Nonradiographic axial spondyloarthritis MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patients at least 18 years of age -Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria: a) Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria b) Inflammatory back pain for at least 3 months c) Age at symptom onset of less than 45 years. d) 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 must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) to NSAID therapy -Patients who have taken a tumor necrosis factor alpha (TNFa) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 237 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: -Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa biological response modifiers, or any interleukin (IL)-17 biological response modifier -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 axial spondyloarthritis (axSpA), including but not limited to psoriatic athritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA);Secondary Objective: - Assess the efficacy of bimekizumab compared to placebo - Assess the safety and tolerability of bimekizumab - Assess the impact of bimekizumab on patient-reported quality of life - Assess the impact of bimekizumab on spinal mobility - Assess the impact of bimekizumab on enthesitis and on peripheral arthritis ;Primary end point(s): Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16 ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFa inhibitor-naïve subjects at Week 16 2. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16 3. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16 4. Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16 5. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16 6. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16 7. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 8. Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16 9. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16 10. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 16 11. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16 12. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 13. Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 14. Incidence of treatment-emergent adverse events (TEAEs) during the study 15. Incidence of treatment-emergent serious adverse events (SAEs) during the study 16. Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study ;Timepoint(s) of evaluation of this end point: 1.; 3.-6. Week 16 2.; 7.-13. Baseline, Week 16 14.-16. From Baseline (Day 1) until Safety Follow-Up (up to Week 72) | — |
Countries
Belgium, Bulgaria, China, Czechia, Czech Republic, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed