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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 1,950 人开始时间: 2019年11月1日最近更新: 2020年5月4日

试验速览

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•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 1800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•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

发起方