Concert Pharmaceuticals announced that it will include an additional cohort of patients in the Phase 2a trial evaluating CTP-543. The protocol amendment provides for additional patients to be enrolled in the trial in order to evaluate a 12 mg dose of CTP-543 or placebo twice daily for 24 weeks. In 3Q18, an independent Data Monitoring Committee conducted a planned interim safety data review after patients in the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice daily for at least 12 weeks. Based on this review, the DMC provided its recommendation to continue with the current 8 mg cohort to completion and also provided support for an additional cohort to evaluate the 12 mg dose twice daily. The company has initiated enrollment in the 12 mg cohort. The company also expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in 4Q18. The Phase 2a trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. With the protocol amendment, patients are randomized to receive one of three doses of CTP-543 or placebo twice daily. Enrollment in the 4 mg and 8 mg cohorts is complete and enrollment in the 12 mg cohort is ongoing. The primary outcome measure will utilize the severity of alopecia tool after 24 weeks of dosing.
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