2022-502361-15-00招募中3 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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 664
- 试验地点
- 60
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
- •Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF)
- •Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period(must have a negative urine test 24 hours prior to the start of study drug)
排除标准
- •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
- •Prior permanent discontinuation of study treatment in the parent study
- •Findings Related to Possible TB Infection
- •Evidence of active TB
研究组 & 干预措施
deucravacitinib
Experimental
Participants receiving deucravacitinib
干预措施: deucravacitinib (Drug)
结局指标
主要结局
Adverse events and serious adverse events
Adverse events and serious adverse events
次要结局
- sPGA 0/1 response
- PASI 75 response
研究者
GCT-SU
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (60)
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