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

NCT07625891 | Not Yet Recruiting Phase 2

• 1 other identifier: D2570-206
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Vitiligo; Non-Segmental Vitiligo (NSV)

Keywords

Non-segmental Vitiligo; D-2570; Phase 2 Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change and percentage change from baseline in F-VASI

  Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Proportion of subjects achieving F-VASI50/75/90

  Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Change and percentage change from baseline in T-VASI

  Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Proportion of subjects achieving T-VASI50/75/90

  Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Proportion of subjects with F-PhGVA score 0 or 1

  Weeks 8, 16, 24, 32, 40, and 48

Study Arms (4)

D-2570 9 mg (experimental arm 1)

EXPERIMENTAL

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

D-2570 18 mg (experimental arm 2)

EXPERIMENTAL

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

D-2570 27 mg (experimental arm 3)

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

D-2570 9mg DRUG

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

D-2570 9 mg (experimental arm 1)

D-2570 18mg DRUG

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.

D-2570 18 mg (experimental arm 2)

Placebo DRUG

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.

placebo

D-2570 27mg DRUG

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.

D-2570 27 mg (experimental arm 3)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

shilin Sha, project manager

CONTACT

15601826678; shilin.sha@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment throughout the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 4, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)