BioCentury
ARTICLE | Clinical News

FDA places hold on Phase IIa of Concert's alopecia areata candidate

June 15, 2017 5:11 PM UTC

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) received notice that FDA placed a clinical hold on a Phase IIa trial of CTP-543 to treat moderate to severe alopecia areata. Concert said it had already started the trial with FDA’s blessing, but that the agency now says a “review of certain recently completed non-clinical toxicology studies is required before proceeding.” The company said it will “promptly” submit the requested data, which FDA intends to review as support for the 1-year dosing duration as planned in the Phase IIa trial. No patients have been dosed yet.

The double-blind, U.S. trial plans to evaluate hair loss as measured by the Severity of Alopecia Tool (SALT) at week 24 in about 100 patients receiving 4, 8, 12 or 16 mg oral CTP-543 or placebo twice daily for 24 weeks. All patients will then receive CTP-543 for an additional 28 weeks. The trial will also evaluate safety...