FDAnews Drug Daily Bulletin

FDA Lifts Hold on Concert’s Alopecia Clinical Trial

July 19, 2017

The FDA lifted a clinical hold on Concert Pharmaceuticals’ Phase IIa clinical trial of its CTP-543 treatment for alopecia areata. The company will amend its trial protocol to evaluate two doses of CTP-543, each for a 24 week duration.

Concert said it plans to resume enrollment later this month, and expects to complete the trial in the second half of 2018. The company’s CEO, Roger Tung, said the trial would take a more step-wise approach.

The trial is a double-blind, randomized, placebo-controlled trial that plans to enroll approximately 90 patients. The primary outcome will measure severity of alopecia after 24 weeks of dosing.

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