Clinical trial NCT03928743: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
AS
Bimekizumab
Axial spondyloarthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-04-26
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 18 years of age
* Subject has ankylosing spondylitis (AS) as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years
* Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale
* 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:

* Total ankylosis of the spine
* Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded
* 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 AxSpA, eg, rheumatoid 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

Primary outcomes:
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response in TNFα Inhibitor-naïve Participants at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society 20% Response Criteria (ASAS20) Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Nocturnal Spinal Pain Score Numeric Rating Scale (NRS) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the Subgroup of Participants With Enthesitis at Baseline at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Enthesitis-free State at Week 16 Based on the Maastricht Ankylosing Spondylitis Enthesitis Index in the Subgroup of Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
timeFrame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
timeFrame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: As0011 50131
state: Arizona
city: Phoenix
country: United States
facility: As0011 50052
state: Arizona
city: Phoenix
country: United States
facility: As0011 50058
state: Arizona
city: Sun City
country: United States
facility: As0011 50062
state: Arizona
city: Upland
country: United States
facility: As0011 50060
state: California
city: Sarasota
country: United States
facility: As0011 50056
state: Florida
city: Hagerstown
country: United States
facility: As0011 50015
state: Maryland
city: Saint Louis
country: United States
facility: As0011 50016
state: Missouri
city: Oklahoma City
country: United States
facility: As0011 50054
state: Oklahoma
city: Duncansville
country: United States
facility: As0011 50020
state: Pennsylvania
city: Jackson
country: United States
facility: As0011 50001
state: Tennessee
city: Memphis
country: United States
facility: As0011 50012
state: Tennessee
city: Dallas
country: United States
facility: As0011 50057
state: Texas
city: Mesquite
country: United States
facility: As0011 50036
state: Texas
city: Bruxelles
country: Belgium
facility: As0011 40004
city: Genk
country: Belgium
facility: As0011 40003
city: Gent
country: Belgium
facility: As0011 40001
city: Plovdiv
country: Bulgaria
facility: As0011 40006
city: Plovdiv
country: Bulgaria
facility: As0011 40007
city: Sofia
country: Bulgaria
facility: As0011 40005
city: Sofia
country: Bulgaria
facility: As0011 40008
city: Beijing
country: China
facility: As0011 20040
city: Chengdu
country: China
facility: As0011 20021
city: Guangzhou SHI
country: China
facility: As0011 20019
city: Hefei
country: China
facility: As0011 20034
city: Nanjing
country: China
facility: As0011 20024
city: Shanghai
country: China
facility: As0011 20018
city: Shanghai
country: China
facility: As0011 20020
city: Shanghai
country: China
facility: As0011 20026
city: Wenzhou
country: China
facility: As0011 20025
city: Brno
country: Czechia
facility: As0011 40011
city: Pardubice
country: Czechia
facility: As0011 40009
city: Praha 11
country: Czechia
facility: As0011 40013
city: Praha 2
country: Czechia
facility: As0011 40016
city: Praha 4
country: Czechia
facility: As0011 40014
city: Praha
country: Czechia
facility: As0011 40015
city: Uherske Hradiste
country: Czechia
facility: As0011 40010
city: Zlin
country: Czechia
facility: As0011 40012
city: Boulogne Billancourt
country: France
facility: As0011 40018
city: Limoges
country: France
facility: As0011 40022
city: Berlin
country: Germany
facility: As0011 40025
city: Berlin
country: Germany
facility: As0011 40028
city: Hamburg
country: Germany
facility: As0011 40029
city: Hanover
country: Germany
facility: As0011 40024
city: Herne
country: Germany
facility: As0011 40027
city: Leipzig
country: Germany
facility: As0011 40078
city: Ratingen
country: Germany
facility: As0011 40026
city: Debrecen
country: Hungary
facility: As0011 40032
city: Szeged
country: Hungary
facility: As0011 40031
city: Szombathely
country: Hungary
facility: As0011 40080
city: Székesfehérvár
country: Hungary
facility: As0011 40033
city: Chuo-ku
country: Japan
facility: As0011 20030
city: Himeji-shi
country: Japan
facility: As0011 20047
city: Kita-gun
country: Japan
facility: As0011 20045
city: Kitakyushu
country: Japan
facility: As0011 20065
city: Osaka
country: Japan
facility: As0011 20037
city: Saga
country: Japan
facility: As0011 20084
city: Saitama
country: Japan
facility: As0011 20048
city: Sapporo
country: Japan
facility: As0011 20031
city: Sasebo
country: Japan
facility: As0011 20042
city: Suita
country: Japan
facility: As0011 20032
city: Tokyo
country: Japan
facility: As0011 20035
city: Amsterdam
country: Netherlands
facility: As0011 40034
city: Elblag
country: Poland
facility: As0011 40038
city: Krakow
country: Poland
facility: As0011 40042
city: Lublin
country: Poland
facility: As0011 40037
city: Poznan
country: Poland
facility: As0011 40044
city: Torun
country: Poland
facility: As0011 40040
city: Warszawa
country: Poland
facility: As0011 40041
city: Wroclaw
country: Poland
facility: As0011 40039
city: Wroclaw
country: Poland
facility: As0011 40043
city: A Coruna
country: Spain
facility: As0011 40045
city: Cordoba
country: Spain
facility: As0011 40046
city: Madrid
country: Spain
facility: As0011 40047
city: Santiago de Compostela
country: Spain
facility: As0011 40048
city: Sevilla
country: Spain
facility: As0011 40049
city: Ankara
country: Turkey
facility: As0011 40052
city: Ankara
country: Turkey
facility: As0011 40053
city: Istanbul
country: Turkey
facility: As0011 40050
city: Edinburgh
country: United Kingdom
facility: As0011 40057
city: Leeds
country: United Kingdom
facility: As0011 40056
city: London
country: United Kingdom
facility: As0011 40054
city: Norwich
country: United Kingdom
facility: As0011 40055
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.