Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo

Jiangsu Vcare PharmaTech

Status and phase: Begins enrollment this month; Phase 2

Conditions: Non-segmental Vitiligo

Treatments: Drug: VC005 Tablets Placebo; Drug: VC005 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07172347

VC005-204

Details and patient eligibility

About

This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol.
• The subject is between 18 and 70 years of age (including borderline values) , regardless of gender.

Exclusion criteria

• Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
• All hair in the vitiligo area on the face is white.
• Those who are known or suspected to be allergic to the main ingredients and excipients of VC005 or similar drugs.
• Subjects who have previously received depigmentation treatment.
• Subjects who have received experimental drug administration or participated in device clinical trials within the first month or 5 half lives (whichever is longer) prior to randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

VC005 Tablets Low Dose groups

Experimental group

Treatment:

Drug: VC005 tablets

VC005 Tablets High Dose groups

Experimental group

Treatment:

Drug: VC005 tablets

VC005 Tablets Placebo groups

Placebo Comparator group

Treatment:

Drug: VC005 Tablets Placebo