Cara Therapeutics says no modifications in trial size for Phase 2 KORSUVA trial
Cara Therapeutics announced the completion of an interim statistical assessment of its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V chronic kidney disease. In addition, the Company announced that the trial is now fully enrolled at 240 patients. Based on the recommendation of the Independent Data Monitoring Committee, the trial does not require any modifications to the original enrollment target of 240 patients. The IDMC's recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the 240 patients had completed the designated 12-week treatment period. The Phase 2, multicenter, randomized, double-blind, placebo-controlled, 12-week trial is designed to evaluate the safety and efficacy of three dose levels of Oral KORSUVA versus placebo in approximately 240 stage III-V CKD patients with moderate-to-severe pruritus. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at Week 12 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores at the end of Week 12, as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline greater than or equal to3 points with respect to the weekly mean of the daily 24-hour Worst Itch NRS score at Week 12.