A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
NCT ID: NCT02963506
Last Updated: 2023-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
303 participants
INTERVENTIONAL
2016-10-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Placebo
Bimekizumab Dose 1
Subjects will receive for 12 Weeks Bimekizumab Dose 1 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Bimekizumab
Bimekizumab in different dosages.
Bimekizumab Dose 2
Subjects will receive for 12 Weeks Bimekizumab Dose 2 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Bimekizumab
Bimekizumab in different dosages.
Bimekizumab Dose 3
Subjects will receive for 48 Weeks Bimekizumab Dose 3.
Bimekizumab
Bimekizumab in different dosages.
Bimekizumab Dose 4
Subjects will receive for 48 Weeks Bimekizumab Dose 4.
Bimekizumab
Bimekizumab in different dosages.
Interventions
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Placebo
Bimekizumab
Bimekizumab in different dosages.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has moderate to severe active disease as defined by each of the following:
1. BASDAI score \>=4
2. Spinal pain \>=4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)
* Subjects must have at least 1 of the following:
1. inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
2. intolerance to administration of at least 1 NSAID
3. contraindication(s) to NSAID therapy
* Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
* Subjects taking corticosteroids must be on an average daily dose of \<=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
* Subjects taking methotrexate (MTX) (\<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
* Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
* Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
1. experienced an inadequate response to previous treatment given for at least 12 weeks
2. been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
3. lost access to TNF inhibitor for other reasons
Exclusion Criteria
* Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
* Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
* Subjects receiving any live vaccination within the 8 weeks prior to Baseline
* Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
* Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
1. \<= 3 excised or ablated basal cell carcinomas of the skin
2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
3. Actinic keratosis (-es)
4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273(UCB)
Locations
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As0008 019
Anniston, Alabama, United States
As0008 007
La Jolla, California, United States
As0008 009
Upland, California, United States
As0008 005
Aventura, Florida, United States
As0008 022
Ormond Beach, Florida, United States
As0008 030
Sarasota, Florida, United States
As0008 027
Boston, Massachusetts, United States
As0008 021
Freehold, New Jersey, United States
As0008 015
Cleveland, Ohio, United States
As0008 014
Portland, Oregon, United States
As0008 001
Duncansville, Pennsylvania, United States
As0008 020
Austin, Texas, United States
As0008 006
Dallas, Texas, United States
As0008 018
Houston, Texas, United States
As0008 002
Seattle, Washington, United States
As0008 156
Dobrich, , Bulgaria
As0008 151
Plovdiv, , Bulgaria
As0008 154
Plovdiv, , Bulgaria
As0008 155
Plovdiv, , Bulgaria
As0008 150
Rousse, , Bulgaria
As0008 101
Québec, , Canada
As0008 100
Victoria, , Canada
As0008 103
Winnipeg, , Canada
As0008 205
Brno, , Czechia
As0008 206
Hustopeče, , Czechia
As0008 207
Olomouc, , Czechia
As0008 208
Pardubice, , Czechia
As0008 201
Prague, , Czechia
As0008 202
Prague, , Czechia
As0008 209
Prague, , Czechia
As0008 210
Prague, , Czechia
As0008 211
Prague, , Czechia
As0008 203
Zlín, , Czechia
As0008 302
Cologne, , Germany
As0008 304
Hamburg, , Germany
As0008 308
Hanover, , Germany
As0008 303
Herne, , Germany
As0008 301
Ratingen, , Germany
As0008 400
Budapest, , Hungary
As0008 403
Budapest, , Hungary
As0008 402
Debrecen, , Hungary
As0008 401
Veszprém, , Hungary
As0008 466
Bydgoszcz, , Poland
As0008 453
Elblag, , Poland
As0008 456
Elblag, , Poland
As0008 455
Krakow, , Poland
As0008 461
Lublin, , Poland
As0008 467
Nowa Sól, , Poland
As0008 451
Poznan, , Poland
As0008 462
Poznan, , Poland
As0008 450
Torun, , Poland
As0008 454
Warsaw, , Poland
As0008 459
Warsaw, , Poland
As0008 457
Wroclaw, , Poland
As0008 460
Wroclaw, , Poland
As0008 465
Wroclaw, , Poland
As0008 601
Moscow, , Russia
As0008 604
Moscow, , Russia
As0008 605
Moscow, , Russia
As0008 607
Moscow, , Russia
As0008 600
Saint Petersburg, , Russia
As0008 606
Saint Petersburg, , Russia
As0008 608
Saint Petersburg, , Russia
As0008 609
Saint Petersburg, , Russia
As0008 610
Saint Petersburg, , Russia
As0008 801
A Coruña, , Spain
As0008 800
Córdoba, , Spain
As0008 803
Santiago de Compostela, , Spain
As0008 700
Kiev, , Ukraine
As0008 707
Kyiv, , Ukraine
As0008 705
Ternopil, , Ukraine
As0008 708
Uzhhorod, , Ukraine
As0008 706
Vinnytsia, , Ukraine
As0008 704
Zaporizhya, , Ukraine
Countries
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References
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van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, Farmer MK, Baeten D, Goldammer N, Coarse J, Oortgiesen M, Dougados M. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2020 May;79(5):595-604. doi: 10.1136/annrheumdis-2020-216980. Epub 2020 Apr 6.
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.
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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2016-001102-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AS0008
Identifier Type: -
Identifier Source: org_study_id
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