New data show the Incyte phase 3 TRuE-V clinical trial had positive results in safety and efficacy of ruxolitnib cream for the treatment of.
The treatment is an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy for adolescent and adult patients (≥12 years) with vitiligo.
Each study enrolled 300 patients diagnosed with non-segmental vitiligo.
Patients were required to have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial vitiligo area severity index [F-VASI] score, and at least 3% BSA on nonfacial areas.
They were also required to have ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) up to 10%.
Patients were then randomized into two groups, including 1.5% ruxolitinib cream twice daily (BID) and control for the 24-week double-blind period.
Primary endpoints included the proportion of patients achieving F-VASi75, with at least a 75% improvement from baseline at week 24.
Both the TRuE-V1 and TRuE-V2 met primary endpoints (P <.0001).
The results showed baseline improvement in patients treated with ruxolitnib cream in the facial vitiligo area scoring index (F-VASI75).
Data show a significant patient number treated with ruxolitnib cream 1.5% twice daily resulted in a ≥75% improvement, compared to patients treated with vehicle control at week 24.
Secondary endpoints were met in the trial, including patient reported outcomes.
Both efficacy and safety data were found to be consistent with prior reported phase 2 data, with no new safety signals observed.
Jim Lee, MD, Group Vice President, Inflammation & Autoimmunity at Incyte said in a statement the data confirm the potential of ruxolitnib cream as a meaningful option for patients seeking treatment for vitiligo.
“We look forward to working with regulators to bring this much needed treatment option to patients,” Lee said. “If approved, ruxolitinib cream would be the first and only medical treatment for repigmentation in vitiligo.”
David Rosmarin, MD, Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center noted that vitiligo can have a significant impact quality of life for those suffering from the disease.
“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,” Rosmarin said.
In anat the , Lawrence Eichenfield, MD, of the Rady Children’s Hospital and UC San Diego School of Medicine, noted ruxlitnib treatment “appears to be incredibly well tolerated” by patients with vitiligo.
A marketing application for ruxolitnib cream treatment is planned to be submitted to the US Food and Drug Administration (FDA) in the second half of 2021.