A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 2)

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: Bimekizumab

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada
    • Ps0011 209
  • North Bay, Canada
    • Ps0011 201
  • Peterborough, Canada
    • Ps0011 206
  • Quebec City, Canada
    • Ps0011 214
  • Surrey, Canada
    • Ps0011 203
  • Waterloo, Canada
    • Ps0011 205
• Czechia
  • Ostrava, Czechia
    • Ps0011 300
  • Pardubice, Czechia
    • Ps0011 303
  • Praha, Czechia
    • Ps0011 304
  • Praha 10, Czechia
    • Ps0011 301
• Hungary
  • Kecskemet, Hungary
    • Ps0011 404
  • Oroshaza, Hungary
    • Ps0011 400
  • Szekszard, Hungary
    • Ps0011 405
• Japan
  • Chiyoda-ku, Japan
    • Ps0011 504
  • Minatoku, Japan
    • Ps0011 503
  • Nagoya, Japan
    • Ps0011 502
  • Shinagawa-ku, Japan
    • Ps0011 501
• Poland
  • Bialystok, Poland
    • Ps0011 600
  • Bialystok, Poland
    • Ps0011 603
  • Bialystok, Poland
    • Ps0011 611
  • Gdynia, Poland
    • Ps0011 610
  • Kielce, Poland
    • Ps0011 604
  • Krakow, Poland
    • Ps0011 608
  • Lublin, Poland
    • Ps0011 605
  • Lublin, Poland
    • Ps0011 606
  • Warszawa, Poland
    • Ps0011 607
  • Wroclaw, Poland
    • Ps0011 601
  • Wroclaw, Poland
    • Ps0011 609
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Ps0011 708
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Ps0011 706
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Ps0011 704
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Ps0011 738
  • Oregon
    • Portland, Oregon, United States, 97223
      • Ps0011 712
  • Texas
    • Dallas, Texas, United States, 75231
      • Ps0011 733
    • Houston, Texas, United States, 77004
      • Ps0011 709
    • Houston, Texas, United States, 77598
      • Ps0011 702

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.	Other: Placebo; Subjects will receive Placebo injections every four weeks (Q4W)
Experimental: Bimekizumab dosing regimen 1; 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.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940
Experimental: Bimekizumab dosing regimen 2; 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.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940
Experimental: Bimekizumab dosing regimen 3; Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2016
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): September 25, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis; Chronic plaque psoriasis; Bimekizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PS0011; 2016-001892-57 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No