Aclaris Completes Enrollment of 109 Patients in Phase 2 Atopic Dermatitis Trial and Sets Q4 2026 Readout
Aclaris Therapeutics has completed enrollment of 109 moderate-to-severe atopic dermatitis patients in its randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045). The trial’s primary endpoint is percent change in Eczema Area and Severity Index at week 24 and topline data are projected in the fourth quarter of 2026.
1. Enrollment Completion
Aclaris has enrolled 109 patients with moderate-to-severe atopic dermatitis in its randomized, double-blind, placebo-controlled Phase 2 study of bosakitug (ATI-045). This milestone follows strong investigator interest and completes the recruitment phase ahead of data analysis.
2. Trial Endpoints and Timeline
The primary efficacy measure is percent change from baseline in Eczema Area and Severity Index (EASI) at week 24. Secondary endpoints include EASI-50, EASI-75, EASI-90 responses, Investigator Global Assessment, body surface area response and Peak Pruritus Numerical Rating Scale, with topline results scheduled for Q4 2026.
3. Bosakitug Mechanism and Potential
Bosakitug is a humanized anti-TSLP monoclonal antibody designed to block thymic stromal lymphopoietin and downstream proinflammatory cytokine release. Its high affinity, low dissociation rate and 23-day half-life support potential best-in-class potency and extended dosing intervals.