Ankylosing Spondylitis
Conditions
Sponsors
UCB Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients at least 18 years of age - Subject has ankylosing spondylitis 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 - 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 (TNF-alpha) 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
Exclusion criteria: - Total ankylosis of the spine - Treatment with more than 1 TNF-alpha inhibitor and/or more than 2 additional non-TNF-alpha 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 or human T-cell lymphotropic virus type-1 (HTLV-1). - 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 AS, including but not limited to rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, Crohn's disease, ulcerative colitis, or synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome - 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 |
|---|---|
| efficacy Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - ASAS40 response at Week 16 in TNF-alpha inhibitor-naive subjects - ASAS20 response at Week 16 - Change from Baseline in BASDAI at Week 16 - ASAS partial remission (ASAS-PR) at Week 16 - Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16 - ASAS5/6 response at Week 16 - Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 - Change from Baseline in nocturnal spinal pain (NRS) at Week 16 - Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16 - Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 16 - Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16 - Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 - Enthesitis-free state based on the MASES Index in the subgroup of subjects with enthesitis at Baseline at Week 16 - Incidence of treatment-emergent adverse events (TEAEs) - Incidence of serious adverse events (SAEs) - Adverse events (AEs) leading to withdrawal from IMP | — |
Countries
Asia except Japan, Japan, North America
Outcome results
None listed