A Study of VC005 Tablets in Adolescent Subjects With Non-Segmental Vitiligo

September 15, 2026 updated by: Jiangsu vcare pharmaceutical technology co., LTD

A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Non-Segmental Vitiligo

This study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • The Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang
          • Phone Number: 010-88325471
          • Email: rmzjz@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The subject fully understands this study and is able to comply with the relevant trial procedures. The subject and their legal guardian voluntarily sign the informed consent form (ICF).
  • Age 12 to 18 years inclusive (including 12 years old, excluding 18 years old) at the time of signing the ICF, both genders, with body weight ≥ 30 kg.
  • Subjects with a clinical diagnosis of non-segmental vitiligo

Exclusion Criteria:

  • Pregnant or breastfeeding women, or subjects planning to become pregnant or breastfeed during the study period.
  • Trial participants with complete depigmentation of hair within the vitiligo area.
  • Trial participants clinically diagnosed with segmental vitiligo, mucosal non-segmental vitiligo, or other cutaneous depigmentation disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC005 Tablets
Drug: VC005 tablets
VC005 repeat administration for up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time Frame: Day1，Day28
Day1，Day28
Peak Plasma Concentration (Cmax）
Time Frame: Day1，Day28
Day1，Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Investigators

  • Principal Investigator: cheng zhou, The Peking University People's Hospital
  • Principal Investigator: Jianzhong Zhang Zhang, The Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • VC005-113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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