D-2570 in Non-Segmental Vitiligo (Phase 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating the safety and efficacy of D-2570 in adults with non-segmental vitiligo. Participants are randomized 1:1:1:1 to D-2570 at three dose levels or placebo for 24 weeks, with an additional 24-week extension for some groups and a 4-week safety follow-up. The study includes stratification by baseline severity and disease activity, regular safety labs, and pharmacokinetic assessments. Efficacy is measured using skin pigmentation scales such as the T-VASI, alongside safety monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: shilin Sha
• Email: shilin.sha@inventisbio.com
• Phone: 15601826678

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.