Concert Pharmaceuticals has amended the protocol of a Phase lla trial evaluating CTP-543 for the treatment of patients with alopecia areata to include an additional cohort of patients.
The amendment will enable the company to include new patients for investigating a 12mg dose of CTP-543 or placebo twice daily for 24 weeks.
It follows a planned interim safety data review conducted by an independent Data Monitoring Committee (DMC) in the third quarter of this year.
Prior to the review, patients in the trial were treated with an 8mg dose of CTP-543 or placebo twice daily for around 12 weeks.
Following the review, the DMC suggested Concert Pharmaceuticals to continue with the 8mg cohort until completion and add new cohort to evaluate the 12mg dose.
Concert Pharmaceuticals has already started enrolling patients for the 12mg cohort, with plans to release topline data from the 4mg and 8mg cohorts of the trial by the last quarter of this year.
Concert Pharmaceuticals chief development officer James Cassella said: “We believe that understanding a broader dose range in the Phase lla trial will be important to our selection of the CTP-543 doses for late-stage clinical development.”
The Phase lla trial is a double-blind, randomised, placebo-controlled, sequential dose study that is designed to investigate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata.
In line with the latest amendment, Concert Pharmaceuticals has randomised the patients to receive one of three doses of CTP-543 or placebo twice a day.
The company has concluded patient enrolment in the 4mg and 8mg cohorts, and is currently enrolling patients in the 12mg cohort.
The primary outcome measure of the trial is to use the severity of alopecia tool (SALT) after 24 weeks of dosing.