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

NCT07749716 | Not Yet Recruiting Phase 2

• 1 other identifier: VC005-206
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

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

  at Week 24 (W24)

Study Arms (3)

VC005 Tablets Low Dose group

EXPERIMENTAL

Drug: Drug: VC005 tablets

VC005 Tablets High Dose group

EXPERIMENTAL

Drug: VC005 tablets

VC005 Tablets placebo group

PLACEBO COMPARATOR

Drug: VC005 placebo tablets

Interventions

Drug: VC005 tablets DRUG

VC005 repeat administration for 24 weeks

VC005 Tablets Low Dose group

VC005 tablets DRUG

VC005 repeat administration for 24 weeks

VC005 Tablets High Dose group

VC005 placebo tablets DRUG

VC005 placebo repeat administration for 24 weeks

VC005 Tablets placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The Peking University People's Hospital, Beijing, Beijng

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

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

Study Officials

• jianzhong Zhang

  The Peking University People's Hospital, Beijing, Beijng

  PRINCIPAL INVESTIGATOR

• cheng zhou

  The Peking University People's Hospital, Beijing, Beijng

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan Lai

CONTACT

+8615358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

CN (1)