Topline data from this dose regimen trial is expected in the first half of 2020.
“We are extremely grateful to the patients who volunteer to participate in our clinical trials and support our mission to develop a new treatment for alopecia areata. These patients, along with the investigators and their teams who work together with us, are essential in the development of new treatment options alopecia areata,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals.
The open label trial (NCT03941548) is a randomized, multi-center study in the United States and Canada to evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543 in 66 adult patients with moderate-to-severe alopecia areata. Patients in the trial were randomized to receive either 12 mg twice-daily or 24 mg once-daily of CTP-543 over a 24-week treatment period. The primary outcome measure is the relative change in Severity of Alopecia Tool (SALT) score at Week 24 from baseline. All patients who complete 24 weeks of treatment are eligible to enroll into a long term open label extension study of CTP-543.
Previously, the Company announced it has fully enrolled the first open label dose regimen trial evaluating 8 mg twice-daily compared to 16 mg once-daily of CTP-543 in patients with alopecia areata, with topline data from this trial expected in the fourth quarter of 2019. Available data from the dose regimen trials along with Concert’s recently completed Phase 2 study of CTP-543 are intended to support an end of Phase 2 discussion with the U.S. Food and Drug Administration (FDA) in the first quarter of 2020.
Source: Company Press Release