A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
NCT ID: NCT03896581
Last Updated: 2026-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2019-03-28
2022-02-14
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
TRIPLE
Study Groups
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Bimekizumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects randomized to this arm will receive placebo.
Placebo
Subjects will receive placebo at pre-specified time-points.
Interventions
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Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects will receive placebo at pre-specified time-points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
* Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) \>=3 out of 68 and swollen joint count (SJC) \>=3 out of 66
* Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
* Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
* Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
* Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria
* Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
* Subject has an active infection or a history of recent serious infections
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
* Subject had acute anterior uveitis within 6 weeks of Baseline
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
* Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
* Presence of active suicidal ideation, or moderately severe major depression or severe major depression
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
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
001 844 599 2273 (UCB)
Locations
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Pa0011 50017
Phoenix, Arizona, United States
Pa0011 50035
San Diego, California, United States
Pa0011 50004
Tustin, California, United States
Pa0011 50033
Palm Harbor, Florida, United States
Pa0011 50037
Tampa, Florida, United States
Pa0011 50039
Atlanta, Georgia, United States
Pa0011 50024
Boise, Idaho, United States
Pa0011 50028
Lexington, Kentucky, United States
Pa0011 50023
Baton Rouge, Louisiana, United States
Pa0011 50015
Hagerstown, Maryland, United States
Pa0011 50026
Wheaton, Maryland, United States
Pa0011 50047
Boston, Massachusetts, United States
Pa0011 50019
Lansing, Michigan, United States
Pa0011 50016
St Louis, Missouri, United States
Pa0011 50005
Freehold, New Jersey, United States
Pa0011 50029
Albuquerque, New Mexico, United States
Pa0011 50010
Brooklyn, New York, United States
Pa0011 50011
New York, New York, United States
Pa0011 50034
Rochester, New York, United States
Pa0011 50125
Charlotte, North Carolina, United States
Pa0011 50031
Salisbury, North Carolina, United States
Pa0011 50040
Vandalia, Ohio, United States
Pa0011 50020
Duncansville, Pennsylvania, United States
Pa0011 50064
Philadelphia, Pennsylvania, United States
Pa0011 50006
Wyomissing, Pennsylvania, United States
Pa0011 50008
Johnston, Rhode Island, United States
Pa0011 50021
Summerville, South Carolina, United States
Pa0011 50001
Jackson, Tennessee, United States
Pa0011 50012
Memphis, Tennessee, United States
Pa0011 50002
Austin, Texas, United States
Pa0011 50036
Mesquite, Texas, United States
Pa0011 50009
Waco, Texas, United States
Pa0011 50050
Beckley, West Virginia, United States
Pa0011 30005
Camberwell, , Australia
Pa0011 30007
Victoria Park, , Australia
Pa0011 30006
Woodville South, , Australia
Pa0011 50042
Rimouski, , Canada
Pa0011 50043
Sydney, , Canada
Pa0011 50044
Trois-Rivières, , Canada
Pa0011 40009
Pardubice, , Czechia
Pa0011 40063
Prague, , Czechia
Pa0011 40066
Prague, , Czechia
Pa0011 40012
Zlín, , Czechia
Pa0011 40076
Cottbus, , Germany
Pa0011 40023
Erlangen, , Germany
Pa0011 40117
Frankfurt, , Germany
Pa0011 40029
Hamburg, , Germany
Pa0011 40071
Hamburg, , Germany
Pa0011 40078
Leipzig, , Germany
Pa0011 40026
Ratingen, , Germany
Pa0011 40083
Budapest, , Hungary
Pa0011 40079
Szentes, , Hungary
Pa0011 40084
Catania, , Italy
Pa0011 40087
Milan, , Italy
Pa0011 40086
Reggio Emilia, , Italy
Pa0011 20030
Chūōku, , Japan
Pa0011 20043
Itabashi-ku, , Japan
Pa0011 20036
Kawachi-Nagano, , Japan
Pa0011 20045
Kita-gun, , Japan
Pa0011 20049
Kitakyushu, , Japan
Pa0011 20044
Minatoku, , Japan
Pa0011 20041
Osaka, , Japan
Pa0011 20046
Osaka, , Japan
Pa0011 20031
Sapporo, , Japan
Pa0011 20042
Sasebo, , Japan
Pa0011 20032
Suita, , Japan
Pa0011 40119
Bydgoszcz, , Poland
Pa0011 40038
Elblag, , Poland
Pa0011 40037
Lublin, , Poland
Pa0011 40091
Nowa Sól, , Poland
Pa0011 40044
Poznan, , Poland
Pa0011 40090
Poznan, , Poland
Pa0011 40118
Torun, , Poland
Pa0011 40041
Warsaw, , Poland
Pa0011 40097
Warsaw, , Poland
Pa0011 40098
Warsaw, , Poland
Pa0011 40039
Wroclaw, , Poland
Pa0011 40043
Wroclaw, , Poland
Pa0011 20005
Korolyov, , Russia
Pa0011 20010
Moscow, , Russia
Pa0011 20013
Petrozavodsk, , Russia
Pa0011 20001
Saint Petersburg, , Russia
Pa0011 20004
Saint Petersburg, , Russia
Pa0011 20009
Saint Petersburg, , Russia
Pa0011 20007
Saratov, , Russia
Pa0011 20014
Ulyanovsk, , Russia
Pa0011 20006
Vladimir, , Russia
Pa0011 20008
Yaroslavl, , Russia
Pa0011 20015
Yaroslavl, , Russia
Pa0011 40111
Bradford, , United Kingdom
Pa0011 40109
Oxford, , United Kingdom
Pa0011 40116
Stamford, , United Kingdom
Countries
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References
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Warren RB, McInnes IB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, Mease PJ. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.
Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 Aug;12(4):609-612. doi: 10.1007/s40744-025-00764-8. Epub 2025 May 10.
Thaci D, Asahina A, Boehncke WH, Gottlieb AB, Lebwohl M, Warren RB, Edens H, Ink B, Bajracharya R, Coarse J, Merola JF. Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. Dermatol Ther (Heidelb). 2025 Dec 12. doi: 10.1007/s13555-025-01599-5. Online ahead of print.
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.
Gladman DD, Mease PJ, Gossec L, Husni ME, Gottlieb AB, Ink B, Bajracharya R, Coarse J, Lyris N, Lambert J, Tillett W. Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies. J Rheumatol. 2025 May 1;52(5):466-478. doi: 10.3899/jrheum.2024-0923.
Husni ME, Mease PJ, Merola JF, Tillett W, Goldammer N, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. RMD Open. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.
Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024 Oct;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Epub 2024 Aug 31.
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.
Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.
Maloney A, Dua P, Ahmed GF. Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model-Based Meta-Analysis of American College of Rheumatology Response Criteria. Clin Pharmacol Ther. 2024 May;115(5):1007-1014. doi: 10.1002/cpt.3135. Epub 2024 Jan 12.
Merola JF, Landewe R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asahina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Thaci D, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Coates LC. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-alpha inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023 Jan 7;401(10370):38-48. doi: 10.1016/S0140-6736(22)02303-0. Epub 2022 Dec 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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PA0011
Identifier Type: -
Identifier Source: org_study_id
2017-002804-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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