A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

Who is this study for? Patients with active non-radiographic axial spondyloarthritis
What treatments are being studied? Bimekizumab
Status: Completed
Location: See all (75) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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 nonradiographic axial spondyloarthritis (nr-axSpA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patients at least 18 years of age

• Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:

‣ Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria

⁃ Inflammatory back pain for at least 3 months

⁃ Age at symptom onset of less than 45 years

⁃ 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

Locations
United States
Arizona
As0010 50131
Mesa
As0010 50052
Phoenix
As0010 50062
Sun City
California
As0010 50060
Upland
Florida
As0010 50059
Ormond Beach
As0010 50056
Sarasota
Maryland
As0010 50015
Hagerstown
Missouri
As0010 50016
St Louis
Oregon
As0010 50055
Portland
Pennsylvania
As0010 50020
Duncansville
Tennessee
As0010 50012
Memphis
Texas
As0010 50057
Dallas
As0010 50036
Mesquite
Washington
As0010 50061
Spokane
Other Locations
Belgium
As0010 40004
Brussels
As0010 40003
Genk
As0010 40001
Ghent
As0010 40002
Merksem
Bulgaria
As0010 40006
Plovdiv
As0010 40007
Plovdiv
As0010 40005
Sofia
As0010 40008
Sofia
China
As0010 20040
Beijing
As0010 20021
Chengdu
As0010 20019
Guangzhou
As0010 20034
Hefei
As0010 20024
Nanjing
As0010 20018
Shanghai
As0010 20020
Shanghai
As0010 20026
Shanghai
As0010 20025
Wenzhou
France
As0010 40018
Boulogne-billancourt
As0010 40022
Limoges
Germany
As0010 40025
Berlin
As0010 40029
Hamburg
As0010 40024
Hanover
As0010 40027
Herne
As0010 40078
Leipzig
As0010 40026
Ratingen
Hungary
As0010 40032
Debrecen
As0010 40031
Szeged
As0010 40033
Székesfehérvár
As0010 40080
Szombathely
Japan
As0010 20030
Chūōku
As0010 20039
Iruma-gun
As0010 20036
Kawachi-nagano
As0010 20045
Kita-gun
As0010 20065
Kitakyushu
As0010 20038
Nankoku-shi
As0010 20037
Osaka
As0010 20084
Saga
As0010 20048
Saitama
As0010 20031
Sapporo
As0010 20035
Tokyo
Poland
As0010 40038
Elblag
As0010 40042
Krakow
As0010 40037
Lublin
As0010 40044
Poznan
As0010 40040
Torun
As0010 40041
Warsaw
As0010 40039
Wroclaw
As0010 40043
Wroclaw
Spain
As0010 40045
A Coruña
As0010 40046
Córdoba
As0010 40047
Madrid
As0010 40048
Santiago De Compostela
As0010 40049
Seville
Turkey
As0010 40052
Ankara
As0010 40053
Ankara
As0010 40050
Istanbul
As0010 40051
Izmir
United Kingdom
As0010 40057
Edinburgh
As0010 40056
Leeds
As0010 40054
London
As0010 40055
Norwich
Time Frame
Start Date: 2019-04-25
Completion Date: 2023-04-17
Participants
Target number of participants: 274
Treatments
Experimental: Bimekizumab
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Placebo_comparator: Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov