Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus
Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus
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).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Actual Study Start Date: March 26, 2019
Estimated Primary Completion Date: January 8, 2023
Estimated Study Completion Date: January 8, 2023
Arm:
- Experimental: BMS-986165 Dose 1
- Experimental: BMS-986165 Dose 2
- Experimental: BMS-986165 Dose 3
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 360 |
| Actual Study start date | 26 March 2019 |
| Estimated Study Completion Date | 08 January 2023 |