Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

Summary

This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.

Timeline

Start

2019-07-04

Primary completion

2021-04-27

Completion

2021-04-27

Outcome

Met primary endpoint

release “In June, Abivax announced that ABX464 met the primary endpoint in a phase 2a study in rheumatoid arthritis (RA) patients” abivax.com ↗

Publications

• Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 Jul 12;81(8):1076-1084. doi: 10.1136/annrheumdis-2022-222228.

Drugs

Indications