Positive topline data were announced from the phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream in patients 12 years of age and older with vitiligo.
The TRuE-V program includes 2 randomized, double-blind, vehicle-controlled phase 3 studies: TRuE-V1 (ClinicalTrials.gov: NCT04052425) and TRuE-V2 (ClinicalTrials.gov: NCT04057573). Each study evaluated the efficacy and safety of a topical cream formulation of ruxolitinib, a selective JAK1/JAK2 inhibitor, in approximately 300 patients 12 years of age and older who have been diagnosed with nonsegmental vitiligo and have depigmented areas. Patients were randomly assigned 1:1 to receive ruxolitinib 1.5% cream twice daily or vehicle for 24 weeks.
The primary endpoint for both studies was the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the Face Vitiligo Area Scoring Index (F-VASI) score at week 24. Key secondary endpoints included the percentage change from baseline in facial body surface area (F-BSA) at week 24, the proportion of patients achieving F-VASI50, F-VASI90, and T-VASI50 (defined as at least a 50% improvement from baseline in the total body Vitiligo Area Scoring Index [T-VASI]) at week 24, the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50, and T-VASI75 at week 52 and the proportion of patients achieving Vitiligo Noticeability Scale (VNS) score of 4 or 5 at week 24.
Results from both studies demonstrated that ruxolitinib met the primary endpoint with a greater proportion of patients achieving F-VASI75 at week 24 compared with vehicle (P <.0001 for both studies). Additionally, both studies met key secondary endpoints including patient reported outcomes. The safety profile of ruxolitinib cream was consistent with previously reported data, and no new safety signals were observed.
“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, MD, Group Vice President, Inflammation & Autoimmunity, Incyte. “We look forward to working with regulators to bring this much needed treatment option to patients.”
The Company plans to submit a New Drug Application to the Food and Drug Administration in the second half of 2021.
Incyte announces positive results from phase 3 TRuE-V program evaluating ruxolitinib cream in patients with vitiligo. [press release]. Wilmington, DE: Incyte; May 17, 2021.