Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
- Registration Number
- NCT03920267
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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)
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 1 BMS-986165 - BMS-986165 Dose 2 BMS-986165 - BMS-986165 Dose 3 BMS-986165 -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 30 days after last treatment dose (approximately 178 weeks) Number of participants with Serious Adverse Events (SAEs) Up to 30 days after last treatment dose (approximately 178 weeks) Number of participants with AEs leading to discontinuation Up to 30 days after last treatment dose (approximately 178 weeks) Number of participants with abnormal change from baseline in laboratory measurements over time Up to 30 days after last treatment dose (approximately 178 weeks) Number of participants with abnormal change from baseline in vital signs over time Up to 30 days after last treatment dose (approximately 178 weeks)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (97)
Local Institution - 0077
🇺🇸Birmingham, Alabama, United States
Local Institution - 0030
🇺🇸El Cajon, California, United States
Local Institution - 0049
🇺🇸Torrance, California, United States
Local Institution - 0074
🇺🇸New Haven, Connecticut, United States
Local Institution - 0115
🇺🇸Aventura, Florida, United States
Local Institution - 0044
🇺🇸Brandon, Florida, United States
Local Institution - 0140
🇺🇸Gainesville, Florida, United States
Local Institution - 0133
🇺🇸Orlando, Florida, United States
Local Institution - 0032
🇺🇸Ormond Beach, Florida, United States
Local Institution - 0048
🇺🇸Tampa, Florida, United States
Scroll for more (87 remaining)Local Institution - 0077🇺🇸Birmingham, Alabama, United States