Concert Pharmaceuticals Completes Enrollment in THRIVE-AA2 Phase 3 Clinical Trial Evaluating CTP-543 for Alopecia Areata
The THRIVE-AA clinical program includes two international Phase 3 studies, THRIVE-AA1 and THRIVE-AA2. Enrollment in the THRIVE-AA1 trial was completed in
“With both of our Phase 3 trials now fully enrolled and progressing toward completion, our focus will be on efficiently moving to data read out and preparing our New Drug Application, which we plan to submit to the FDA in the first half of 2023,” said
About the THRIVE-AA2 Study
THRIVE-AA2 (NCT04797650) is a randomized, double-blind, placebo-controlled clinical trial in adult patients with moderate to severe alopecia areata at sites in the
- Patient characteristics: adults age 18-65 years with ≥ 50% hair loss are eligible for the study;
- Enrollment size: 517 patients;
- Dosing: 8 mg twice-daily or 12 mg twice-daily of CTP-543 or placebo for 24 weeks; and
- Primary endpoint: percent of patients achieving a SALT score ≤ 20 at Week 24.
Further information about the THRIVE-AA clinical trials is available on www.clinicaltrials.gov.
About CTP-543 and Alopecia Areata
CTP-543 is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. The
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 1.5 million Americans at any given time1. 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. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.
The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the FDA’s Patient-Focused Drug Development meeting held in
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the development of CTP-543, the timing of availability of clinical trial data and the timing of regulatory filings, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the
1 Benigno M.Clinical, Cosmetic and Investigational Dermatology 2020