Phase III TRuE-V trial of Opzelura showed improvement in nonsegmental vitiligo.- Incyte
Incyte announced new 52-week results from its pivotal Phase III TRuE-V clinical trial program evaluating Opzelura (ruxolitinib cream), a topical JAK1/JAK2 inhibitor, in adolescent and adult patients (age of at least 12 years) with nonsegmental vitiligo.
The 52-week results build on the previously announced positive 24-week results and include data from the 24-week double-blind and 28-week treatment extension periods of the Phase III TRuE-V1 and TRuE-V2 studies.
Findings from the Week 52 analysis showed that patients applying 1.5% ruxolitinib cream twice daily (BID) had clinically meaningful facial and total body repigmentation as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring (F-VASI and T-VASI, respectively) endpoints at Week 52. Specifically, efficacy results of patients who applied ruxolitinib cream from Day 1 showed: At Week 52, approximately 50% of patients achieved at least 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to the F-VASI75 improvement from baseline reported for these patients at Week 24 (the primary endpoint of the study) which was approximately 30%. At Week 52, approximately 75% of patients achieved at least 50% improvement in F-VASI (F-VASI50), and nearly one-third (approximately 30%) achieved at least 90% improvement in F-VASI (F-VASI90) compared to the Week 24 response rates for F-VASI50 and F-VASI90 which were approximately 51% and 15%, respectively. Additionally, a greater proportion of patients at Week 52 achieved at least 50% improvement in total body Vitiligo Area Scoring Index (T-VASI50), and over one-third of patients achieved a Vitiligo Noticeability Scale (VNS) response.
Further improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream was also observed. Results at Week 52 in crossover patients (those who received 28 weeks of treatment with ruxolitinib cream after initial treatment with vehicle cream) were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1. The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data – there were no clinically significant application site reactions or serious treatment-related adverse events related to ruxolitinib cream. These data were presented as an oral presentation in a late-breaking abstract session (Session #S026 – Late-Breaking Research: Clinical Trials) at the 2022 American Academy of Dermatology (AAD) Annual Meeting, held from March 25-29 in Boston.
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