China Medical System Holdings Announces Positive Phase 3 Trial Results for Ruxolitinib Cream in Chinese Atopic Dermatitis Patients
Reuters
Sep 26
China Medical System Holdings Announces Positive Phase 3 Trial Results for Ruxolitinib Cream in Chinese Atopic Dermatitis Patients
China Medical System Holdings Ltd. has announced positive results from a Phase 3 clinical trial evaluating ruxolitinib cream in Chinese patients with mild to moderate atopic dermatitis. The randomized, double-blind, placebo-controlled, multi-centre study enrolled 192 patients and was led by Shanghai Dermatology Hospital. The trial met its primary endpoint, with 63.0% of patients treated with ruxolitinib cream achieving an Investigator's Global Assessment $(IGA)$ of 0 or 1 with at least two grades of reduction from baseline at week 8, compared to 9.2% in the placebo group (P<0.001). The key secondary endpoint was also met, with 78.0% of patients in the ruxolitinib group achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75), compared to 15.4% for placebo (P<0.001). The safety profile showed that treatment-emergent adverse events were mostly mild or moderate, with no discontinuations due to adverse events. Results of the trial have already been announced by the company.
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