Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus (IM011-074)
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- jRCT2080224856
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 360
Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
'-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 considered unsuitable by the investigator for any other reason -Evidence of active tuberculosis (TB)
Study & Design
- Study Type
- Interventional
- Study Design
- Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
US/Argentina/ Brazil/Canada/Colombia/Hungary/South Korea/Mexico/Poland/Romania/Spain/Taiwan
Location not specified
US/Argentina/ Brazil/Canada/Colombia/Hungary/South Korea/Mexico/Poland/Romania/Spain/Taiwan