A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
BE AGILE
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
2 other identifiers
interventional
303
10 countries
74
Brief Summary
This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
74 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
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
November 16, 2020
CompletedJune 6, 2023
May 1, 2023
1 year
November 10, 2016
October 21, 2020
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Week 12
Secondary Outcomes (8)
Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
From Baseline to Week 12
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
Week 12
Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
From Baseline to Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
From Baseline to Week 12
- +3 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORSubjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Bimekizumab Dose 1
EXPERIMENTALSubjects 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 Dose 2
EXPERIMENTALSubjects 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 Dose 3
EXPERIMENTALSubjects will receive for 48 Weeks Bimekizumab Dose 3.
Bimekizumab Dose 4
EXPERIMENTALSubjects will receive for 48 Weeks Bimekizumab Dose 4.
Interventions
Bimekizumab in different dosages.
Eligibility Criteria
You may qualify if:
- Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for \>=3 months and age of onset \<45 years
- Subject has moderate to severe active disease as defined by each of the following:
- BASDAI score \>=4
- 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:
- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
- intolerance to administration of at least 1 NSAID
- 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:
- experienced an inadequate response to previous treatment given for at least 12 weeks
- been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
- +1 more criteria
You may not qualify if:
- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
- 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:
- \<= 3 excised or ablated basal cell carcinomas of the skin
- 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
- Actinic keratosis (-es)
- Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
As0008 019
Anniston, Alabama, 36207, United States
As0008 007
La Jolla, California, 92037, United States
As0008 009
Upland, California, 91786, United States
As0008 005
Aventura, Florida, 33180, United States
As0008 022
Ormond Beach, Florida, 32174-11, United States
As0008 030
Sarasota, Florida, 34239, United States
As0008 027
Boston, Massachusetts, 02111, United States
As0008 021
Freehold, New Jersey, 07728, United States
As0008 015
Cleveland, Ohio, 44109-19, United States
As0008 014
Portland, Oregon, 97239, United States
As0008 001
Duncansville, Pennsylvania, 16635, United States
As0008 020
Austin, Texas, 78731, United States
As0008 006
Dallas, Texas, 75231, United States
As0008 018
Houston, Texas, 77030, United States
As0008 002
Seattle, Washington, 98122, 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
Related Publications (4)
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.
PMID: 32253184RESULTRobinson 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.
PMID: 35833532RESULTMease 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: 40194794DERIVEDDeodhar 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.
PMID: 39890205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273(UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 15, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
August 1, 2018
Last Updated
June 6, 2023
Results First Posted
November 16, 2020
Record last verified: 2023-05