A Phase 2 Study of D-2570 in Subjects With Non-Segmental Vitiligo

Overview

This study tests D-2570, an investigational drug, in people with non-segmental vitiligo to check its safety and effect on skin discoloration. Eligible participants will take D-2570, or a placebo, once daily for 24 weeks in a double-blind setting. Most will then continue into a 24-week extension phase, where those on 27 mg or placebo will switch to one of the lower doses. All participants will have a 4-week safety follow-up after treatment ends, with regular check-ups and blood tests throughout the study.

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of D-2570 in subjects with non-segmental vitiligo. The study consists of three periods: a screening period (up to 4 weeks), a 24-week double-blind treatment period, and a 24-week extension treatment period, followed by a 4-week safety follow-up period. During the screening period, written informed consent will be obtained from each subject, and eligibility will be assessed based on predefined inclusion and exclusion criteria. Subjects who meet all eligibility criteria will be stratified according to baseline vitiligo severity (T-VASI \<15 or ≥15) and disease activity (active or stable), then randomized in a 1:1:1:1 ratio to one of four treatment groups: D-2570 9 mg QD (Group A), D-2570 18 mg QD (Group B), D-2570 27 mg QD (Group C), or placebo. During the 24-week double-blind treatment period, subjects will receive once-daily oral study medication. Subjects in Groups A and B will continue the same dose in the subsequent 24-week extension period. Subjects in Group C and the placebo group will be re-randomized in a 1:1 ratio to either D-2570 9 mg QD or 18 mg QD for the extension period, maintaining the blind. All subjects will attend study visits at protocol-specified time points, including assessments of efficacy (including T-VASI), safety (including adverse events, clinical laboratory tests, vital signs, and physical examinations), and pharmacokinetic evaluations via blood sampling. The study will conclude with an end-of-study (EOS) visit at Week 52, 4 weeks after the last dose of study medication, to collect final safety data. All subjects, investigators, and study site personnel will remain blinded to treatment assignments throughout the study.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

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