As previously announced, the study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50% improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with a vehicle control (non-medicated cream).
Updated results at week 52 show substantial improvements in total body repigmentation with ruxolitinib cream, measured by the proportion of patients achieving a ≥50% improvement from baseline in the total vitiligo area severity index (T-VASI50), a key secondary endpoint.
In addition, after 52 weeks of treatment with ruxolitinib cream 1.5% administered twice daily, 58% of patients achieved F-VASI50 and 51 % of patients achieved a ≥75% improvement (F-VASI75).
F-VASI75 after 24 weeks is the primary outcome measure of both the TRuE-V1 and TRuE-V2 randomised Phase 3 trials that are already underway.
Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.
Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild to moderate atopic dermatitis (TRuE-AD) with initial results expected in the first half of 2020, and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialisation of ruxolitinib cream.
Incyte Corp. is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialisation of proprietary therapeutics.
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