A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
BE OPTIMAL
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
2 other identifiers
interventional
852
14 countries
136
Brief Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active 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 Apr 2019
Typical duration for phase_3
136 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
March 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2022
CompletedResults Posted
Study results publicly available
October 23, 2024
CompletedJanuary 27, 2026
January 1, 2026
2.4 years
March 27, 2019
August 14, 2024
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter \[mm\] visual analog scale \[VAS\] \[0 = no symptoms;100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), Health Assessment Questionnaire-Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).
Week 16
Secondary Outcomes (19)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ
Baseline, Week 16
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline
Baseline, Week 4
Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline
Baseline, Week 16
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ
Baseline, Week 16
Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16
Week 16
- +14 more secondary outcomes
Study Arms (3)
Bimekzumab dosage regimen
EXPERIMENTALSubjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Adalimumab dosage regimen
ACTIVE COMPARATORSubjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Placebo
PLACEBO COMPARATORSubjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Adalimumab will be administered according to the labeling recommendations.
Subjects will receive placebo at pre-specified time-points.
Eligibility Criteria
You may qualify if:
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
- Subject is male or female at least 18 years of age
- Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
- 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
You may not qualify if:
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (136)
Pa0010 50017
Phoenix, Arizona, 85037, United States
Pa0010 50035
San Diego, California, 92025, United States
Pa0010 50004
Tustin, California, 92780, United States
Pa0010 50033
Palm Harbor, Florida, 34684, United States
Pa0010 50037
Tampa, Florida, 33613, United States
Pa0010 50039
Atlanta, Georgia, 30342, United States
Pa0010 50028
Lexington, Kentucky, 40504, United States
Pa0010 50015
Hagerstown, Maryland, 21742, United States
Pa0010 50016
St Louis, Missouri, 63141, United States
Pa0010 50029
Albuquerque, New Mexico, 87102, United States
Pa0010 50010
Brooklyn, New York, 11201, United States
Pa0010 50125
Charlotte, North Carolina, 28210, United States
Pa0010 50040
Dayton, Ohio, 45417, United States
Pa0010 50020
Duncansville, Pennsylvania, 16635, United States
Pa0010 50006
Wyomissing, Pennsylvania, 19610, United States
Pa0010 50008
Johnston, Rhode Island, 02919, United States
Pa0010 50007
Orangeburg, South Carolina, 29118, United States
Pa0010 50001
Jackson, Tennessee, 38305, United States
Pa0010 50012
Memphis, Tennessee, 38119, United States
Pa0010 50002
Austin, Texas, 78731, United States
Pa0010 50049
Corpus Christi, Texas, 78404, United States
Pa0010 50051
Houston, Texas, 77034, United States
Pa0010 50036
Mesquite, Texas, 75150, United States
Pa0010 50009
Waco, Texas, 76710, United States
Pa0010 50050
Beckley, West Virginia, 25801, United States
Pa0010 30005
Camberwell, Australia
Pa0010 30002
Clayton, Australia
Pa0010 30008
Hobart, Australia
Pa0010 30003
Maroochydore, Australia
Pa0010 30007
Victoria Park, Australia
Pa0010 30006
Woodville, Australia
Pa0010 40003
Genk, Belgium
Pa0010 40002
Leuven, Belgium
Pa0010 40059
Mons, Belgium
Pa0010 50041
Québec, Canada
Pa0010 50042
Rimouski, Canada
Pa0010 50043
Sidney, Canada
Pa0010 50044
Trois-Rivières, Canada
Pa0010 40061
Brno, Czechia
Pa0010 40065
Brno, Czechia
Pa0010 40062
Ostrava, Czechia
Pa0010 40009
Pardubice, Czechia
Pa0010 40013
Prague, Czechia
Pa0010 40014
Prague, Czechia
Pa0010 40015
Prague, Czechia
Pa0010 40063
Prague, Czechia
Pa0010 40066
Prague, Czechia
Pa0010 40010
Uherské Hradiště, Czechia
Pa0010 40012
Zlín, Czechia
Pa0010 40019
Paris, France
Pa0010 40068
Tours, France
Pa0010 40074
Bad Doberan, Germany
Pa0010 40025
Berlin, Germany
Pa0010 40028
Berlin, Germany
Pa0010 40076
Cottbus, Germany
Pa0010 40023
Erlangen, Germany
Pa0010 40117
Frankfurt, Germany
Pa0010 40029
Hamburg, Germany
Pa0010 40071
Hamburg, Germany
Pa0010 40027
Herne, Germany
Pa0010 40078
Leipzig, Germany
Pa0010 40348
Magdeburg, Germany
Pa0010 40026
Ratingen, Germany
Pa0010 40081
Budapest, Hungary
Pa0010 40083
Budapest, Hungary
Pa0010 40032
Debrecen, Hungary
Pa0010 40030
Eger, Hungary
Pa0010 40082
Kistarcsa, Hungary
Pa0010 40079
Szentes, Hungary
Pa0010 40033
Székesfehérvár, Hungary
Pa0010 40080
Szombathely, Hungary
Pa0010 40084
Catania, Italy
Pa0010 40087
Milan, Italy
Pa0010 40085
Pisa, Italy
Pa0010 40086
Reggio Emilia, Italy
Pa0010 20035
Bunkyō City, Japan
Pa0010 20036
Kawachi-Nagano-shi, Japan
Pa0010 20045
Kita-ku, Japan
Pa0010 20049
Kitakyushu, Japan
Pa0010 20044
Minatoku, Japan
Pa0010 20033
Nagoya, Japan
Pa0010 20041
Osaka, Japan
Pa0010 20046
Osaka, Japan
Pa0010 20048
Saitama, Japan
Pa0010 20031
Sapporo, Japan
Pa0010 20042
Sasebo, Japan
Pa0010 20032
Suita, Japan
Pa0010 20043
tabashi City, Japan
Pa0010 20030
Tokyo, Japan
Pa0010 40093
Bialystok, Poland
Pa0010 40119
Bydgoszcz, Poland
Pa0010 40038
Elblag, Poland
Pa0010 40088
Elblag, Poland
Pa0010 40096
Gdynia, Poland
Pa0010 40042
Krakow, Poland
Pa0010 40092
Krakow, Poland
Pa0010 40037
Lublin, Poland
Pa0010 40091
Nowa Sól, Poland
Pa0010 40044
Poznan, Poland
Pa0010 40090
Poznan, Poland
Pa0010 40118
Torun, Poland
Pa0010 40041
Warsaw, Poland
Pa0010 40094
Warsaw, Poland
Pa0010 40097
Warsaw, Poland
Pa0010 40098
Warsaw, Poland
Pa0010 40039
Wroclaw, Poland
Pa0010 40043
Wroclaw, Poland
Pa0010 40095
Wroclaw, Poland
Pa0010 20002
Moscow, Russia
Pa0010 20005
Moscow, Russia
Pa0010 20010
Moscow, Russia
Pa0010 20017
Moscow, Russia
Pa0010 20013
Petrozavodsk, Russia
Pa0010 20012
Ryazan, Russia
Pa0010 20016
Ryazan, Russia
Pa0010 20001
Saint Petersburg, Russia
Pa0010 20003
Saint Petersburg, Russia
Pa0010 20004
Saint Petersburg, Russia
Pa0010 20009
Saint Petersburg, Russia
Pa0010 20083
Saint Petersburg, Russia
Pa0010 20007
Saratov, Russia
Pa0010 20014
Ulyanovsk, Russia
Pa0010 20006
Vladimir, Russia
Pa0010 20008
Yaroslavl, Russia
Pa0010 20015
Yaroslavl, Russia
Pa0010 40045
A Coruña, Spain
Pa0010 40105
Córdoba, Spain
Pa0010 40102
Málaga, Spain
Pa0010 40101
Sabadell, Spain
Pa0010 40104
Santiago de Compostela, Spain
Pa0010 40049
Seville, Spain
Pa0010 40103
Seville, Spain
Pa0010 40106
Seville, Spain
Pa0010 40099
Vigo, Spain
Pa0010 40111
Leeds, United Kingdom
Pa0010 40107
Wolverhampton, United Kingdom
Related Publications (17)
Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Merola JF, Tanaka Y, Asahina A, Gossec L, Gottlieb AB, Warren RB, Ink B, Bajracharya R, Shende V, Coarse J, Landewe RB. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023 Nov;82(11):1404-1414. doi: 10.1136/ard-2023-224431. Epub 2023 Sep 11.
PMID: 37696588RESULTMease 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: 38446397RESULTKristensen 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: 40194794DERIVEDGladman 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.
PMID: 39892885DERIVEDHusni 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.
PMID: 39313302DERIVEDMease 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: 39215949DERIVEDMease 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: 39120849DERIVEDMease 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.
PMID: 39120848DERIVEDGossec 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: 38754125DERIVEDWarren 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: 38488975DERIVEDMaloney 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.
PMID: 38073049DERIVEDMcInnes IB, Asahina A, Coates LC, Landewe R, Merola JF, Ritchlin CT, Tanaka Y, Gossec L, Gottlieb AB, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Mease PJ. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023 Jan 7;401(10370):25-37. doi: 10.1016/S0140-6736(22)02302-9. Epub 2022 Dec 6.
PMID: 36493791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2019
First Posted
March 29, 2019
Study Start
April 3, 2019
Primary Completion
August 17, 2021
Study Completion
July 11, 2022
Last Updated
January 27, 2026
Results First Posted
October 23, 2024
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- 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 pre-specified 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.