Policy & Regulation
Concert Pharmaceuticals Completes Enrollment in Second Open Label Trial of CTP-543 to Evaluate Once-Daily vs. Twice-Daily Dosing in Patients with Alopecia Areata
19 September 2019 - - US-based biopharmaceutical company Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) has completed patient enrollment of an open label clinical trial to evaluate once-daily 24 mg compared to twice-daily 12 mg oral dosing of CTP-543 in patients with alopecia areata, the company said.

Topline data from this dose regimen trial is expected in the first half of 2020.

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 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 US Food and Drug Administration in the first quarter of 2020.

In September 2019, the company reported topline results from its CTP-543 dose-ranging Phase 2 trial in patients with moderate-to-severe alopecia areata.

At 24 weeks, patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p