Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
Incyte published a press release on the success of their Phase 3 Clinical Trial for ruxolitinib. A summary is below.
- Ruxolitinib cream is a nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy that was tested on adolescent and adult patients (age ≥12 years) with vitiligo.
- The clinical trial showed that 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 control cream at Week 24.
- The studies tracked the frequency, duration, and severity of adverse events associated with the use of ruxolitinib cream. 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.
- 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. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the second half of 2021.
- The studies each enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial vitiligo area severity index [F-VASI] score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) of up to 10%.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development, and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
Incyte is a past and present sponsor of GVF. This is an unpaid post.