jRCT2080225271已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
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
- HiSCR50
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
- Randomized, double-blind, placebo-controlled, multicenter
- 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
- •Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is <20 years of age, written informed consent will be obtained from both the study participant and the legal representative.
- •Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit
- •Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits
- •Study participant must have moderate to severe HS defined as a total of >_5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits
- •Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history
- •A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP) OR
- •b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)
排除标准
- •Draining tunnel count of >20 at the Baseline Visit
- •Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS)
- •Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD)
- •Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy
- •Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
- •Active infection or history of certain infection(s)
- •Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection
- •Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured
- •History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- •Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol
- •Concomitant and prior medication restrictions
- •Myocardial infarction or stroke within the 6 months prior to the Screening Visit
- •Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- •Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
结局指标
主要结局
HiSCR50
时间窗: Week 16
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
次要结局
未报告次要终点
研究者
研究点 (1)
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