FDA lifts hold on Concert Pharma’s study testing hair loss drug
Concert Pharmaceuticals Inc has said the U.S. Food and Drug Administration (FDA) lifted a clinical hold on a trial testing its therapy for alopecia areata, a type of hair loss.
The FDA had imposed a hold on the mid-stage study in May and asked for more data before Concert could proceed with dosing patients. The regulator had not raised any concerns about the drug’s safety, the drug developer had said.
Concert said on Monday it would modify the design of the study evaluating its drug, CTP-543, as a treatment for patients with moderate-to-severe alopecia areata.
About 90 patients will be enrolled in the trial and will be randomized to receive either one of two doses of the twice-daily drug – 4 mg and 8 mg – or a placebo.
The company, which said it would resume enrollment later this month, expects to complete the study in the second half of 2018.
The primary outcome of the trial will be measured after 24 weeks of dosing. Concert also said it might explore higher doses of the treatment.
Alopecia areata is an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss on the scalp and body.
The disease affects about 4.6 million people in the United States, according to the North American Hair Research Society.