Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo
A Multicenter, Randomized, Double-blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Non-segmental Vitiligo
1 other identifier
interventional
120
1 country
1
Brief Summary
This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
September 15, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
January 2, 2026
December 1, 2025
1.8 years
September 8, 2025
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change in facial vitiligo area score index (F-VASI) relative to baseline at week 24
Week 24
Study Arms (3)
VC005 Tablets Low Dose groups
EXPERIMENTALVC005 Tablets High Dose groups
EXPERIMENTALVC005 Tablets Placebo groups
PLACEBO COMPARATORInterventions
VC005 groups repeat administration for 52 weeks
VC005 Placebo groups repeat administration for 52 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Peking University People's Hospital
Beijing, Beijng, China
Central Study Contacts
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
September 8, 2025
First Posted
September 15, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12