Status:
COMPLETED
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Lead Sponsor:
AbbVie
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or ...
Eligibility Criteria
Inclusion
- Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 \[elsubrutinib/upadacitinib\] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
- On stable background treatment for SLE throughout the study.
Exclusion
- Active, chronic, or recurrent viral, or bacterial infection.
- Active tuberculosis (TB)
- History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
- Participant require vaccination with live vaccine during study participation.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2024
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04451772
Start Date
July 27 2020
End Date
January 3 2024
Last Update
January 14 2025
Active Locations (87)
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1
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
Phoenix, Arizona, United States, 85032-9306
2
Wallace Rheumatic Studies Center, LLC /ID# 224374
Beverly Hills, California, United States, 90211
3
Valerius Medical Group & Research Center /ID# 223922
Los Alamitos, California, United States, 90720-5402
4
East Bay Rheumatology Medical /ID# 225493
San Leandro, California, United States, 94578