Benzinga | May 17, 2021 07:32AM EDT

Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo; Co. Reports 'Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies'

Incyte (NASDAQ:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ?12 years) with vitiligo.

Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint (p<0.0001 for both studies), demonstrating that significantly more patients treated with ruxolitinib cream 1.5% twice daily (BID) achieved a ?75% improvement from baseline in the facial vitiligo area scoring index (F-VASI75) compared to patients treated with a vehicle control at Week 24.

The studies also met key secondary endpoints including patient reported outcomes. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed. The long-term efficacy and safety portions of both studies will continue as planned. Additionally, data from both studies will be submitted for publication and presentation at an upcoming scientific meeting in the second half of 2021.