Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis

JRCT ID: jRCT2080224973

Registered date:02/12/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Moderate-to-Severe Plaque Psoriasis
• Date of first enrollment: 12/08/2019
• Target sample size: 60
• Countries of recruitment: US
• Study type: Interventional
• Intervention(s): BMS-986165 will be administered orally at a dose of 6 mg QD.

Outcome(s)

• Primary Outcome: Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 96 weeks ]

Secondary Outcome

-static Physician Global Assessment (sPGA)0/1 response [ Time Frame: 96 weeks ]
-Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: 96 weeks ]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
-Women must not be pregnant, lactating, or breastfeeding

Exclude criteria

-Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
-To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

Related Information

• Primary Sponsor: Bristol-Myers Squibb
• Secondary ID(s): NCT04036435,JapicCTI-195061