A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy in Trial Partic… (NCT07647237) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy in Trial Participants With Vitiligo
116 participantsStarted 2026-06
Plain-language summary
This is a randomized, double-blind, placebo-controlled Phase Ib/II clinical trial of multiple subcutaneous injections of GR2301 in combination with phototherapy to evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy in trial participants with vitiligo. The trial will be conducted in two stages: a dose-escalation stage (Phase Ib) and an expansion cohort stage (Phase II).
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
. Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of non-segmental vitiligo for at least 3 months at screening visit; facial affected BSA ≥0.5% and total body affected BSA ≥3% at screening visit and baseline visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit.
. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and provide signed written informed consent by the trial participant or their legally authorized representative.
Exclusion criteria
. Vitiligo-related medical conditions and other dermatologic diseases/conditions.
. Prior permanent tattooing or grafting within the vitiligo lesions.
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
1
Adverse events (AEs)( Phase Ib）
Timeframe: up to 52weeks
2
Proportion of subjects achieving F-VASI 75(Phase II)
. Have absolute contraindications to phototherapy; or have relative contraindications to phototherapy (as comprehensively judged by the investigator).
. Are unwilling or unable to comply with the permitted and prohibited concomitant medications/treatment specifications of this trial, and cannot meet the protocol-required washout period for medications/treatments prior to randomization.
. Have a serious underlying disease that, in the investigator's opinion, may pose a safety risk to the trial participant if enrolled in the clinical trial.