Concert Pharmaceuticals Completes Enrollment in Phase 2a Trial of CTP-543 in Alopecia Areata
Concert Pharmaceuticals announced that it has completed patient enrollment of its Phase 2a trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata. The Company expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in the fourth quarter of 2018. Additionally, a Phase 2b clinical trial is expected to begin in 2019.
“The speed with which we enrolled the trial speaks to the significant unmet need for alopecia areata and interest in this program. We are grateful to the patients who volunteered to participate in our trial,” stated James Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals.
The Phase 2a trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. Approximately 90 patients were randomized to receive one of two doses of CTP-543 (4 mg or 8 mg twice daily) or placebo. The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. If appropriate, the protocol may be amended to explore 12 mg twice daily of CTP-543.