Aclaris Therapeutics, Inc. has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD).
Bosakitug is an investigational humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that specifically binds to human TSLP, blocking its interaction with the receptor complex and disrupting signal transduction.
This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in approximately 90 patients with moderate-to-severe atopic dermatitis. The primary endpoint is percent change from baseline in Eczema Area and Severity Index (EASI) at week 24. Secondary endpoints at week 24 include EASI response (EASI-50, EASI-75, EASI-90), validated Investigator Global Assessment (IGA) response, body surface area (BSA) response, and Peak Pruritus Numerical Rating Scale (PP-NRS) score, relative to baseline. Safety and tolerability will also be assessed.
“We are excited to initiate this Phase 2 trial following the strong single arm Phase 2a results in patients with moderate-to-severe AD,” says Dr. Jesse Hall, Chief Medical Officer of Aclaris, in a news release. “In that trial, bosakitug demonstrated improvements in efficacy measures at week 26 including EASI-75 scores in 94% of participants and clear or nearly clear skin in 88% of participants as measured by IGA scores of 0/1. With demonstrated superior potency and residence time, and unique TSLP binding characteristics, we believe that bosakitug is competitively positioned as a potential best-in-class anti-TSLP therapeutic monoclonal antibody. We expect to provide top line results from this trial in the second half of 2026.”
