Incyte's ruxolitinib cream hits goal in vitiligo phase 3 trials, teeing up regulatory submissions

Phase 3 trials of Incyte’s ruxolitinib cream in patients with vitiligo have met their primary endpoints. The success of the topical JAK inhibitor tees Incyte up to seek approval in the U.S. and Europe in the second half of the year.

Incyte has worked to expand use of ruxolitinib, the active ingredient in Jakafi, to skin conditions in recent years. The effort is now manifesting in late-phase clinical trial data, enabling Incyte to apply for FDA approval of the topical formulation in atopic dermatitis and step up its preparations to file for authorization in vitiligo.

The vitiligo data come from two phase 3 trials, TRuE-V1 and TRuE-V2, that each enrolled more than  300 adolescents and adults with vitiligo, a skin condition defined by the loss of pigment cells. Incyte said ruxolitinib beat placebo in terms of the proportion of patients whose facial vitiligo improved by 75% or more at Week 24.

Details of how many patients met the F-VASI75 vitiligo score criteria remain underwraps, but Incyte said the overall efficacy and safety profile is consistent with its phase 2 results. In the earlier trial, 21% of patients who used the phase 3 dose—ruxolitinib cream 1.5% twice daily—experienced a 75% improvement by Week 24. The F-VASI75 rate rose to 66% by Week 104, although that figure comes from a smaller cohort as 41% of people were lost to follow-up. F-VASI75 at Week 52 was 37%.   

With no new safety signals emerging in the phase 3 trials, Incyte will prepare to file for approval while continuing the long-term efficacy and safety portions of the studies. Filings for approval for use in adolescents and adults in the U.S. and EU are planned for the second half of 2021.

If ruxolitinib cream comes to market in vitiligo, it could form part of a push into skin diseases at Incyte. The cream is also up for FDA review in atopic dermatitis, and an oral JAK inhibitor is now in a phase 2 vitiligo trial, reflecting Incyte’s belief that more than one drug may be needed to treat the full spectrum of disease severity.