A Phase 2 Study of D-2570 in Subjects With Non-Segmental Vitiligo (D2570-206)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo; Non-Segmental Vitiligo (NSV)
• Intervention / Treatment: Drug: D-2570 9mg; Drug: D-2570 18mg; Drug: D-2570 27mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: shilin Sha, project manager; Phone Number: 15601826678; Email: shilin.sha@inventisbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201203
      • Huashan Hospital, Fudan University
      • Contact: shilin Sha; Phone Number: 15601826678; Email: shilin.sha@inventisbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - Segmental, mixed vitiligo or other concurrent pigmentary/active skin disorders interfering with study assessment.
• Over 33% facial or total vitiligo lesions with leukotrichia.
• Pregnant or breastfeeding females.
• Active, latent or inadequately treated tuberculosis infection.
• Positive HIV, active HBV/HCV infection, or untreated syphilis.
• Current or history of severe herpes infection.
• Severe systemic infection requiring recent inpatient, intravenous or oral anti-infective treatment.
• Congenital or acquired immune deficiency, opportunistic infection history, or conditions requiring systemic immunosuppression during the study.
• Uncontrolled thyroid disease, severe cardiovascular/cerebrovascular disease or other unstable severe systemic disorders.
• Severe psychiatric disease, suicidal ideation, or alcohol/drug abuse within 6 months.
• Malignancy history within 5 years (excluding cured non-melanoma skin cancer and cervical intraepithelial neoplasia).
• Gastrointestinal disease affecting drug absorption or major surgery within 8 weeks prior to dosing.
• Clinically significant abnormal lab results: elevated liver/renal indices, decreased hemoglobin, WBC, platelet, lymphocyte or neutrophil counts.
• History of severe drug hypersensitivity or drug-related toxicity.
• Any condition that may impair protocol compliance or study participation per investigator judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-2570 9 mg (experimental arm 1); Subjects in this arm will receive oral D-2570 9 mg once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 9 mg in the subsequent 24-week extension period.	Drug: D-2570 9mg; Oral D-2570 9 mg administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period
Experimental: D-2570 18 mg (experimental arm 2); Subjects in this arm will receive oral D-2570 18 mg once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 18 mg in the subsequent 24-week extension period	Drug: D-2570 18mg; Oral D-2570 18 mg administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period.
Experimental: D-2570 27 mg (experimental arm 3); Subjects in this arm will receive oral D-2570 27 mg once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 9 mg or 18 mg once daily for the extension period.	Drug: D-2570 27mg; Oral D-2570 27 mg administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 9 mg or 18 mg in 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 9 mg or 18 mg once daily for the extension period.	Drug: Placebo; Oral placebo administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 9 mg or 18 mg in the extension period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI)	Change rate of facial vitiligo area, measured by F-VASI score, relative to baseline	week24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change and percentage change from baseline in F-VASI	Absolute change and percentage change in facial vitiligo area, measured by F-VASI score, relative to baseline.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving F-VASI50/75/90	Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in F-VASI score from baseline.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Change and percentage change from baseline in T-VASI	Absolute change and percentage change in total vitiligo area, measured by T-VASI score, relative to baseline.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving T-VASI50/75/90	Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in T-VASI score from baseline.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects with F-PhGVA score 0 or 1	Percentage of subjects with F-PhGVA score of 0 (clear) or 1 (almost clear).	Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with T-PhGVA score 0 or 1	Percentage of subjects with T-PhGVA score of 0 (clear) or 1 (almost clear).	Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with VNS score 4 or 5	Percentage of subjects with VNS score of 4 (hardly noticeable) or 5 (not noticeable).	Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in DLQI score	Change in Dermatology Quality of Life Index (DLQI) score relative to baseline.	Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in VitiQoL score	Change in Vitiligo-Specific Quality of Life (VitiQoL) score relative to baseline.	Weeks 8, 16, 24, 32, 40, and 48
Plasma concentrations of D-2570		Through study completion (approximately Week 48)
Safety of D-2570（AEs）		Through study completion (approximately Week 48)

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase 2 Clinical Trial; Non-segmental Vitiligo; D-2570
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: D2570-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No