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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07749716

Enrollment

120

Registered

2026-08-06

Start date

2026-08-18

Completion date

2028-12-30

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Brief summary

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).

Interventions

DRUGDrug: VC005 tablets

VC005 repeat administration for 24 weeks

DRUGVC005 tablets

VC005 repeat administration for 24 weeks

DRUGVC005 placebo tablets

VC005 placebo repeat administration for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

CONTACTxiaojuan Lai

lai_xiaojuan@vcarepharmatech.com+8615358160458

PRINCIPAL_INVESTIGATORjianzhong Zhang

The Peking University People's Hospital, Beijing, Beijng

PRINCIPAL_INVESTIGATORcheng zhou