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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Drug: VC005 tablets
  • VC005 tablets
  • VC005 placebo tablets

Treatment groups

120 Participants
are divided into 3 treatment groups