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

UCB Japan Co., Ltd.1 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年6月7日

试验速览

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•Male or female patients at least 18 years of age.
•Patient has nonradiographic axial spondyloarthritis with all of the following criteria:
•1.Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) criteria.
•2.Inflammatory back pain for at least 3 months.
•3.Age at symptom onset of less than 45 years.
•4.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.
•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.

•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
•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 AxSpA, 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 (including pumping), 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

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