Monday, June 29, 2020

CTP-543 Phase 3 Design

Concert Pharmaceuticals is planning on running two phase 3 clinical trials for the indication of Alopecia Areata, to begin in the fourth quarter of 2020. Detail's of the phase 3 trial are below.
  • Patients with moderate to severe Alopecia Areata
  • Approximately 700 patients age 18-65 years with ≥ 50% hair loss
  • Primary endpoint will be percentage of patients with SALT score ≤ 20
  • 3:3:1 randomization to CTP-543 (8 mg BID or 12 mg BID) or placebo for 24 weeks
I like the simple design of this clinical trial, and believe based on the phase 2 CTP-543 results and comparison Clinical Trial Comparison, they can score high efficacy in the range of SALT score ≤ 20. Below is a three year chart of CNCE. Thank you for reading.