Aclaris Therapeutics completes enrollment in Phase 2b study of ATI-450

Aclaris Therapeutics announced the completion of enrollment into ATI-450-RA-202, its Phase 2b trial of oral zunsemetinib in patients with moderate to severe rheumatoid arthritis. Aclaris expects to announce top-line efficacy, safety and other preliminary data from this trial in the fourth quarter of this year. ATI-450-RA-202 is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, dose-ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of two doses of zunsemetinib plus methotrexate versus placebo plus MTX in patients with moderate to severe RA who have had an inadequate response to MTX alone. The study has enrolled 251 patients across the three treatment arms at over 20 trial sites in the U.S., Poland, Bulgaria and Czech Republic. The primary efficacy endpoint is the proportion of patients achieving an ACR20 response following 12 weeks of treatment. Secondary efficacy endpoints include ACR50 response, ACR70 response, DAS28-CRP and other pertinent RA measures.