- Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies
- Data will support planned U.S. and EU regulatory submissions for ruxolitinib cream in vitiligo in the second half of 2021
Incyte 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.
“These positive results – the first Phase 3 data to demonstrate significant improvements in facial and total body repigmentation – confirm the potential of ruxolitinib cream to be a meaningful treatment option for individuals living with and seeking treatment for their vitiligo,” said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “We look forward to working with regulators to bring this much needed treatment option to patients. If approved, ruxolitinib cream would be the first and only medical treatment for repigmentation in vitiligo.”
Based on these findings, 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 FDA is currently reviewing a New Drug Application (NDA) for ruxolitinib cream for the treatment of adolescents and adults (age ≥12 years) with atopic dermatitis, a type of eczema.
“Vitiligo is a chronic immune-mediated skin condition that can significantly impact quality of life for those living with, and suffering from, this disease,” said David Rosmarin, M.D., Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. “As a clinician, I am extremely encouraged by the initial findings from the TRuE-V program and the potential to have ruxolitinib cream as a future topical treatment option for vitiligo patients, who currently have limited therapies available that effectively and safely address repigmentation.”