A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010527
• Other study ID #: PS0011
• Secondary ID: 2016-001892-57
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2016
• Est. completion date: September 25, 2018

Study information

• Verified date: September 2022
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab injections every four weeks (Q4W)

Other:
• Placebo
Subjects will receive Placebo injections every four weeks (Q4W)

Locations

Country	Name	City	State
Canada	Ps0011 209	Edmonton
Canada	Ps0011 201	North Bay
Canada	Ps0011 206	Peterborough
Canada	Ps0011 214	Quebec City
Canada	Ps0011 203	Surrey
Canada	Ps0011 205	Waterloo
Czechia	Ps0011 300	Ostrava
Czechia	Ps0011 303	Pardubice
Czechia	Ps0011 304	Praha
Czechia	Ps0011 301	Praha 10
Hungary	Ps0011 404	Kecskemet
Hungary	Ps0011 400	Oroshaza
Hungary	Ps0011 405	Szekszard
Japan	Ps0011 504	Chiyoda-ku
Japan	Ps0011 503	Minatoku
Japan	Ps0011 502	Nagoya
Japan	Ps0011 501	Shinagawa-ku
Poland	Ps0011 600	Bialystok
Poland	Ps0011 603	Bialystok
Poland	Ps0011 611	Bialystok
Poland	Ps0011 610	Gdynia
Poland	Ps0011 604	Kielce
Poland	Ps0011 608	Krakow
Poland	Ps0011 605	Lublin
Poland	Ps0011 606	Lublin
Poland	Ps0011 607	Warszawa
Poland	Ps0011 601	Wroclaw
Poland	Ps0011 609	Wroclaw
United States	Ps0011 733	Dallas	Texas
United States	Ps0011 702	Houston	Texas
United States	Ps0011 709	Houston	Texas
United States	Ps0011 708	Los Angeles	California
United States	Ps0011 712	Portland	Oregon
United States	Ps0011 706	Washington	District of Columbia
United States	Ps0011 704	West Des Moines	Iowa
United States	Ps0011 738	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Hungary,  Japan,  Poland, 

References & Publications (2)

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 — View Citation

Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaçi D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary	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.	From Baseline during the Treatment Period (up to Week 48)
Secondary	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.	From Baseline during the Treatment Period (up to Week 48)

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