Non-Segmental Vitiligo
Conditions
Brief summary
This study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo
Interventions
DRUGVC005 tablets
VC005 repeat administration for up to 24 weeks
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* The subject fully understands this study and is able to comply with the relevant trial procedures. The subject and their legal guardian voluntarily sign the informed consent form (ICF). * Age 12 to 18 years inclusive (including 12 years old, excluding 18 years old) at the time of signing the ICF, both genders, with body weight ≥ 30 kg. * Subjects with a clinical diagnosis of non-segmental vitiligo
Exclusion criteria
* Pregnant or breastfeeding women, or subjects planning to become pregnant or breastfeed during the study period. * Trial participants with complete depigmentation of hair within the vitiligo area. * Trial participants clinically diagnosed with segmental vitiligo, mucosal non-segmental vitiligo, or other cutaneous depigmentation disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC） | Day1，Day28 |
| Peak Plasma Concentration (Cmax） | Day1，Day28 |
Countries
China
Contacts
CONTACTxiaojuan Lai
PRINCIPAL_INVESTIGATORJianzhong Zhang Zhang
The Peking University People's Hospital
PRINCIPAL_INVESTIGATORcheng zhou
The Peking University People's Hospital
Outcome results
None listed