A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Actual Study Start Date: July 25, 2019
Estimated Primary Completion Date: December 17, 2021
Estimated Study Completion Date: July 2, 2022
Arm:
- Experimental: Group 1: Upadacitinib and Elsubrutinib
- Experimental: Group 2: Upadacitinib and Elsubrutinib
- Experimental: Group 3: Elsubrutinib and Placebo for Updadacitinib
- Experimental: Group 4: Upadacitinib and Placebo for Elsubrutinib
- Experimental: Group 5: Placebo for Elsubrutinib and Placebo for Upadacitinib
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 310 |
| Actual Study start date | 25 July 2019 |
| Estimated Study Completion Date | 02 July 2022 |