RecruitingPhase 2

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Non-Segmental Vitiligo

China200 participantsStarted 2025-11-05

Plain-language summary

To evaluate the efficacy of QY201 Tablets in adult subjects with non-segmental vitiligo, and to provide evidence for dose selection in the confirmatory Phase III clinical trial.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The subject is able to communicate well with investigators, fully understands the purpose, nature, methods and potential adverse reactions of this trial, voluntarily participates as a study subject, comprehends and complies with all requirements of this research, and signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
. At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
. Clinically diagnosed with non-segmental vitiligo at screening.
. Subjects must meet the following criteria at screening and baseline:
. The subject (and partner if applicable) agrees to avoid pregnancy and adopt effective contraceptive measures from ICF signature through 3 months after the last study drug administration.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment.

Timeframe: Week 24 of protocol-specified treatment

Trial details

NCT IDNCT07712523

SponsorE-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Li Qiang

86-15957643460 qiang.li@enitiatebio.com

View on ClinicalTrials.gov More Adult Subjects With Non-Segmental Vitiligo trials