Cara Therapeutics announces topline results from its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients
Study did not meet Primary Endpoint of worst-itch NRS change from baseline at week 12 or Secondary Endpoint of 4-point responder analysis in the ITT patient population.Study achieved Primary Endpoint of worst-itch NRS change and Secondary Endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients (64% of ITT patient population).Statistically significant improvement in 4-point responder analysis in mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group (p=0.03).KORSUVA was well tolerated at all dose levels.
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