WILMINGTON, Del.--(BUSINESS WIRE)--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.
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.
The primary endpoint of both studies in the TRuE-V program is the proportion of patients achieving F-VASI75, defined as at least a 75 percent improvement from baseline in the F-VASI score at Week 24. Key secondary endpoints include: the percentage change from baseline in facial BSA at Week 24, the proportion of patients achieving F-VASI50 (at least 50 percent improvement from baseline in the F-VASI), F-VASI90 (at least 90 percent improvement from baseline in the F-VASI) and T-VASI50 (at least 50 percent improvement from baseline in the T-VASI) at Week 24, the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50 and T-VASI75 (at least 75 percent improvement from baseline in the T-VASI) at Week 52 and the proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Week 24. The studies will also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild to moderate atopic dermatitis (TRuE-AD) with initial results expected in the first half of 2020, and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
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Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s ongoing clinical development program for ruxolitinib cream in patients with vitiligo, the enrollment, design, timing and results of the TRuE-V clinical trial program, and whether ruxolitinib cream will become an approved treatment option for patients with vitiligo, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending June 30, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.
- Kruger C. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212.
- Rodrigues M. New Discoveries in the pathogenesis and classification of vitiligo. J Am Acad Dermatol. 2017; 77:1-13.