A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
NCT ID: NCT03928704
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2019-04-25
2023-04-17
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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimekizumab
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.
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 during the Double-Blind Treatment Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
1. Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
2. Inflammatory back pain for at least 3 months
3. Age at symptom onset of less than 45 years
4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
* Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale
* Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein
* Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
* Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
* Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, 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
* Active infection or history of recent serious infections
* Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
* Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
* 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
* Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients 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 when entering the study
* Presence of active suicidal ideation, or moderately severe major depression or severe major depression
* Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
* 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
Locations
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As0010 50131
Mesa, Arizona, United States
As0010 50052
Phoenix, Arizona, United States
As0010 50062
Sun City, Arizona, United States
As0010 50060
Upland, California, United States
As0010 50059
Ormond Beach, Florida, United States
As0010 50056
Sarasota, Florida, United States
As0010 50015
Hagerstown, Maryland, United States
As0010 50016
St Louis, Missouri, United States
As0010 50055
Portland, Oregon, United States
As0010 50020
Duncansville, Pennsylvania, United States
As0010 50012
Memphis, Tennessee, United States
As0010 50057
Dallas, Texas, United States
As0010 50036
Mesquite, Texas, United States
As0010 50061
Spokane, Washington, United States
As0010 40004
Brussels, , Belgium
As0010 40003
Genk, , Belgium
As0010 40001
Ghent, , Belgium
As0010 40002
Merksem, , Belgium
As0010 40006
Plovdiv, , Bulgaria
As0010 40007
Plovdiv, , Bulgaria
As0010 40005
Sofia, , Bulgaria
As0010 40008
Sofia, , Bulgaria
As0010 20040
Beijing, , China
As0010 20021
Chengdu, , China
As0010 20019
Guangzhou, , China
As0010 20034
Hefei, , China
As0010 20024
Nanjing, , China
As0010 20018
Shanghai, , China
As0010 20020
Shanghai, , China
As0010 20026
Shanghai, , China
As0010 20025
Wenzhou, , China
As0010 40011
Brno, , Czechia
As0010 40009
Pardubice, , Czechia
As0010 40013
Prague, , Czechia
As0010 40014
Prague, , Czechia
As0010 40015
Prague, , Czechia
As0010 40016
Prague, , Czechia
As0010 40010
Uherské Hradiště, , Czechia
As0010 40012
Zlín, , Czechia
As0010 40018
Boulogne-Billancourt, , France
As0010 40022
Limoges, , France
As0010 40025
Berlin, , Germany
As0010 40029
Hamburg, , Germany
As0010 40024
Hanover, , Germany
As0010 40027
Herne, , Germany
As0010 40078
Leipzig, , Germany
As0010 40026
Ratingen, , Germany
As0010 40032
Debrecen, , Hungary
As0010 40031
Szeged, , Hungary
As0010 40033
Székesfehérvár, , Hungary
As0010 40080
Szombathely, , Hungary
As0010 20030
Chūōku, , Japan
As0010 20039
Iruma-gun, , Japan
As0010 20036
Kawachi-Nagano, , Japan
As0010 20045
Kita-gun, , Japan
As0010 20065
Kitakyushu, , Japan
As0010 20038
Nankoku-shi, , Japan
As0010 20037
Osaka, , Japan
As0010 20084
Saga, , Japan
As0010 20048
Saitama, , Japan
As0010 20031
Sapporo, , Japan
As0010 20035
Tokyo, , Japan
As0010 40038
Elblag, , Poland
As0010 40042
Krakow, , Poland
As0010 40037
Lublin, , Poland
As0010 40044
Poznan, , Poland
As0010 40040
Torun, , Poland
As0010 40041
Warsaw, , Poland
As0010 40039
Wroclaw, , Poland
As0010 40043
Wroclaw, , Poland
As0010 40045
A Coruña, , Spain
As0010 40046
Córdoba, , Spain
As0010 40047
Madrid, , Spain
As0010 40048
Santiago de Compostela, , Spain
As0010 40049
Seville, , Spain
As0010 40052
Ankara, , Turkey (Türkiye)
As0010 40053
Ankara, , Turkey (Türkiye)
As0010 40050
Istanbul, , Turkey (Türkiye)
As0010 40051
Izmir, , Turkey (Türkiye)
As0010 40057
Edinburgh, , United Kingdom
As0010 40056
Leeds, , United Kingdom
As0010 40054
London, , United Kingdom
As0010 40055
Norwich, , United Kingdom
Countries
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References
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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.
Navarro-Compan V, Rudwaleit M, Dubreuil M, Magrey M, Marzo-Ortega H, Mease PJ, Walsh JA, Dougados M, de la Loge C, Fleurinck C, Massow U, Vaux T, Taieb V, Deodhar A. Improved Pain, Morning Stiffness, and Fatigue With Bimekizumab in Axial Spondyloarthritis: Results From the Phase III BE MOBILE Studies. J Rheumatol. 2025 Jan 1;52(1):23-32. doi: 10.3899/jrheum.2024-0223.
Baraliakos X, Deodhar A, van der Heijde D, Magrey M, Maksymowych WP, Tomita T, Xu H, Massow U, Fleurinck C, Ellis AM, Vaux T, Shepherd-Smith J, Marten A, Gensler LS. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024 Jan 11;83(2):199-213. doi: 10.1136/ard-2023-224803.
van der Heijde D, Deodhar A, Baraliakos X, Brown MA, Dobashi H, Dougados M, Elewaut D, Ellis AM, Fleurinck C, Gaffney K, Gensler LS, Haroon N, Magrey M, Maksymowych WP, Marten A, Massow U, Oortgiesen M, Poddubnyy D, Rudwaleit M, Shepherd-Smith J, Tomita T, Van den Bosch F, Vaux T, Xu H. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023 Apr;82(4):515-526. doi: 10.1136/ard-2022-223595. Epub 2023 Jan 17.
Navarro-Compan V, Ramiro S, Deodhar A, Mease PJ, Rudwaleit M, de la Loge C, Fleurinck C, Taieb V, Morup MF, Massow U, Kay J, Magrey M. Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2. RMD Open. 2024 Apr 10;10(2):e004040. doi: 10.1136/rmdopen-2023-004040.
Dubreuil M, Navarro-Compan V, Boonen A, Gaffney K, Gensler LS, de la Loge C, Vaux T, Fleurinck C, Massow U, Taieb V, Morup MF, Deodhar A, Rudwaleit M. Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies. RMD Open. 2024 Jun 4;10(2):e004202. doi: 10.1136/rmdopen-2024-004202.
Cella D, de la Loge C, Fofana F, Guo S, Ellis A, Fleurinck C, Massow U, Dougados M, Navarro-Compan V, Walsh JA. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation. J Patient Rep Outcomes. 2024 Aug 12;8(1):92. doi: 10.1186/s41687-024-00769-x.
Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.
Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003064-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AS0010
Identifier Type: -
Identifier Source: org_study_id