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)
Part of paid clinical trials in Mesa, Arizona.
- Sponsor
- AbbVie
- Study ID
- NCT03978520
- Phase
- PHASE2
- Status
- Completed
Conditions
- Systemic Lupus Erythematosus (SLE)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Elsubrutinib — DRUGCapsule; Oral
- Placebo for elsubrutinib — DRUGCapsule; Oral
- Upadacitinib — DRUGFilm-coated tablet; Oral
- Placebo for upadacitinib — DRUGFilm-coated tablet; Oral
Study Details
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations 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.
Key Dates
- Start date
- Jul 25, 2019
- Status verified
- Jun 2023
- Primary completion
- Jan 19, 2022
- Completion
- Jul 14, 2022
Study Design
- Enrollment
- 341 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Elsubrutinib placebo/upadacitinib placeboPlacebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
- Experimental: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
- Experimental: Elsubrutinib placebo/upadacitinib 30 mgPlacebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
- Experimental: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
- Experimental: Elsubrutinib 60 mg/upadacitinib placebo60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
Primary Outcome Measure
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24 [ Time Frame: Baseline, Week 24 ]
Locations (47)
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By research site
Arizona Arthritis & Rheumatology Research, PLLC· Mesa, AZAZ Arthritis and Rheumotology Research, PLLC· Phoenix, AZArthritis and Rheumatism Associates· Jonesboro, ARWallace Rheumatic Studies Center, LLC· Beverly Hills, CAArthritis & Osteo Medical Ctr· La Palma, CAValerius Medical Group & Research Center· Los Alamitos, CA
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