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A Phase 2 Multicenter, Randomized, Parallel-group, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 in Subjects With Non-Segmental Vitiligo
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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 All participants will have a 4-week safety follow-up after treatment ends, with regular check-ups and blood tests throughout the study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Voluntarily signs informed consent and complies with study procedures.
• Age 18-65 years, male or female.
• Clinical diagnosis of non-segmental vitiligo at screening.
• F-VASI ≥0.25 and T-VASI ≥5 at screening and baseline, with either active or stable vitiligo.
• Women of childbearing potential have negative pregnancy tests at screening and baseline. All eligible subjects agree to effective contraception from consent through 30 days after last study drug dose.
Locations
Other Locations
China
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
shilin Sha
shilin.sha@inventisbio.com
15601826678
Time Frame
Start Date:2026-06-11
Estimated Completion Date:2028-05
Participants
Target number of participants:160
Treatments
Experimental: D-2570 Dose 1 (experimental arm 1)
Subjects in this arm will receive oral D-2570 Dose 1 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 1 in the subsequent 24-week extension period.
Experimental: D-2570 Dose 2 (experimental arm 2)
Subjects in this arm will receive oral D-2570 Dose 2 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 2 in the subsequent 24-week extension period
Experimental: D-2570 Dose 3 (experimental arm 3)
Subjects in this arm will receive oral D-2570 Dose 3 once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period.
Placebo_comparator: placebo
Subjects in this arm will receive matching placebo once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period.