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
NCT ID: NCT02969525
Last Updated: 2023-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
206 participants
INTERVENTIONAL
2016-10-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Subjects 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.
Placebo
Bimekizumab dosage regimen 1
Subjects 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
Bimekizumab in different dosage regimens.
Bimekizumab dosage regimen 2
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Bimekizumab
Bimekizumab in different dosage regimens.
Bimekizumab dosage regimen 3
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Bimekizumab
Bimekizumab in different dosage regimens.
Bimekizumab dosage regimen 4
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Bimekizumab
Bimekizumab in different dosage regimens.
Interventions
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Placebo
Bimekizumab
Bimekizumab in different dosage regimens.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. experienced an inadequate response to previous treatment given for at least 3 months
2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
3. lost access to TNF inhibitor for other reasons
Exclusion Criteria
* 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:
1. \<= 3 excised or ablated basal cell carcinomas of the skin
2. 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
3. Actinic keratosis (-es)
4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273(UCB)
Locations
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Pa0008 007
San Diego, California, United States
Pa0008 005
Aventura, Florida, United States
Pa0008 003
Hagerstown, Maryland, United States
Pa0008 011
Lansing, Minnesota, United States
Pa0008 025
Lexington, New York, United States
Pa0008 014
Portland, Oregon, United States
Pa0008 001
Duncansville, Pennsylvania, United States
Pa0008 012
Johnston, Rhode Island, United States
Pa0008 004
Charleston, South Carolina, United States
Pa0008 010
Jackson, Tennessee, United States
Pa0008 006
Dallas, Texas, United States
Pa0008 013
Mesquite, Texas, United States
Pa0008 002
Seattle, Washington, 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
Countries
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References
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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.
Mease 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.
Ritchlin 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001103-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PA0008
Identifier Type: -
Identifier Source: org_study_id
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