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FDA lifts clinical hold on trial for alopecia areata
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Concert Pharmaceuticals has announced that the FDA has lifted the clinical hold on the company’s CTP-543 phase 2a clinical trial for adults with alopecia areata.
The clinical stage biopharmaceutical company will amend the protocol for the study to evaluate two doses of CTP-543 each for a 24-week duration, according to a news release from Concert Pharmaceuticals.
CTP-543 applies Concert’s deuterium chemistry technology to modify ruxolitinib, a drug that selectively inhibits Janus kinases 1 and 2 and is commercially available under the name Jakafi (Incyte Corporation) in the United States for treating certain blood disorders, according to the release.
Enrollment in the double-blind, randomized trial will resume later this month. The trial is expected to be completed in the second half of 2018, according to the release.
The study will measure safety and efficacy of CTP-543 in approximately 90 adults with moderate-to-severe alopecia areata, who will be randomized to receive 4 mg or 8 mg twice daily of CTP-543 or placebo. The severity of alopecia tool will be used to measure primary outcome after 24 weeks of dosing, according to the release.
The FDA informed Concert Pharmaceuticals in May 2017 that a review of certain nonclinical toxicology studies was required before proceeding with the dosing in the trial, according to the release. Concert reports it submitted the requested study reports and agreed to amend clinical protocol.
“We believe the FDA is taking a measured approach for the development of Janus kinases inhibitors, or JAK inhibitors, for autoimmune dermatologic disorders, including alopecia areata,” Roger Tung, PhD, president and CEO of Concert Pharmaceuticals, stated in the release. “According, we agreed to modify the design or our phase 2a trial to evaluate CTP-543 in the patient population in a more step-wise fashion. It is important to note that CTP-543 has been well-tolerated in clinical evaluation to date and demonstrates a nonclinical safety profile consistent with JAK inhibition.”
Reference: www.concertpharma.com