy             2             1             0             0             0             0
Protocol Violation             0             0             2             0             0             0
Lost to Follow-up             0             3             0             0             0             0
Withdrawal by Subject             1             2             1             0             0             0
Non-compliance             0             1             0             0             0             0
Site closed             0             2             0             0             0             0
Period Title: Maintenance Treatment Period (WK 52)
Started 0 0 0 74 306 157
Completed 0 0 0 69 283 141
Not Completed 0 0 0 5 23 16
Reason Not Completed
Adverse Event             0             0             0             3             12             4
Lack of Efficacy             0             0             0             0             1             4
Protocol Violation             0             0             0             1             1             0
Lost to Follow-up             0             0             0             0             4             3
Withdrawal by Subject             0             0             0             1             4             4
Non-compliance             0             0             0             0             1             0
Consent Withdrawn for IMP Not Procedures             0             0             0             0             0             1
Arm/Group Title Placebo Bimekizumab (BKZ) 320 Milligrams (mg) Q4W Ustekinumab (Uste) Total Title
Hide Arm/Group Description Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. [Not Specified]
Overall Number of Baseline Participants 83 321 163 567
Hide Baseline Analysis Population Description
Baseline characteristics refer to the Randomized Set (RS) consisting of all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 321 participants 163 participants 567 participants
<=18 years
0
   0.0%
2
   0.6%
1
   0.6%
3
   0.5%
Between 18 and 65 years
73
  88.0%
285
  88.8%
144
  88.3%
502
  88.5%
>=65 years
10
  12.0%
34
  10.6%
18
  11.0%
62
  10.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 321 participants 163 participants 567 participants
49.7  (13.6) 45.2  (14.0) 46.0  (13.6) 46.1  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 321 participants 163 participants 567 participants
Female
23
  27.7%
92
  28.7%
46
  28.2%
161
  28.4%
Male
60
  72.3%
229
  71.3%
117
  71.8%
406
  71.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 321 participants 163 participants 567 participants
American Indian/Alaskan native
0
   0.0%
1
   0.3%
1
   0.6%
2
   0.4%
Asian
20
  24.1%
71
  22.1%
36
  22.1%
127
  22.4%
Black
0
   0.0%
9
   2.8%
3
   1.8%
12
   2.1%
White
63
  75.9%
237
  73.8%
120
  73.6%
420
  74.1%
Other/mixed
0
   0.0%
3
   0.9%
3
   1.8%
6
   1.1%
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 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 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
4.8 85.0 49.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) 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 (BKZ 320 mg Q4W vs PBO) 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 99.869
Confidence Interval (2-Sided) 95%
34.020 to 293.175
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 6.056
Confidence Interval (2-Sided) 95%
3.874 to 9.466
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16
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. 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.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
4.8 84.1 53.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) 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 (BKZ 320 mg Q4W vs PBO) 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 118.762
Confidence Interval (2-Sided) 95%
36.701 to 384.307
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 4.809
Confidence Interval (2-Sided) 95%
3.096 to 7.470
Estimation Comments [Not Specified]
3.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 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 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
0 58.6 20.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 25.590
Confidence Interval (2-Sided) 95%
9.063 to 72.253
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With an IGA 0 Response at Week 16
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. IGA response was defined as clear [0] 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.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
0 58.6 22.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 25.471
Confidence Interval (2-Sided) 95%
9.020 to 71.925
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 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 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
2.4 76.9 15.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 123.020
Confidence Interval (2-Sided) 95%
29.394 to 514.862
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 18.202
Confidence Interval (2-Sided) 95%
10.998 to 30.123
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
Hide Description

As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.

PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 54 229 107
Measure Type: Number
Unit of Measure: percentage of participants
16.7 77.3 68.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 16.258
Confidence Interval (2-Sided) 95%
7.356 to 35.931
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
Hide Description

A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.

PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 61 244 117
Measure Type: Number
Unit of Measure: percentage of participants
13.1 76.6 65.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 22.279
Confidence Interval (2-Sided) 95%
9.795 to 50.674
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
Hide Description As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 63 246 116
Measure Type: Number
Unit of Measure: percentage of participants
12.7 78.5 59.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 23.049
Confidence Interval (2-Sided) 95%
10.201 to 52.077
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
Hide Description Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 72 285 146
Measure Type: Number
Unit of Measure: percentage of participants
15.3 84.2 70.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
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 (BKZ 320 mg Q4W vs PBO) 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 37.696
Confidence Interval (2-Sided) 95%
16.920 to 83.987
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With a PASI90 Response 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 Randomized Set (RS) consisted of all randomized study participants.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
2.4 85.0 43.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 8.047
Confidence Interval (2-Sided) 95%
5.107 to 12.679
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With a PASI90 Response at Week 52
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 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.
Arm/Group Title Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 321 163
Measure Type: Number
Unit of Measure: percentage of participants
81.9 55.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 3.795
Confidence Interval (2-Sided) 95%
2.442 to 5.899
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants.
Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Unit of Measure: percentage of participants
4.8 81.9 52.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 4.379
Confidence Interval (2-Sided) 95%
2.850 to 6.730
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.
Arm/Group Title Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
Hide Arm/Group Description:
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
Overall Number of Participants Analyzed 321 163
Measure Type: Number
Unit of Measure: percentage of participants
78.2 60.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
Comments Odds ratio was 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 (BKZ 320 mg Q4W vs Ustekinumab) 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 2.412
Confidence Interval (2-Sided) 95%
1.573 to 3.699
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Time Frame From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
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 Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
238.41
(169.53 to 325.91)
287.26
(246.93 to 332.29)
247.62
(197.23 to 306.96)
15.Secondary Outcome
Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
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 end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
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 Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
7.97
(0.97 to 28.80)
5.06
(1.64 to 11.80)
10.14
(3.29 to 23.66)
16.Secondary Outcome
Title Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
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 end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
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 Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
Hide Arm/Group Description:
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
Overall Number of Participants Analyzed 83 321 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
24.39
(8.95 to 53.09)
6.08
(2.23 to 13.24)
5.99
(1.24 to 17.52)
17.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Time Frame From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
Hide Arm/Group Description:
After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.
Overall Number of Participants Analyzed 74 306 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
149.35
(114.24 to 191.85)
127.84
(111.58 to 145.81)
111.24
(90.80 to 134.91)
18.Secondary Outcome
Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
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 Week 16 to Safety Follow-Up (up to 52 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
Hide Arm/Group Description:
After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.
Overall Number of Participants Analyzed 74 306 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
9.88
(3.21 to 23.05)
6.19
(3.30 to 10.58)
7.46
(3.22 to 14.70)
19.Secondary Outcome
Title Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
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 Week 16 to Safety Follow-Up (up to 52 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
Hide Arm/Group Description:
After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.
Overall Number of Participants Analyzed 74 306 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
5.91
(1.22 to 17.27)
5.72
(2.95 to 9.99)
3.71
(1.01 to 9.51)
Time Frame Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
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 the 20-week Safety Follow-Up [SFU] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
 
Arm/Group Title Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
Hide Arm/Group Description During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS). During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS. During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS. This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS. This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS.
All-Cause Mortality
Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/83 (1.20%)      1/321 (0.31%)      1/163 (0.61%)      2/395 (0.51%)      1/163 (0.61%)    
Hide Serious Adverse Events
Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/83 (2.41%)      5/321 (1.56%)      5/163 (3.07%)      24/395 (6.08%)      13/163 (7.98%)    
Cardiac disorders           
Acute myocardial infarction * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 0/163 (0.00%)  0 2/395 (0.51%)  2 0/163 (0.00%)  0
Cardiac arrest * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 1/163 (0.61%)  1 1/395 (0.25%)  1 1/163 (0.61%)  1
Myocardial infarction * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 2/395 (0.51%)  2 0/163 (0.00%)  0
Eye disorders           
Macular hole * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Gastrointestinal disorders           
Haemorrhoids * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Colitis ulcerative * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
General disorders           
Death * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Infections and infestations           
Wound infection * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Urinary tract infection * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Gastroenteritis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Oesophageal candidiasis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Mastoiditis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Otitis externa * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Otitis media acute * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Pneumonia * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Infective tenosynovitis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Necrotising fasciitis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Subglottic laryngitis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Injury, poisoning and procedural complications           
Heart injury * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Tendon injury * 1  1/83 (1.20%)  1 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 0/163 (0.00%)  0
Toxicity to various agents * 1  1/83 (1.20%)  1 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 0/163 (0.00%)  0
Humerus fracture * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Tibia fracture * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Upper limb fracture * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Investigations           
Liver function test increased * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
False positive tuberculosis test * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes mellitus * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Musculoskeletal and connective tissue disorders           
Osteochondrosis * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Intervertebral disc protrusion * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Facet joint syndrome * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Arthritis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Spinal column stenosis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Oesophageal adenocarcinoma * 1  1/83 (1.20%)  1 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 0/163 (0.00%)  0
Gastric cancer * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Thyroid adenoma * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Nervous system disorders           
Intracranial aneurysm * 1  0/83 (0.00%)  0 1/321 (0.31%)  1 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Brain injury * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 1/163 (0.61%)  1 0/395 (0.00%)  0 1/163 (0.61%)  1
Cerebral infarction * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Hydrocephalus * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Vocal cord paresis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Haemorrhage in pregnancy * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Psychiatric disorders           
Alcoholism * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Suicide attempt * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 0/395 (0.00%)  0 1/163 (0.61%)  1
Respiratory, thoracic and mediastinal disorders           
Epistaxis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Skin and subcutaneous tissue disorders           
Psoriasis * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (0.00%)  0
Surgical and medical procedures           
Metabolic surgery * 1  0/83 (0.00%)  0 0/321 (0.00%)  0 0/163 (0.00%)  0 1/395 (0.25%)  1 0/163 (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%
Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/83 (20.48%)      87/321 (27.10%)      37/163 (22.70%)      192/395 (48.61%)      73/163 (44.79%)    
Infections and infestations           
Nasopharyngitis * 1  7/83 (8.43%)  8 30/321 (9.35%)  35 14/163 (8.59%)  15 86/395 (21.77%)  121 36/163 (22.09%)  53
Oral candidiasis * 1  0/83 (0.00%)  0 28/321 (8.72%)  30 0/163 (0.00%)  0 60/395 (15.19%)  98 1/163 (0.61%)  1
Upper respiratory tract infection * 1  2/83 (2.41%)  2 9/321 (2.80%)  9 5/163 (3.07%)  6 36/395 (9.11%)  48 18/163 (11.04%)  22
Urinary tract infection * 1  5/83 (6.02%)  5 6/321 (1.87%)  6 1/163 (0.61%)  1 12/395 (3.04%)  14 6/163 (3.68%)  7
Musculoskeletal and connective tissue disorders           
Back pain * 1  2/83 (2.41%)  2 3/321 (0.93%)  3 4/163 (2.45%)  4 10/395 (2.53%)  10 9/163 (5.52%)  10
Nervous system disorders           
Headache * 1  0/83 (0.00%)  0 11/321 (3.43%)  11 7/163 (4.29%)  10 16/395 (4.05%)  17 10/163 (6.13%)  14
Skin and subcutaneous tissue disorders           
Psoriasis * 1  5/83 (6.02%)  5 3/321 (0.93%)  4 2/163 (1.23%)  2 9/395 (2.28%)  11 2/163 (1.23%)  2
Vascular disorders           
Hypertension * 1  1/83 (1.20%)  1 7/321 (2.18%)  7 5/163 (3.07%)  5 14/395 (3.54%)  14 10/163 (6.13%)  11
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: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03370133    
Other Study ID Numbers: PS0009
2016-003425-42 ( EudraCT Number )
First Submitted: December 7, 2017
First Posted: December 12, 2017
Results First Submitted: January 5, 2022
Results First Posted: February 3, 2022
Last Update Posted: July 25, 2022