jRCT2080224781已完成3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
UCB Japan Co., Ltd1 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- ASAS40 response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Double-blind, Placebo-controlled Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
结局指标
主要结局
ASAS40 response
时间窗: Week 16
Assessment of SpondyloArthritis International Society 40% response criteria
次要结局
未报告次要终点
研究者
研究点 (1)
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