Incyte has reported positive results from a Phase II trial of ruxolitinib cream for the treatment of adult patients aged 18 to 75 with vitiligo, a chronic, immune-mediated skin disease.
The randomised, double-blind, dose-ranging, vehicle-controlled, Phase II study (NCT03099304), which evaluated the safety and efficacy of the nonsteroidal, anti-inflammatory, JAK inhibitor therapy, met its primary endpoint.
The study demonstrated that significantly more patients treated with ruxolitinib cream for a period of 24 weeks achieved a >50% improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with vehicle control (non-medicated cream).
Incyte chief medical officer Steven Stein “The positive 24-week data presented at the World Congress of Dermatology support the potential of ruxolitinib cream to offer a novel treatment option for patients with this chronic autoimmune disease.
“For patients who choose to seek treatment for their vitiligo, current options are often limited by inadequate efficacy or potential side effects.”
The highest F-VASI50 response in the study was achieved with ruxolitinib cream 1.5% once daily (QD) and twice daily (BID) compared to vehicle control.
Incyte noted that Ruxolitinib cream was generally well-tolerated at all dosage strengths.
Based on the positive data, the company plans to initiate the pivotal Phase III development later this year and preparations are currently underway.
The Phase II trial started in April 2017 and consists of three parts spanning 104 weeks.
The study’s primary efficacy endpoint was the percentage of patients treated with ruxolitinib, while key secondary endpoints included the proportion of patients who achieved a F-PhGVA score of zero or one at Week 24 and the safety and tolerability of ruxolitinib.