Incyte has announced positive topline results from its pivotal Phase 3 TRuE-V trial program that evaluated topical ruxolitinib, 1.5% cream in non-segmental vitiligo.
The trials met their primary goals, showing that significantly more patients treated with topical ruxolitinib twice daily achieved a 75% improvement in facial vitiligo, compared to patients treated with control only. The progress was measured by F-VASI75 score from the baseline. The study also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream—and so far, no new safety signals were reported.
The company has worked to develop topically delivered ruxolitinib to different skin conditions, like atopic dermatitis and vitiligo, in recent years. Part of the effort has culminated in two Phase 3 trials, TRuE-V1 and TRuE-V2, that each enrolled more than 300 patients aged 12 and above. Details of how many patients met the F-VASI75 score criteria and secondary endpoint remain undisclosed for now. Hopefully, it will be shared at a scientific congress and a medical journal later this year.
However, Incyte shared the overall efficacy and safety profile is consistent with its Phase 2 results. In the earlier trial approximately 30% 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 51% by one year and 66% by two years, although the figure comes from a smaller cohort as some people were lost to follow-up during the course of the study.
An oral JAK1 inhibitor is also in a Phase 2 vitiligo trial, with promising outlook, reflecting Incyte’s belief that more than one drug may be needed to treat the full spectrum of disease severity.
Based on the outcomes, Incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age 12+ years) to the U.S. FDA and the European Medicines Agency (EMA) in the second half of 2021.
More on ruxolitinib in: JAKs Of All Trades
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