Phase II Clinical Study of VC005 Tablets in Subjects With Severe Alopecia Areata

August 25, 2026 updated by: Jiangsu vcare pharmaceutical technology co., LTD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Severe Alopecia Areata

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of VC005 tablets in subjects with severe alopecia areata (AA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

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
        • Recruiting
        • The Peking University People's Hospital, Beijing, Beijng
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects must fully understand the study, be willing and able to comply with all trial procedures, voluntarily participate in the clinical trial, and provide written informed consent by signing the informed consent form (ICF).
  • Subjects must be aged between 18 and 65 years (inclusive) at the time of ICF signing, regardless of gender.
  • Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding, or subjects who plan to become pregnant or breastfeed during the study period.
  • Subjects with a current diagnosis of acute diffuse alopecia areata (AA).
  • Subjects with a current diagnosis of other types of alopecia that may interfere with the evaluation of AA, including but not limited to traction alopecia, cicatricial alopecia, telogen effluvium, androgenetic alopecia, syphilitic alopecia, anagen effluvium, folliculotropic mycosis fungoides, or alopecia caused by thyroid disease, etc.
  • Subjects with other scalp diseases that may affect the assessment of AA, such as scalp psoriasis, dermatitis, tinea capitis, etc.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC005 Tablets Low Dose group
Drug: Drug: VC005 tablets
VC005 repeat administration for 24 weeks
Experimental: VC005 Tablets High Dose group
Drug: VC005 tablets
VC005 repeat administration for 24 weeks
Placebo Comparator: VC005 Tablets placebo group
Drug: VC005 placebo tablets
VC005 placebo repeat administration for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with a Severity of Alopecia Tool (SALT) score ≤ 20
Time Frame: at Week 24 (W24)
at Week 24 (W24)

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: jianzhong Zhang, The Peking University People's Hospital, Beijing, Beijng
  • Principal Investigator: cheng zhou, The Peking University People's Hospital, Beijing, Beijng

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 (Actual)

August 18, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

August 3, 2026

First Submitted That Met QC Criteria

August 3, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC005-206

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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