Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program Evaluating Ruxolitinib Cream in Patients with Vitiligo

Incyte (Nasdaq:INCY) today announced that the first patient has been treated in the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream as a monotherapy for adolescent and adult patients (age ≥12 years) with vitiligo.

“Vitiligo is a challenging and life-altering disease further complicated by the lack of effective treatment options available to physicians and their patients,” said Jim Lee, M.D., Ph.D., Group Vice President and Head of Inflammation and Autoimmunity Group, Incyte. “The initiation of the global Phase 3 TRuE-V clinical trial program is an important milestone as we seek to provide a treatment option that offers meaningful improvements for vitiligo patients.”

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. It affects approximately 0.5 percent to 2.0 percent of the population globally¹ and there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved drug therapies for the treatment of vitiligo. It can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 20².

About TRuE-V

The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.

The studies will each enroll approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5 percent of the body surface area (BSA) on the face, ≥0.5 facial vitiligo area severity index [F-VASI] score, at least 3 percent 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 percent. Participants will be randomized to two arms: 1.5 percent ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period. Patients who successfully complete baseline and Week 24 assessments, including those that received vehicle control during the double-blind phase, will be offered treatment extension with 1.5 percent ruxolitinib cream BID for an additional 28 weeks.