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2024-09-17 19:04
The Phase 2a trial is an open-label study to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 administered over 12 weeks in patients with moderate to severe atopic dermatitis. Aclaris' planned enrollment for this trial is approximately 15 subjects, and the trial will be conducted in the United States. The primary endpoints are safety-related parameters. Secondary endpoints include Eczema Area and Severity Index (EASI) response measures, including EASI-50, EASI-75, and EASI-90, Validated Investigator Global Assessment (vIGA) response, body surface area (BSA) response and other pertinent efficacy related measures. Aclaris expects topline data from this trial in the first half of 2025