Policy & Regulation
Incyte Touts Positive 52-Week Results from a Randomised Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo
18 October 2019 - - US-based biopharmaceutical company Incyte (NASDAQ: INCY) has received positive 52-week results from its randomised, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo, the company said.

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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