At a glance
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Rheumatoid Arthritis: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs
In Brief
A Phase 2 clinical trial evaluating Elsubrutinib, Upadacitinib, and 2 other interventions for Rheumatoid Arthritis (RA). Completed, enrolled 242 participants across 115 sites in 9 countries.
Detailed Summary
This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
Study Details
Timeline
Interventions
Elsubrutinib capsule will be administered orally.
Upadacitinib tablet will be administered orally.
Placebo capsule for elsubrutinib will be administered orally.
Placebo tablet for upadacitinib will be administered orally.