A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
BE ACTIVE
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
2 other identifiers
interventional
206
6 countries
40
Brief Summary
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
November 25, 2020
CompletedMarch 20, 2023
March 1, 2023
1.1 years
November 10, 2016
October 30, 2020
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Week 12
Secondary Outcomes (26)
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
Week 12
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
Week 12
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
Week 12
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
Week 12
Percentage of Participants With at Least One Adverse Event (AE) During the Study
From Screening Period until the Safety Follow-Up Visit (up to Week 72)
- +21 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORSubjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Bimekizumab dosage regimen 1
EXPERIMENTALSubjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Bimekizumab dosage regimen 2
EXPERIMENTALSubjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Bimekizumab dosage regimen 3
EXPERIMENTALSubjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Bimekizumab dosage regimen 4
EXPERIMENTALSubjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Interventions
Bimekizumab in different dosage regimens.
Eligibility Criteria
You may qualify if:
- Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) \>=3 out of 78 and swollen joint count (SJC) \>=3 out of 76
- Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
- Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
- Subjects taking corticosteroids must be on an average daily dose of \<=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
- Subjects taking methotrexate (MTX) (\<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
- Subjects taking leflunomide (LEF; \<=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
- Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
- experienced an inadequate response to previous treatment given for at least 3 months
- been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
- lost access to TNF inhibitor for other reasons
You may not qualify if:
- Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
- Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
- Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
- \<= 3 excised or ablated basal cell carcinomas of the skin
- One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
- Actinic keratosis (-es)
- Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Pa0008 007
San Diego, California, 92037, United States
Pa0008 005
Aventura, Florida, 33180, United States
Pa0008 003
Hagerstown, Maryland, 21740, United States
Pa0008 011
Lansing, Minnesota, 48910, United States
Pa0008 025
Lexington, New York, 40504, United States
Pa0008 014
Portland, Oregon, 97239, United States
Pa0008 001
Duncansville, Pennsylvania, 16635, United States
Pa0008 012
Johnston, Rhode Island, 02919, United States
Pa0008 004
Charleston, South Carolina, 29406-93, United States
Pa0008 010
Jackson, Tennessee, 38305, United States
Pa0008 006
Dallas, Texas, 75231, United States
Pa0008 013
Mesquite, Texas, 75150, United States
Pa0008 002
Seattle, Washington, 98122, United States
Pa0008 205
Brno, Czechia
Pa0008 207
Olomouc, Czechia
Pa0008 201
Prague, Czechia
Pa0008 202
Prague, Czechia
Pa0008 209
Prague, Czechia
Pa0008 210
Prague, Czechia
Pa0008 203
Zlín, Czechia
Pa0008 302
Cologne, Germany
Pa0008 309
Erlangen, Germany
Pa0008 304
Hamburg, Germany
Pa0008 301
Ratingen, Germany
Pa0008 403
Budakeszierdő, Hungary
Pa0008 401
Veszprém, Hungary
Pa0008 452
Bialystok, Poland
Pa0008 453
Elblag, Poland
Pa0008 456
Elblag, Poland
Pa0008 455
Krakow, Poland
Pa0008 451
Poznan, Poland
Pa0008 450
Torun, Poland
Pa0008 454
Warsaw, Poland
Pa0008 459
Warsaw, Poland
Pa0008 465
Wroclaw, Poland
Pa0008 604
Moscow, Russia
Pa0008 605
Moscow, Russia
Pa0008 607
Moscow, Russia
Pa0008 606
Saint Petersburg, Russia
Pa0008 608
Saint Petersburg, Russia
Related Publications (3)
Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.
PMID: 35789257RESULTMease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
PMID: 40194794DERIVEDRitchlin CT, Kavanaugh A, Merola JF, Schett G, Scher JU, Warren RB, Gottlieb AB, Assudani D, Bedford-Rice K, Coarse J, Ink B, McInnes IB. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020 Feb 8;395(10222):427-440. doi: 10.1016/S0140-6736(19)33161-7.
PMID: 32035552DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Biomarker assays were not rigorously validated, thus it was not possible to use results for PD as a secondary objective. The results were interpreted with caution for exploratory purpose, and thus are not shared in this report.
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273(UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 21, 2016
Study Start
October 1, 2016
Primary Completion
November 1, 2017
Study Completion
July 1, 2018
Last Updated
March 20, 2023
Results First Posted
November 25, 2020
Record last verified: 2023-03