China Medical System and its subsidiary Dermavon Holdings have reported positive data from a Phase III clinical trial of ruxolitinib cream (Opzelura) in participants with mild to moderate atopic dermatitis.
The placebo-controlled, randomised, multi-centre and double-blind study in China included 192 participants to assess the efficacy and safety of the cream in these individuals.
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Shanghai Dermatology Hospital was the leading institution for the study, with professor Shi Yuling serving as the principal investigator.
The trial achieved its primary endpoint, showing that a considerably greater percentage of participants treated with ruxolitinib reached an Investigator’s Global Assessment (IGA) score of zero or one, with at least a two-grade reduction from baseline at week eight, in contrast to those receiving a placebo.
In relation to the key secondary goal, the percentage of participants who experienced at least a 75% improvement from baseline in the Eczema Area and Severity Index score following treatment with the cream was found to be greater than that of the placebo group at week eight.
The intensity of treatment-emergent adverse events (TEAEs) observed during the treatment period was predominantly mild to moderate.
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By GlobalDataThere were no adverse events that resulted in the discontinuation of the drug while the cream was also found to be well-tolerated and safe.
The group is planning to submit a new drug application (NDA) in China for the product, which contains the selective Janus kinase 1 inhibitor(JAK1)/JAK2 inhibitor ruxolitinib, developed by Incyte.
The cream has received approval for use in the US from the Food and Drug Administration (FDA), as well as in Europe, to treat non-segmental vitiligo in adolescents and adults from 12 years of age.
