A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
NCT ID: NCT03347110
Last Updated: 2023-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2017-11-22
2020-10-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bimekizumab
Subjects will receive bimekizumab up to 2 years.
Bimekizumab
Bimekizumab at a prespecified dose.
Interventions
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Bimekizumab
Bimekizumab at a prespecified dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject completed PA0008 without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Exclusion Criteria
* Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
* Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 8445992273 (UCB)
Locations
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Pa0009 025
Lexington, Kentucky, United States
Pa0009 003
Hagerstown, Maryland, United States
Pa0009 011
Lansing, Michigan, United States
Pa0009 028
Rochester, New York, United States
Pa0009 014
Portland, Oregon, United States
Pa0009 001
Duncansville, Pennsylvania, United States
Pa0009 012
Johnston, Rhode Island, United States
Pa0009 004
Charleston, South Carolina, United States
Pa0009 010
Jackson, Tennessee, United States
Pa0009 006
Dallas, Texas, United States
Pa0009 013
Mesquite, Texas, United States
Pa0009 205
Brno, , Czechia
Pa0009 207
Olomouc, , Czechia
Pa0009 201
Prague, , Czechia
Pa0009 202
Prague, , Czechia
Pa0009 210
Prague, , Czechia
Pa0009 203
Zlín, , Czechia
Pa0009 302
Cologne, , Germany
Pa0009 309
Erlangen, , Germany
Pa0009 304
Hamburg, , Germany
Pa0009 301
Ratingen, , Germany
Pa0009 403
Budapest, , Hungary
Pa0009 401
Veszprém, , Hungary
Pa0009 452
Bialystok, , Poland
Pa0009 453
Elblag, , Poland
Pa0009 456
Elblag, , Poland
Pa0009 455
Krakow, , Poland
Pa0009 451
Poznan, , Poland
Pa0009 450
Torun, , Poland
Pa0009 454
Warsaw, , Poland
Pa0009 459
Warsaw, , Poland
Pa0009 465
Wroclaw, , Poland
Pa0009 604
Moscow, , Russia
Pa0009 605
Moscow, , Russia
Pa0009 607
Moscow, , Russia
Pa0009 606
Saint Petersburg, , Russia
Pa0009 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.
Coates LC, McInnes IB, Merola JF, Warren RB, Kavanaugh A, Gottlieb AB, Gossec L, Assudani D, Bajracharya R, Coarse J, Ink B, Ritchlin CT. Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1959-1970. doi: 10.1002/art.42280. Epub 2022 Nov 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001003-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PA0009
Identifier Type: -
Identifier Source: org_study_id