Ruxolitinib cream improves facial vitiligo in phase 3 trials
Ruxolitinib cream improved facial vitiligo and showed positive patient-reported outcomes in a phase 3 clinical trial program, Incyte announced in a press release.
The TRuE-V1 and TRuE-V2 studies evaluated the investigational, nonsteroidal, anti-inflammatory JAK inhibitor in patients aged 12 years and older with vitiligo.
Each study included approximately 300 patients who were randomly assigned to receive ruxolitinib cream 1.5% twice daily or vehicle cream for 24 weeks.
An improvement of at least 75% in facial Vitiligo Area Scoring Index (F-VASI) from baseline was the primary endpoint of both studies.
More patients in the treatment arms reached this endpoint than those in the vehicle arms (P < .0001 for both studies), the release said. In addition, ruxolitinib also met secondary endpoints including patient-reported outcomes and improvement in total body Vitiligo Area Scoring Index and body surface area.
“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,” Jim Lee, MD, group vice president of inflammation and autoimmunity at Incyte, said in the release. “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.”
The company plans to submit marketing applications to the FDA and European Medicines Agency later this year based on these data.