EUCTR2019-000612-29-PL进行中(未招募)1 期
An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 1,560
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
- •1) Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
- •2) Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF).
- •3) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period (must have a negative urine pregnancy test
- •24 hours prior to the start of study drug.
- •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 1404
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •1) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
- •2) Prior permanent discontinuation of study treatment in the parent study
- •3) Findings Related to Possible TB Infection
- •4) Evidence of active TB
研究者
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