ASCLETIS-B (01672) completed the enrollment of patients in the phase III clinical trial of ASC40 (adapalene) once-daily oral tablets for the treatment of acne.

ASCLETIS-B (01672) announced that 480 patients have been enrolled in the Phase III clinical trial of ASC40 (dinolimabtes) once daily oral tablets for the treatment of moderate to severe acne. The first patient was enrolled on January 24, 2024. This Phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China, aimed at evaluating the safety and efficacy of ASC40 once daily oral tablets for the treatment of moderate to severe acne. The 480 patients with moderate to severe acne were randomized in a 1:1 ratio to receive either 50 mg of ASC40 once daily oral tablets or a matching placebo for 12 weeks. Top-line results are expected to be announced in the second quarter of 2025. The primary efficacy endpoints of the trial are the proportion of patients achieving treatment success at week 12, percentage change from baseline in total lesion count, and percentage change from baseline in inflammatory lesion count. Treatment success is defined as a decrease of at least 2 points from baseline in the Investigator's Global Assessment (IGA) score, with an IGA grade of clear (0) or almost clear (1).