EUCTR2016-003425-42-IT进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis -
CB Biopharma SR0 个研究点目标入组 567 人开始时间: 2021年2月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 567
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Must be at least 18 years of age
- •- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
- •- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale
- •- Subject is a candidate for systemic PSO therapy and/or phototherapy
- •- Female subject of child bearing potential must be willing to use highly effective method of contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 520
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Subject has an active infection (except common cold), a recent serious infection, or a history of
- •opportunistic or recurrent chronic infections
- •- Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV)
- •- 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 any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
- •- Presence of active suicidal ideation or positive suicide behavior
- •- Presence of moderately severe major depression or severe major depression
- •- 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
研究者
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