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NCT Number: NCT07749716

Phase II Clinical Study 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).

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Peking University People's Hospital, Beijing, Beijng

Beijing, Beijing Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug: VC005 tablets

Drug

VC005 repeat administration for 24 weeks

VC005 tablets

Drug

VC005 repeat administration for 24 weeks

VC005 Placebo tablets

Drug

VC005 placebo repeat administration for 24 weeks

Primary outcomes

  1. Proportion of subjects with a Severity of Alopecia Tool (SALT) score ≤ 20

    Time frame: at Week 24 (W24)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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