A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

UCB Japan Co., Ltd1 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年6月7日

适应症

试验速览

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•Subject is male or female at least 18 years of age
•Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
•Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
•Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
•Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
•Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(alpha)) inhibitors for either PsA or PSO
•Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

•Female subjects who are breastfeeding(including pumping), pregnant, or plan to become pregnant during the study
•Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
•Subject has an active infection or a history of recent serious infections
•Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
•Subject has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to RA, sarcoidosis, systemic lupus erythematosus, reactive arthritis, Crohn's disease, or ulcerative colitis.

efficacy American College of Rheumatology (ACR) 50 response at Week 16

发起方

UCB Japan Co., Ltd

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