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

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: VC005 Tablets Low Dose groupExperimental treatment 1 intervention
Group B: VC005 Tablets High Dose groupExperimental treatment 1 intervention
Group C: VC005 Tablets placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at Week 24 (W24)

Secondary outcomes

Other outcomes

Sponsors and contacts

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