Incyte Announces Positive Results from a Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo
Incyte (Nasdaq:INCY) today announces 24-week results from its randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients (18 to 75 years of age) with vitiligo. The study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50 percent improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with a vehicle control (non-medicated cream). F-VASI50 response was most notably achieved with ruxolitinib cream 1.5 percent administered once daily (QD) and twice daily (BID) vs. vehicle control (50 percent and 45 percent vs. 3 percent, respectively; P<0.001).
These results are being presented at the 24th World Congress of Dermatology (WCD) in Milan, Italy, during a late-breaking research session today, June 15, 2019, from 9:25 a.m. CET to 9:35 a.m. CET (3:25 a.m. EDT to 3:35 a.m. EDT). (Location: Room Yellow 3).
“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,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “For patients who choose to seek treatment for their vitiligo, current options are often limited by inadequate efficacy or potential side effects. We look forward to advancing ruxolitinib cream into Phase 3 development for vitiligo in the hope that it may become the first approved treatment for what can be a life-altering disease.”
Key 24-week results include:
- Significantly more patients achieved F-VASI50 after 24 weeks of treatment with all ruxolitinib cream regimens compared to the vehicle control. The highest F-VASI50 response was achieved with ruxolitinib cream 1.5 percent QD and BID compared to vehicle control (50 percent and 45 percent vs. 3 percent, respectively; P<0.001).
- A ≥75 percent improvement from baseline in the facial vitiligo area severity index score was achieved by 17 percent, 30 percent, and 0 patients treated with ruxolitinib cream 1.5 percent QD, BID, and vehicle cream, respectively.
- Facial Physician Global Vitiligo Assessment (F-PhGVA) scores of clear (no signs of vitiligo) or almost clear (only specks of depigmentation present) skin were achieved by 13 percent, 9 percent, and 0 patients receiving ruxolitinib cream 1.5 percent QD, BID, and vehicle cream, respectively.
- Ruxolitinib cream was generally well-tolerated at all dosage strengths.
Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. These data on ruxolitinib cream, a JAK inhibitor, support the planned initiation of pivotal Phase 3 development later in 2019, for which preparations are already underway.