Beijing, July 16, 2026
InnoCare Pharma announced that the Phase II portion of its adaptive Phase II/III clinical trial evaluating soficitinib (ICP-332) for the treatment of non-segmental vitiligo successfully met its primary endpoint. The randomized, double-blind, placebo-controlled multicenter study demonstrated statistically significant improvements in facial skin repigmentation after 24 weeks of treatment, supporting continued advancement into the Phase III portion of the trial.
Significant Improvement in Facial Vitiligo Scores
At Week 24, patients receiving 80 mg and 120 mg once-daily doses of soficitinib achieved substantial improvements in the Facial Vitiligo Area Scoring Index (F-VASI) compared with placebo. The least-squares mean percentage improvement from baseline reached 38.8% in the 80 mg group and 41.2% in the 120 mg group, versus 2.2% in the placebo arm, with both treatment groups demonstrating highly significant statistical superiority (P<0.0001).
Favorable Safety Profile Supports Continued Development
The study also confirmed a favorable safety profile for soficitinib, with results consistent with previous clinical studies. The oral TYK2 inhibitor was well tolerated throughout the trial, and investigators reported no new safety signals. Detailed efficacy and safety findings are expected to be presented at upcoming international scientific conferences and published in peer-reviewed journals.
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TYK2 Inhibitor Targets Multiple Autoimmune Skin Diseases
Soficitinib is a potent, selective oral TYK2 inhibitor designed to modulate the JAK-STAT signaling pathway, a key driver of inflammatory and autoimmune diseases. Beyond vitiligo, InnoCare is developing the therapy for several dermatologic conditions, including atopic dermatitis, psoriasis, nodular prurigo, and chronic spontaneous urticaria. Positive Phase II results strengthen the program’s potential to provide a convenient oral treatment option for patients with chronic autoimmune skin disorders requiring long-term disease management.
Source: InnoCare Pharma,press release
