Back to resultsA Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 2)
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Chronic plaque psoriasis, Psoriasis, Bimekizumab
Eligibility Criteria
Inclusion Criteria:
- Subject has provided informed consent
- Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011
Exclusion Criteria:
- Subject has previously participated in this study.
- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
- Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010
Sites / Locations
- Ps0011 708
- Ps0011 706
- Ps0011 704
- Ps0011 738
- Ps0011 712
- Ps0011 733
- Ps0011 709
- Ps0011 702
- Ps0011 209
- Ps0011 201
- Ps0011 206
- Ps0011 214
- Ps0011 203
- Ps0011 205
- Ps0011 300
- Ps0011 303
- Ps0011 301
- Ps0011 304
- Ps0011 404
- Ps0011 400
- Ps0011 405
- Ps0011 504
- Ps0011 503
- Ps0011 502
- Ps0011 501
- Ps0011 600
- Ps0011 603
- Ps0011 611
- Ps0011 610
- Ps0011 604
- Ps0011 608
- Ps0011 605
- Ps0011 606
- Ps0011 607
- Ps0011 601
- Ps0011 609
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Bimekizumab dosing regimen 1
Bimekizumab dosing regimen 2
Bimekizumab dosing regimen 3
Arm Description
Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
Secondary Outcome Measures
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03010527
Brief Title
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
Acronym
BE ABLE 2
Official Title
A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Chronic plaque psoriasis, Psoriasis, Bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
Arm Title
Bimekizumab dosing regimen 1
Arm Type
Experimental
Arm Description
Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
Arm Title
Bimekizumab dosing regimen 2
Arm Type
Experimental
Arm Description
Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
Arm Title
Bimekizumab dosing regimen 3
Arm Type
Experimental
Arm Description
Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Subjects will receive bimekizumab injections every four weeks (Q4W)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive Placebo injections every four weeks (Q4W)
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Description
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
Time Frame
From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
Description
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame
From Baseline during the Treatment Period (up to Week 48)
Title
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
Description
The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame
From Baseline during the Treatment Period (up to Week 48)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent
Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011
Exclusion Criteria:
Subject has previously participated in this study.
Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0011 708
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Ps0011 706
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Ps0011 704
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Ps0011 738
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Ps0011 712
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Ps0011 733
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ps0011 709
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ps0011 702
City
Houston
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Ps0011 209
City
Edmonton
Country
Canada
Facility Name
Ps0011 201
City
North Bay
Country
Canada
Facility Name
Ps0011 206
City
Peterborough
Country
Canada
Facility Name
Ps0011 214
City
Quebec City
Country
Canada
Facility Name
Ps0011 203
City
Surrey
Country
Canada
Facility Name
Ps0011 205
City
Waterloo
Country
Canada
Facility Name
Ps0011 300
City
Ostrava
Country
Czechia
Facility Name
Ps0011 303
City
Pardubice
Country
Czechia
Facility Name
Ps0011 301
City
Praha 10
Country
Czechia
Facility Name
Ps0011 304
City
Praha
Country
Czechia
Facility Name
Ps0011 404
City
Kecskemet
Country
Hungary
Facility Name
Ps0011 400
City
Oroshaza
Country
Hungary
Facility Name
Ps0011 405
City
Szekszard
Country
Hungary
Facility Name
Ps0011 504
City
Chiyoda-ku
Country
Japan
Facility Name
Ps0011 503
City
Minatoku
Country
Japan
Facility Name
Ps0011 502
City
Nagoya
Country
Japan
Facility Name
Ps0011 501
City
Shinagawa-ku
Country
Japan
Facility Name
Ps0011 600
City
Bialystok
Country
Poland
Facility Name
Ps0011 603
City
Bialystok
Country
Poland
Facility Name
Ps0011 611
City
Bialystok
Country
Poland
Facility Name
Ps0011 610
City
Gdynia
Country
Poland
Facility Name
Ps0011 604
City
Kielce
Country
Poland
Facility Name
Ps0011 608
City
Krakow
Country
Poland
Facility Name
Ps0011 605
City
Lublin
Country
Poland
Facility Name
Ps0011 606
City
Lublin
Country
Poland
Facility Name
Ps0011 607
City
Warszawa
Country
Poland
Facility Name
Ps0011 601
City
Wroclaw
Country
Poland
Facility Name
Ps0011 609
City
Wroclaw
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32473974
Citation
Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
Results Reference
result
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
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 Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
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