A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
BE VITAL
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
4 other identifiers
interventional
1,131
14 countries
138
Brief Summary
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2019
Longer than P75 for phase_3
138 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
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2026
April 13, 2026
April 1, 2026
6.8 years
July 2, 2019
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Incidence of treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary Outcomes (28)
TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Baseline of PA0010 or PA0011, Week 24 in PA0012
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Baseline of PA0010 or PA0011, Week 52 in PA0012
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Baseline of PA0010 or PA0011, Week 140 in PA0012
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Baseline of PA0010 or PA0011, Week 24 in PA0012
- +23 more secondary outcomes
Study Arms (1)
Bimekzumab dosage regimen
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Eligibility Criteria
You may qualify if:
- In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
- 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
You may not qualify if:
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
Pa0012 50017
Phoenix, Arizona, 85037, United States
Pa0012 50035
San Diego, California, 92128, United States
Pa0012 50033
Palm Harbor, Florida, 34684, United States
Pa0012 50037
Tampa, Florida, 33613, United States
Pa0012 50039
Atlanta, Georgia, 30342, United States
Pa0012 50024
Boise, Idaho, 83702, United States
Pa0012 50028
Lexington, Kentucky, 40504, United States
Pa0012 50023
Baton Rouge, Louisiana, 70836, United States
Pa0012 50015
Hagerstown, Maryland, 21740, United States
Pa0012 50047
Boston, Massachusetts, 02115-5817, United States
Pa0012 50019
Lansing, Michigan, 48911, United States
Pa0012 50016
St Louis, Missouri, 63141, United States
Pa0012 50005
Freehold, New Jersey, 07728, United States
Pa0012 50029
Albuquerque, New Mexico, 87102, United States
Pa0012 50010
Brooklyn, New York, 11201, United States
Pa0012 50011
New York, New York, 10029, United States
Pa0012 50034
Rochester, New York, 14642, United States
Pa0012 50125
Charlotte, North Carolina, 28211, United States
Pa0012 50031
Winston-Salem, North Carolina, 27104, United States
Pa0012 50040
Vandalia, Ohio, 45377, United States
Pa0012 50020
Duncansville, Pennsylvania, 16635, United States
Pa0012 50006
Wyomissing, Pennsylvania, 19610, United States
Pa0012 50008
Johnston, Rhode Island, 02919, United States
Pa0012 50007
Orangeburg, South Carolina, 29118, United States
Pa0012 50001
Jackson, Tennessee, 38305, United States
Pa0012 50012
Memphis, Tennessee, 38119-5214, United States
Pa0012 50002
Austin, Texas, 78731, United States
Pa0012 50049
Corpus Christi, Texas, 78404, United States
Pa0012 50036
Mesquite, Texas, 75150, United States
Pa0012 50009
Waco, Texas, 76710, United States
Pa0012 50050
Beckley, West Virginia, 25801, 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 am Main, 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
Related Publications (11)
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.
PMID: 39120849RESULTGossec 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.
PMID: 38754125RESULTKristensen 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.
PMID: 39534481RESULTMease 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.
PMID: 40347389RESULTThaci 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). 2026 Feb;16(2):953-976. doi: 10.1007/s13555-025-01599-5. Epub 2025 Dec 12.
PMID: 41381988RESULTGossec L, Coates LC, Landewe RBM, Mease PJ, Merola JF, Ritchlin CT, Tanaka Y, Asahina A, Proft F, Goldammer N, Manente M, Ink B, Bajracharya R, Coarse J, McInnes IB. Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies. Rheumatology (Oxford). 2026 Mar 16:keag118. doi: 10.1093/rheumatology/keag118. Online ahead of print.
PMID: 41838419DERIVEDMease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
PMID: 41807031DERIVEDMease 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: 40194794DERIVEDMease 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.
PMID: 39215949DERIVEDWarren 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.
PMID: 38488975DERIVEDMease 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.
PMID: 38446397DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
August 13, 2019
Primary Completion (Estimated)
May 25, 2026
Study Completion (Estimated)
May 25, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.