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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)

Primary Purpose

Chronic Plaque Psoriasis, Moderate to Severe Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Adalimumab
Placebo
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Bimekizumab, PSO, Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be at least 18 years of age
  • Chronic plaque PSO for at least 6 months prior to the Screening Visit
  • Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
  • Subject is a candidate for systemic PSO therapy and/or phototherapy
  • Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

  • Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab
  • Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
  • Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
  • Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
  • Subject has had previous exposure to adalimumab
  • Presence of active suicidal ideation or positive suicide behavior
  • Presence of moderately severe major depression or severe major depression
  • Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Sites / Locations

  • Ps0008 957
  • Ps0008 927
  • Ps0008 955
  • Ps0008 943
  • Ps0008 967
  • Ps0008 939
  • Ps0008 934
  • Ps0008 906
  • Ps0008 936
  • Ps0008 900
  • Ps0008 905
  • Ps0008 940
  • Ps0008 925
  • Ps0008 917
  • Ps0008 908
  • Ps0008 961
  • Ps0008 935
  • Ps0008 932
  • Ps0008 929
  • Ps0008 945
  • Ps0008 931
  • Ps0008 924
  • Ps0008 951
  • Ps0008 008
  • Ps0008 004
  • Ps0008 007
  • Ps0008 010
  • Ps0008 005
  • Ps0008 009
  • Ps0008 659
  • Ps0008 663
  • Ps0008 660
  • Ps0008 661
  • Ps0008 662
  • Ps0008 664
  • Ps0008 657
  • Ps0008 669
  • Ps0008 670
  • Ps0008 674
  • Ps0008 207
  • Ps0008 218
  • Ps0008 203
  • Ps0008 211
  • Ps0008 220
  • Ps0008 215
  • Ps0008 213
  • Ps0008 205
  • Ps0008 217
  • Ps0008 252
  • Ps0008 254
  • Ps0008 255
  • Ps0008 256
  • Ps0008 251
  • Ps0008 260
  • Ps0008 702
  • Ps0008 700
  • Ps0008 355
  • Ps0008 362
  • Ps0008 371
  • Ps0008 352
  • Ps0008 359
  • Ps0008 366
  • Ps0008 363
  • Ps0008 356
  • Ps0008 364
  • Ps0008 353
  • Ps0008 354
  • Ps0008 365
  • Ps0008 367
  • Ps0008 373
  • Ps0008 360
  • Ps0008 372
  • Ps0008 405
  • Ps0008 401
  • Ps0008 406
  • Ps0008 754
  • Ps0008 755

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Bimekizumab Arm 1

Bimekizumab Arm 2

Adalimumab Arm

Arm Description

Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
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.
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
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.

Secondary Outcome Measures

Percentage of Participants With a PASI90 Response at Week 24
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.
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
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.
Percentage of Participants With a PASI75 Response at Week 4
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.
Percentage of Participants With a PASI100 Response at Week 16
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.
Percentage of Participants With a PASI100 Response at Week 24
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.
Percentage of Participants With a PASI90 Response at Week 56
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.
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
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.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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.
Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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.
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)
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.
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)
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.
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)
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.

Full Information

First Posted
January 22, 2018
Last Updated
February 22, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03412747
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE SURE
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
Keywords
Bimekizumab, PSO, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimekizumab Arm 1
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Arm Title
Bimekizumab Arm 2
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Arm Title
Adalimumab Arm
Arm Type
Active Comparator
Arm Description
Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Adalimumab will be administered according to the labeling recommendations.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Primary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
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
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
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PASI90 Response at Week 24
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
Title
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
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
Title
Percentage of Participants With a PASI75 Response at Week 4
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
Title
Percentage of Participants With a PASI100 Response at Week 16
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
Title
Percentage of Participants With a PASI100 Response at Week 24
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
Title
Percentage of Participants With a PASI90 Response at Week 56
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
Title
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
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
Title
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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
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
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
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)
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)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be at least 18 years of age Chronic plaque PSO for at least 6 months prior to the Screening Visit Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale Subject is a candidate for systemic PSO therapy and/or phototherapy Female subject of child bearing potential must be willing to use highly effective method of contraception Exclusion Criteria: Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study Subject has had previous exposure to adalimumab Presence of active suicidal ideation or positive suicide behavior Presence of moderately severe major depression or severe major depression Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0008 957
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Ps0008 927
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ps0008 955
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ps0008 943
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Ps0008 967
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Ps0008 939
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Ps0008 934
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Ps0008 906
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Ps0008 936
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Ps0008 900
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Ps0008 905
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Ps0008 940
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Ps0008 925
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Ps0008 917
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Ps0008 908
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Ps0008 961
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Ps0008 935
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-35 20
Country
United States
Facility Name
Ps0008 932
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Ps0008 929
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Ps0008 945
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Ps0008 931
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ps0008 924
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ps0008 951
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ps0008 008
City
East Melbourne
Country
Australia
Facility Name
Ps0008 004
City
Fremantle
Country
Australia
Facility Name
Ps0008 007
City
Hectorville
Country
Australia
Facility Name
Ps0008 010
City
Kogarah
Country
Australia
Facility Name
Ps0008 005
City
Phillip
Country
Australia
Facility Name
Ps0008 009
City
Woolloongabba
Country
Australia
Facility Name
Ps0008 659
City
Calgary
Country
Canada
Facility Name
Ps0008 663
City
Mississauga
Country
Canada
Facility Name
Ps0008 660
City
Montréal
Country
Canada
Facility Name
Ps0008 661
City
Peterborough
Country
Canada
Facility Name
Ps0008 662
City
Toronto
Country
Canada
Facility Name
Ps0008 664
City
Toronto
Country
Canada
Facility Name
Ps0008 657
City
Waterloo
Country
Canada
Facility Name
Ps0008 669
City
Windsor
Country
Canada
Facility Name
Ps0008 670
City
Windsor
Country
Canada
Facility Name
Ps0008 674
City
Winnipeg
Country
Canada
Facility Name
Ps0008 207
City
Berlin
Country
Germany
Facility Name
Ps0008 218
City
Bonn
Country
Germany
Facility Name
Ps0008 203
City
Dresden
Country
Germany
Facility Name
Ps0008 211
City
Hamburg
Country
Germany
Facility Name
Ps0008 220
City
Hamburg
Country
Germany
Facility Name
Ps0008 215
City
Lubeck
Country
Germany
Facility Name
Ps0008 213
City
Mahlow
Country
Germany
Facility Name
Ps0008 205
City
Osnabrück
Country
Germany
Facility Name
Ps0008 217
City
Schweinfurt
Country
Germany
Facility Name
Ps0008 252
City
Budapest
Country
Hungary
Facility Name
Ps0008 254
City
Budapest
Country
Hungary
Facility Name
Ps0008 255
City
Budapest
Country
Hungary
Facility Name
Ps0008 256
City
Debrecen
Country
Hungary
Facility Name
Ps0008 251
City
Gyula
Country
Hungary
Facility Name
Ps0008 260
City
Szeged
Country
Hungary
Facility Name
Ps0008 702
City
Gwangju
Country
Korea, Republic of
Facility Name
Ps0008 700
City
Seoul
Country
Korea, Republic of
Facility Name
Ps0008 355
City
Białystok
Country
Poland
Facility Name
Ps0008 362
City
Białystok
Country
Poland
Facility Name
Ps0008 371
City
Bydgoszcz
Country
Poland
Facility Name
Ps0008 352
City
Gdańsk
Country
Poland
Facility Name
Ps0008 359
City
Katowice
Country
Poland
Facility Name
Ps0008 366
City
Katowice
Country
Poland
Facility Name
Ps0008 363
City
Kraków
Country
Poland
Facility Name
Ps0008 356
City
Lublin
Country
Poland
Facility Name
Ps0008 364
City
Nowa Sól
Country
Poland
Facility Name
Ps0008 353
City
Szczecin
Country
Poland
Facility Name
Ps0008 354
City
Warszawa
Country
Poland
Facility Name
Ps0008 365
City
Wrocław
Country
Poland
Facility Name
Ps0008 367
City
Wrocław
Country
Poland
Facility Name
Ps0008 373
City
Wrocław
Country
Poland
Facility Name
Ps0008 360
City
Łódź
Country
Poland
Facility Name
Ps0008 372
City
Łódź
Country
Poland
Facility Name
Ps0008 405
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ps0008 401
City
Saratov
Country
Russian Federation
Facility Name
Ps0008 406
City
Yaroslavl
Country
Russian Federation
Facility Name
Ps0008 754
City
Taipei
Country
Taiwan
Facility Name
Ps0008 755
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org
Citations:
PubMed Identifier
35544084
Citation
Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
Results Reference
result
PubMed Identifier
36689515
Citation
Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
Results Reference
result
PubMed Identifier
33891379
Citation
Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23.
Results Reference
derived
Links:
URL
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

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