This multicenter, randomized study, known as AUAT-201, will evaluate the safety, tolerability and efficacy of ATI-501 oral suspension for the treatment of AU or AT in adult subjects. Aclaris intends to enroll approximately 80 subjects with a clinical diagnosis of stable AU or AT. Enrolled subjects will receive either ATI-501 or placebo for 6 months.
The primary efficacy endpoint is the mean change from baseline in the Severity of Alopecia Tool (SALT) score at Week 24. Secondary and exploratory endpoints include the change from baseline in the Alopecia Density and Extent Score (ALODEX) score and various clinician and patient-reported outcomes.
“This trial is the first step in evaluating the potential clinical benefit of ATI-501 oral suspension in treating patients with the alopecia totalis and alopecia universalis forms of alopecia areata,” said Dr.
About Alopecia Areata
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. AA can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ clinical development of its JAK inhibitor drug candidate ATI-501 oral suspension. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended
Senior Vice President
Corporate Strategy/Investor Relations
Source: Aclaris Therapeutics, Inc.