Incyte (INCY) announced that the first vitiligo patient has been treated in the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream as monotherapy for adolescents and adults with vitiligo.

About the TRuE-V Trial

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. Each study intends to enroll  300 patients, age 12 and up, who are diagnosed with non-segmental vitiligo with depigmentation.  

More details are available in Incyte’s press release about the trial design, the required percentage of affected skin areas with vitiligo for recruitment, the primary & secondary endpoints required and the frequency and duration of any severe adverse effects that could be associated with the use of ruxolitinib cream.

About the Ruxolitinib

Ruxolitinib is a selective JAK1/JAK2 inhibitor. Incyte designed the topical cream version of ruxolitinib for the treatment of various skin diseases. In addition to the TRuE-V trial aimed at treating vitiligo, ruxolitinib cream is also in a Phase 3 clinical trial for patients with mild to moderate atopic dermatitis (TRuE-AD).

Initial results from the atopic dermatitis trial are expected in the first half of 2020.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

Prohost Observations

While Incyte has expanded the indications of its product Jakafi (ruxolitinib) to be approved for the treatment of: polycythemia vera, myelofibrosis and acute graft-versus-host disease, it is continuing to expand ruxolitinib’s market by conducting trials with the product for essential thrombocythemia, vitiligo and atopic dermatitis.    

With regard to competition, there are newly approved products from others that hit the market for atopic dermatitis but nothing is yet approved for vitiligo, which has yet to find a specific effective treatment. Many dermatologists and millions of vitiligo patients around the world are looking forward to having Incyte’s vitiligo topical product on the market. If ruxolitinib passes the clinical test and gets approval, we believe that the dermatologists will be delighted by their ability to treat a currently untreatable disfiguring autoimmune disease. A successful outcome of the vitiligo cream will be the best news the suffering patients have been hoping for but have never obtained since the day their immune system decided to attack their melanocyte cells that bring color to their skin.

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