A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

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.

Timeline

Start

2018-10-08

Primary completion

2020-03-26

Completion

2020-03-26

Publications

• Fleischmann R, Friedman A, Drescher E, Singhal A, Cortes-Maisonet G, Doan T, Lu W, Wang Z, Nader A, Housley W, Cohen S, Taylor PC, Blanco R. Safety and efficacy of elsubrutinib or upadacitinib alone or in combination (ABBV-599) in patients with rheumatoid arthritis and inadequate response or intolerance to biological therapies: a multicentre, double-blind, randomised, controlled, phase 2 trial. Lancet Rheumatol. 2022 Jun;4(6):e395-e406. doi: 10.1016/S2665-9913(22)00092-3. Epub 2022 Apr 27.

Drugs

Indications