EUCTR2016-001892-57-HU进行中（未招募）1 期
A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis.
CB Biopharma SPR0 个研究点目标入组 240 人开始时间: 2016年9月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •- Subject has provided informed consent.
- •- Subject completes all dosing requirements in feeder study and completes PS0010 without meeting any withdrawal criteria.
- •- Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Subject has previously participated in this study.
- •- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose.
- •- Subject has any medical of psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject´s ability to participate in this study.
- •- Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010.
研究者
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