A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
NCT ID: NCT04009499
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1131 participants
INTERVENTIONAL
2019-08-13
2026-05-25
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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Bimekzumab dosage regimen
Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Interventions
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Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Exclusion Criteria
* Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
* Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
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
Locations
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Pa0012 50017
Phoenix, Arizona, United States
Pa0012 50035
San Diego, California, United States
Pa0012 50033
Palm Harbor, Florida, United States
Pa0012 50037
Tampa, Florida, United States
Pa0012 50039
Atlanta, Georgia, United States
Pa0012 50024
Boise, Idaho, United States
Pa0012 50028
Lexington, Kentucky, United States
Pa0012 50023
Baton Rouge, Louisiana, United States
Pa0012 50015
Hagerstown, Maryland, United States
Pa0012 50047
Boston, Massachusetts, United States
Pa0012 50019
Lansing, Michigan, United States
Pa0012 50016
St Louis, Missouri, United States
Pa0012 50005
Freehold, New Jersey, United States
Pa0012 50029
Albuquerque, New Mexico, United States
Pa0012 50010
Brooklyn, New York, United States
Pa0012 50011
New York, New York, United States
Pa0012 50034
Rochester, New York, United States
Pa0012 50125
Charlotte, North Carolina, United States
Pa0012 50031
Salisbury, North Carolina, United States
Pa0012 50040
Vandalia, Ohio, United States
Pa0012 50020
Duncansville, Pennsylvania, United States
Pa0012 50006
Wyomissing, Pennsylvania, United States
Pa0012 50008
Johnston, Rhode Island, United States
Pa0012 50007
Orangeburg, South Carolina, United States
Pa0012 50001
Jackson, Tennessee, United States
Pa0012 50012
Memphis, Tennessee, United States
Pa0012 50002
Austin, Texas, United States
Pa0012 50049
Corpus Christi, Texas, United States
Pa0012 50036
Mesquite, Texas, United States
Pa0012 50009
Waco, Texas, United States
Pa0012 50050
Beckley, West Virginia, United States
Pa0012 30005
Camberwell, , Australia
Pa0012 30002
Clayton, , Australia
Pa0012 30008
Hobart, , Australia
Pa0012 30003
Maroochydore, , Australia
Pa0012 30007
Victoria Park, , Australia
Pa0012 30006
Woodville South, , Australia
Pa0012 40003
Genk, , Belgium
Pa0012 40002
Leuven, , Belgium
Pa0012 40059
Mons, , Belgium
Pa0012 50041
Québec, , Canada
Pa0012 50042
Rimouski, , Canada
Pa0012 50043
Sydney, , Canada
Pa0012 50044
Trois-Rivières, , Canada
Pa0012 40061
Brno, , Czechia
Pa0012 40065
Brno, , Czechia
Pa0012 40062
Moravska Ostrava A Privoz, , Czechia
Pa0012 40009
Pardubice, , Czechia
Pa0012 40013
Prague, , Czechia
Pa0012 40014
Prague, , Czechia
Pa0012 40015
Prague, , Czechia
Pa0012 40063
Prague, , Czechia
Pa0012 40066
Prague, , Czechia
Pa0012 40010
Uherské Hradiště, , Czechia
Pa0012 40012
Zlín, , Czechia
Pa0012 40068
Chambray-lès-Tours, , France
Pa0012 40019
Paris, , France
Pa0012 40074
Bad Doberan, , Germany
Pa0012 40025
Berlin, , Germany
Pa0012 40076
Cottbus, , Germany
Pa0012 40023
Erlangen, , Germany
Pa0012 40117
Frankfurt, , Germany
Pa0012 40029
Hamburg, , Germany
Pa0012 40071
Hamburg, , Germany
Pa0012 40027
Herne, , Germany
Pa0012 40078
Leipzig, , Germany
Pa0012 40026
Ratingen, , Germany
Pa0012 40081
Budapest, , Hungary
Pa0012 40083
Budapest, , Hungary
Pa0012 40032
Debrecen, , Hungary
Pa0012 40030
Eger, , Hungary
Pa0012 40082
Kistarcsa, , Hungary
Pa0012 40079
Szentes, , Hungary
Pa0012 40033
Székesfehérvár, , Hungary
Pa0012 40084
Catania, , Italy
Pa0012 40087
Milan, , Italy
Pa0012 40086
Reggio Emilia, , Italy
Pa0012 20035
Bunkyō City, , Japan
Pa0012 20030
Chūōku, , Japan
Pa0012 20043
Itabashi-ku, , Japan
Pa0012 20036
Kawachi-Nagano, , Japan
Pa0012 20045
Kita-gun, , Japan
Pa0012 20049
Kitakyushu, , Japan
Pa0012 20044
Minatoku, , Japan
Pa0012 20033
Nagoya, , Japan
Pa0012 20041
Osaka, , Japan
Pa0012 20046
Osaka, , Japan
Pa0012 20048
Saitama, , Japan
Pa0012 20031
Sapporo, , Japan
Pa0012 20042
Sasebo, , Japan
Pa0012 20032
Suita, , Japan
Pa0012 40093
Bialystok, , Poland
Pa0012 40119
Bydgoszcz, , Poland
Pa0012 40038
Elblag, , Poland
Pa0012 40088
Elblag, , Poland
Pa0012 40096
Gdynia, , Poland
Pa0012 40042
Krakow, , Poland
Pa0012 40092
Krakow, , Poland
Pa0012 40037
Lublin, , Poland
Pa0012 40091
Nowa Sól, , Poland
Pa0012 40044
Poznan, , Poland
Pa0012 40090
Poznan, , Poland
Pa0012 40041
Warsaw, , Poland
Pa0012 40094
Warsaw, , Poland
Pa0012 40097
Warsaw, , Poland
Pa0012 40098
Warsaw, , Poland
Pa0012 40118
Warsaw, , Poland
Pa0012 40039
Wroclaw, , Poland
Pa0012 40043
Wroclaw, , Poland
Pa0012 40095
Wroclaw, , Poland
Pa0012 20002
Moscow, , Russia
Pa0012 20005
Moscow, , Russia
Pa0012 20010
Moscow, , Russia
Pa0012 20017
Moscow, , Russia
Pa0012 20013
Petrozavodsk, , Russia
Pa0012 20012
Ryazan, , Russia
Pa0012 20016
Ryazan, , Russia
Pa0012 20001
Saint Petersburg, , Russia
Pa0012 20003
Saint Petersburg, , Russia
Pa0012 20004
Saint Petersburg, , Russia
Pa0012 20009
Saint Petersburg, , Russia
Pa0012 20083
Saint Petersburg, , Russia
Pa0012 20007
Saratov, , Russia
Pa0012 20014
Ulyanovsk, , Russia
Pa0012 20006
Vladimir, , Russia
Pa0012 20008
Yaroslavl, , Russia
Pa0012 20015
Yaroslavl, , Russia
Pa0012 40045
A Coruña, , Spain
Pa0012 40105
Córdoba, , Spain
Pa0012 40102
Málaga, , Spain
Pa0012 40101
Sabadell, , Spain
Pa0012 40104
Santiago de Compostela, , Spain
Pa0012 40049
Seville, , Spain
Pa0012 40106
Seville, , Spain
Pa0012 40099
Vigo, , Spain
Pa0012 40109
Oxford, , United Kingdom
Pa0012 40116
Peterborough, , United Kingdom
Pa0012 40107
Wolverhampton, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2018-004725-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506528-95
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1304-6874
Identifier Type: OTHER
Identifier Source: secondary_id
PA0012
Identifier Type: -
Identifier Source: org_study_id