InnoCare’s oral TYK2 inhibitor soficitinib met the primary endpoint in a Phase II/III vitiligo trial, showing significant facial repigmentation and favorable safety.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
InnoCare Pharma reported positive Phase II results from the adaptive Phase II/III clinical trial (NCT07047612) of its oral TYK2 inhibitor soficitinib (ICP-332) in patients with non-segmental vitiligo, with both evaluated dose groups meeting the study’s primary endpoint. The findings strengthen the company’s dermatology pipeline and support progression into the Phase III portion of the registrational study.
Soficitinib Demonstrates Significant Repigmentation Benefit
The ongoing study is a randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter Phase II/III trial evaluating soficitinib in patients with non-segmental vitiligo. The trial begins with a dose-finding Phase II stage before transitioning into Phase III.
At Week 24, patients receiving soficitinib achieved statistically significant improvements in facial skin repigmentation compared with placebo, as measured by the Facial Vitiligo Area Scoring Index (F-VASI), the study’s primary endpoint.
The least-squares mean percentage change from baseline in F-VASI reached 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo arm. Both treatment groups demonstrated highly significant improvements over placebo (P<0.0001).
Favorable Safety Profile Supports Continued Development
Soficitinib was generally well tolerated throughout the study. The safety profile remained consistent with previous clinical investigations, and investigators reported no new safety signals.
The company stated that comprehensive efficacy and safety analyses will be presented at upcoming international scientific meetings and submitted for publication in peer-reviewed medical journals.
TYK2 Inhibition Targets Immune Pathways Driving Vitiligo
Soficitinib is a potent, selective oral tyrosine kinase 2 (TYK2) inhibitor under development for multiple T-cell-mediated autoimmune diseases. TYK2 is a key component of the JAK-STAT signaling pathway and regulates inflammatory cytokine signaling involved in several immune-mediated disorders.
Beyond vitiligo, the drug is also being investigated for atopic dermatitis, psoriasis, nodular prurigo, and chronic spontaneous urticaria, positioning it as a potential broad dermatology therapy.
Vitiligo develops when immune-mediated destruction of melanocytes causes depigmented patches on the skin. The chronic disorder affects an estimated 0.5% to 2% of the global population and often requires long-term treatment to stabilize disease activity, restore pigmentation, and reduce recurrence.
Company Highlights Clinical Potential
Dr. Jasmine Cui, Co-founder, Chairwoman and Chief Executive Officer of InnoCare Pharma, said the positive Phase II findings represent an important milestone for the development program. She noted that the company believes soficitinib has the potential to offer patients with vitiligo an oral treatment option that combines meaningful efficacy with a favorable safety profile and convenient once-daily administration.
Phase III Development Advances
Completion of the successful Phase II portion allows the adaptive study to advance toward its Phase III stage. If subsequent data confirm the current efficacy and safety findings, soficitinib could emerge as a new oral therapeutic option for patients with non-segmental vitiligo, a disease with limited long-term treatment choices.
The results also expand the growing clinical evidence supporting TYK2 inhibition as a targeted strategy for immune-mediated skin disorders, reinforcing InnoCare’s broader development program across multiple autoimmune dermatologic indications.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.