TRIAL SUCCESS

InnoCare's soficitinib clears Phase II vitiligo endpoint versus placebo

Both oral doses of the TYK2 inhibitor beat placebo on facial repigmentation at Week 24, setting up a Phase III test in a disease with no approved systemic drug of this class.

By AppliedXLJuly 16, 2026Trial NCT07047612

Executive Summary

The Phase II portion of a Phase II/III trial testing an oral TYK2 inhibitor in non-segmental vitiligo met its primary endpoint, with a clear dose-dependent separation from placebo on facial repigmentation.
The endpoint measured percent improvement in a standardized facial vitiligo severity score at 24 weeks, a validated but intermediate marker in a chronic autoimmune skin disease that currently has no approved systemic drug.
The drug was reported as well tolerated with no new safety signals, consistent with prior studies of the same molecule in other indications.
The positive Phase II result lets the trial's built-in Phase III portion proceed under the same protocol, moving toward a harder endpoint and a longer follow-up before the program can support a marketing application.
The result lands in a sparse field: only a handful of drugs are in mid-to-late clinical testing for this specific indication, and the two most advanced peer programs work through different mechanisms, leaving the readout as one of the more mature signals in an area still without a validated systemic therapy.

The result

InnoCare Pharma reported that soficitinib, an oral TYK2 inhibitor (a Janus kinase pathway enzyme involved in inflammatory signaling), met the primary endpoint of the Phase II portion of trial NCT07047612 in adults and adolescents with non-segmental vitiligo. The least-squares mean percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI), a standard measure of facial pigment loss, was 38.8% in the 80 mg once-daily arm and 41.2% in the 120 mg once-daily arm at Week 24, compared with 2.2% in the placebo arm. Both doses separated from placebo at P<0.0001. "We are delighted that the Phase II clinical trial of soficitinib for vitiligo has met the primary endpoint," said Jasmine Cui, InnoCare's co-founder, chairwoman and chief executive. InnoCare

Probability of Success

Endpoint Met96%

Completes98%

Clinical Significance20%

Regulatory69%

The design

The trial is a randomized, double-blind, placebo-controlled, adaptive Phase II/III study run across five arms with quadruple masking, enrolling 603 patients in China. It is structured as a Phase II portion feeding directly into a Phase III portion under the same protocol, with the Phase II primary endpoint set as percent change in F-VASI at Week 24 and the Phase III primary endpoint set as the proportion of patients achieving F-VASI75 at Week 52. Eligible patients had at least 5% total body surface area involvement, at least 0.5% facial surface area involvement, and active or stable disease for at least three months. The registered primary completion date is April 2029, and the trial remains listed as recruiting. NCT07047612

Safety

InnoCare described soficitinib's safety profile as favorable and consistent with prior studies of the drug, reporting no new safety signals and describing the treatment as well tolerated. The company did not disclose adverse-event rates by arm in the announcement. InnoCare

The competitive setting

Vitiligo has no approved systemic drug validated for disease-wide use, and the indication-landscape search around this trial surfaced eight trials, spanning early-stage JAK-pathway assets from Chinese sponsors, a Phase IIb dose-ranging study of Novartis's GIA632, AbbVie's Phase III trial of upadacitinib, and Minghui Pharmaceutical's Phase III MH004 ointment, none of which shares soficitinib's specific target or is designed as a direct head-to-head comparator. AbbVie's upadacitinib trial, the most advanced peer program in Phase III, was flagged with a high registry risk score tied to update gaps in its record, while InnoCare's own program carries a low risk score with a single dormancy flag tied to routine registry inactivity rather than any enrollment or endpoint problem. Against a field where no comparator has yet delivered a validated systemic result in this specific population, a Phase III read that reproduces this dose-response signal on the harder F-VASI75 endpoint at Week 52, in a larger and more diverse population, would be the evidence that distinguishes soficitinib within the field.

The stake ahead

The Phase III portion, using the higher bar of F-VASI75 (75% facial repigmentation) at Week 52 instead of percent change at Week 24, will determine whether the effect holds over a full year and translates into the kind of clinically pronounced repigmentation regulators and physicians look for. InnoCare said detailed efficacy and safety results, including secondary measures, will be presented at a scientific congress or in a journal publication rather than disclosed in full in the announcement. NCT07047612+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.