A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
NCT ID: NCT03355573
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2017-11-28
2022-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bimekizumab
Subjects will receive bimekizumab up to 4 years.
Bimekizumab
Bimekizumab at a prespecified dose.
Interventions
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Bimekizumab
Bimekizumab at a prespecified dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject completed AS0008 without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Exclusion Criteria
* Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
* Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009
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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As0009 30
Sarasota, Florida, United States
AS0009 1
Duncansville, Pennsylvania, United States
AS0009 6
Dallas, Texas, United States
As0009 156
Dobrich, , Bulgaria
As0009 151
Plovdiv, , Bulgaria
As0009 155
Plovdiv, , Bulgaria
As0009 150
Rousse, , Bulgaria
As0009 101
Québec, , Canada
As0009 205
Brno, , Czechia
As0009 207
Olomouc, , Czechia
As0009 208
Pardubice, , Czechia
As0009 201
Prague, , Czechia
As0009 202
Prague, , Czechia
As0009 211
Prague, , Czechia
As0009 210
Praha 11 Chodov, , Czechia
As0009 203
Zlín, , Czechia
As0009 304
Hamburg, , Germany
As0009 301
Ratingen, , Germany
As0009 400
Budapest, , Hungary
As0009 403
Budapest, , Hungary
As0009 401
Veszprém, , Hungary
As0009 466
Bydgoszcz, , Poland
As0009 453
Elblag, , Poland
As0009 456
Elblag, , Poland
As0009 455
Krakow, , Poland
As0009 461
Lublin, , Poland
As0009 467
Nowa Sól, , Poland
As0009 451
Poznan, , Poland
As0009 450
Torun, , Poland
As0009 454
Warsaw, , Poland
As0009 459
Warsaw, , Poland
As0009 457
Wroclaw, , Poland
As0009 460
Wroclaw, , Poland
As0009 465
Wroclaw, , Poland
As0009 601
Moscow, , Russia
As0009 604
Moscow, , Russia
As0009 607
Moscow, , Russia
As0009 600
Saint Petersburg, , Russia
As0009 606
Saint Petersburg, , Russia
As0009 608
Saint Petersburg, , Russia
As0009 610
Saint Petersburg, , Russia
As0009 801
A Coruña, , Spain
As0009 800
Córdoba, , Spain
As0009 803
Santiago de Compostela, , Spain
As0009 700
Kyiv, , Ukraine
As0009 707
Kyiv, , Ukraine
As0009 705
Ternopil, , Ukraine
As0009 708
Uzhhorod, , Ukraine
As0009 706
Vinnytsia, , Ukraine
As0009 704
Zaporizhzhia, , Ukraine
Countries
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References
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Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, Kivitz AJ, Poddubnyy D, Oortgiesen M, Vaux T, Fleurinck C, Shepherd-Smith J, de la Loge C, de Peyrecave N, van der Heijde D. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958. doi: 10.1002/art.42282. Epub 2022 Nov 7.
Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.
Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
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.
Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001002-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AS0009
Identifier Type: -
Identifier Source: org_study_id
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