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A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE RADIANT)

Primary Purpose

Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Secukinumab
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:

Double-blind Treatment Period

  • Male or female at least 18 years of age
  • Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
  • Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
  • Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
  • Female subject of childbearing potential must be willing to use highly effective method of contraception

Open-label extension (OLE) Period

  • Completed the double-blind Treatment Period without meeting any withdrawal criteria
  • All Week 48 visit assessments completed
  • Compliant with ongoing clinical study requirements
  • Signed a separate OLE Period Informed Consent Form (ICF)
  • Female subject of childbearing potential must be willing to use highly effective method of contraception

OLE2 Period (USA and Canada)

  • Completed the OLE Period without meeting any withdrawal criteria
  • Compliant with ongoing clinical study requirements
  • Female subject of childbearing potential must be willing to use highly effective method of contraception
  • Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
  • Signed a separate OLE2 Period ICF

Exclusion Criteria:

Double-blind Treatment Period

  • Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or 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
  • Presence of active suicidal ideation or severe 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

OLE2 Period (USA and Canada)

  • Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
  • Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
  • Presence of active suicidal ideation or severe depression
  • Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Sites / Locations

  • Ps0015 975
  • Ps0015 939
  • Ps0015 903
  • Ps0015 921
  • Ps0015 977
  • Ps0015 936
  • Ps0015 976
  • Ps0015 970
  • Ps0015 966
  • Ps0015 954
  • Ps0015 972
  • Ps0015 900
  • Ps0015 944
  • Ps0015 915
  • Ps0015 953
  • Ps0015 901
  • Ps0015 965
  • Ps0015 969
  • Ps0015 971
  • Ps0015 980
  • Ps0015 920
  • Ps0015 929
  • Ps0015 979
  • Ps0015 924
  • Ps0015 978
  • PS0015 3
  • PS0015 7
  • PS0015 6
  • Ps0015 11
  • PS0015 9
  • Ps0015 54
  • Ps0015 50
  • Ps0015 52
  • Ps0015 673
  • Ps0015 671
  • Ps0015 663
  • Ps0015 661
  • Ps0015 678
  • Ps0015 677
  • Ps0015 657
  • Ps0015 153
  • Ps0015 223
  • Ps0015 237
  • Ps0015 211
  • Ps0015 215
  • Ps0015 213
  • Ps0015 238
  • Ps0015 234
  • Ps0015 219
  • Ps0015 236
  • Ps0015 222
  • Ps0015 204
  • Ps0015 265
  • Ps0015 263
  • Ps0015 355
  • Ps0015 361
  • Ps0015 369
  • Ps0015 352
  • Ps0015 366
  • Ps0015 378
  • Ps0015 376
  • Ps0015 379
  • Ps0015 372
  • Ps0015 377
  • Ps0015 368
  • Ps0015 375
  • Ps0015 455
  • Ps0015 450
  • Ps0015 451
  • Ps0015 454
  • Ps0015 456
  • Ps0015 457
  • Ps0015 763
  • Ps0015 762
  • Ps0015 760
  • Ps0015 559
  • Ps0015 555

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Bimekizumab dosage regimen 1

Bimekizumab dosage regimen 2

Secukinumab

Arm Description

Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1). At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2). Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2). Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
The PASI100 response assessments are based on 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.

Secondary Outcome Measures

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 score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 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 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 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 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 48
The PASI100 response assessments are based on 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 Investigator´s Global Assessment (IGA) Response (0/1) 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.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48
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 IMP From Baseline up to Week 48
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 TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
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
May 14, 2018
Last Updated
September 20, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03536884
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE RADIANT
Official Title
A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study 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
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
August 9, 2023 (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 secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
Detailed Description
The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

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 Chronic 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
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimekizumab dosage regimen 1
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1). At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2). Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Arm Title
Bimekizumab dosage regimen 2
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Arm Title
Secukinumab
Arm Type
Active Comparator
Arm Description
Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2). Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
COSENTYX®
Intervention Description
Subjects will receive secukinumab at pre-specified time-points.
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 in the double-blind Treatment Period.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
Description
The PASI100 response assessments are based on 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
Secondary Outcome Measure Information:
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 score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 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 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 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 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 48
Description
The PASI100 response assessments are based on 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 48
Title
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) 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
Title
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48
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 up to Week 48
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
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 up to Week 48
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
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 up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Double-blind Treatment Period Male or female at least 18 years of age Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label Female subject of childbearing potential must be willing to use highly effective method of contraception Open-label extension (OLE) Period Completed the double-blind Treatment Period without meeting any withdrawal criteria All Week 48 visit assessments completed Compliant with ongoing clinical study requirements Signed a separate OLE Period Informed Consent Form (ICF) Female subject of childbearing potential must be willing to use highly effective method of contraception OLE2 Period (USA and Canada) Completed the OLE Period without meeting any withdrawal criteria Compliant with ongoing clinical study requirements Female subject of childbearing potential must be willing to use highly effective method of contraception Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only) Signed a separate OLE2 Period ICF Exclusion Criteria: Double-blind Treatment Period Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or 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 Presence of active suicidal ideation or severe 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 OLE2 Period (USA and Canada) Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated Presence of active suicidal ideation or severe depression Subject has developed any active malignancy or history of malignancy prior to the OLE2 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
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Ps0015 975
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Ps0015 939
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Ps0015 903
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Ps0015 921
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Ps0015 977
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Ps0015 936
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Ps0015 976
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Ps0015 970
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Ps0015 966
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Ps0015 954
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Ps0015 972
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Ps0015 900
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Ps0015 944
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ps0015 915
City
Clayton
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States
Facility Name
Ps0015 953
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Ps0015 901
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Ps0015 965
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Ps0015 969
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Ps0015 971
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Ps0015 980
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Ps0015 920
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Ps0015 929
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Ps0015 979
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Ps0015 924
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ps0015 978
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
PS0015 3
City
Carlton
Country
Australia
Facility Name
PS0015 7
City
Hectorville
Country
Australia
Facility Name
PS0015 6
City
Kogarah
Country
Australia
Facility Name
Ps0015 11
City
Parkville
Country
Australia
Facility Name
PS0015 9
City
Woolloongabba
Country
Australia
Facility Name
Ps0015 54
City
Brussels
Country
Belgium
Facility Name
Ps0015 50
City
Bruxelles
Country
Belgium
Facility Name
Ps0015 52
City
Liege
Country
Belgium
Facility Name
Ps0015 673
City
Halifax
Country
Canada
Facility Name
Ps0015 671
City
Hamilton
Country
Canada
Facility Name
Ps0015 663
City
Mississauga
Country
Canada
Facility Name
Ps0015 661
City
Peterborough
Country
Canada
Facility Name
Ps0015 678
City
Richmond Hill
Country
Canada
Facility Name
Ps0015 677
City
Toronto
Country
Canada
Facility Name
Ps0015 657
City
Waterloo
Country
Canada
Facility Name
Ps0015 153
City
Toulouse
Country
France
Facility Name
Ps0015 223
City
Augsburg
Country
Germany
Facility Name
Ps0015 237
City
Berlin
Country
Germany
Facility Name
Ps0015 211
City
Hamburg
Country
Germany
Facility Name
Ps0015 215
City
Lübeck
Country
Germany
Facility Name
Ps0015 213
City
Mahlow
Country
Germany
Facility Name
Ps0015 238
City
Mainz
Country
Germany
Facility Name
Ps0015 234
City
München
Country
Germany
Facility Name
Ps0015 219
City
Münster
Country
Germany
Facility Name
Ps0015 236
City
Neu-ulm
Country
Germany
Facility Name
Ps0015 222
City
Tuebingen
Country
Germany
Facility Name
Ps0015 204
City
Witten
Country
Germany
Facility Name
Ps0015 265
City
Amsterdam
Country
Netherlands
Facility Name
Ps0015 263
City
Breda
Country
Netherlands
Facility Name
Ps0015 355
City
Bialystok
Country
Poland
Facility Name
Ps0015 361
City
Bialystok
Country
Poland
Facility Name
Ps0015 369
City
Bialystok
Country
Poland
Facility Name
Ps0015 352
City
Gdansk
Country
Poland
Facility Name
Ps0015 366
City
Katowice
Country
Poland
Facility Name
Ps0015 378
City
Katowice
Country
Poland
Facility Name
Ps0015 376
City
Krakow
Country
Poland
Facility Name
Ps0015 379
City
Krakow
Country
Poland
Facility Name
Ps0015 372
City
Lodz
Country
Poland
Facility Name
Ps0015 377
City
Ostrowiec Swietokrzyski
Country
Poland
Facility Name
Ps0015 368
City
Wroclaw
Country
Poland
Facility Name
Ps0015 375
City
Wroclaw
Country
Poland
Facility Name
Ps0015 455
City
Alicante
Country
Spain
Facility Name
Ps0015 450
City
Barcelona
Country
Spain
Facility Name
Ps0015 451
City
Madrid
Country
Spain
Facility Name
Ps0015 454
City
Madrid
Country
Spain
Facility Name
Ps0015 456
City
Madrid
Country
Spain
Facility Name
Ps0015 457
City
Sant Joan Despí
Country
Spain
Facility Name
Ps0015 763
City
Gaziantep
Country
Turkey
Facility Name
Ps0015 762
City
Istanbul
Country
Turkey
Facility Name
Ps0015 760
City
Kayseri
Country
Turkey
Facility Name
Ps0015 559
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Ps0015 555
City
Salford
Country
United Kingdom

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
https://www.Vivli.org
Citations:
PubMed Identifier
37182701
Citation
Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.
Results Reference
result
PubMed Identifier
34471992
Citation
Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.
Results Reference
derived
PubMed Identifier
34001692
Citation
Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.
Results Reference
derived
PubMed Identifier
33891380
Citation
Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
Description
Product Information

Learn more about this trial

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

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