A Clinical Trial of Multiple Doses of GR2301 Injection in Participants With Vitiligo.

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

120 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a Phase II, randomized, double-blind, placebo-controlled clinical trial of multiple subcutaneous administrations of GR2301 Injection to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics in trial participants with vitiligo. Eligible trial participants will be randomized using stratified block randomization, with competitive enrollment across sites; they will be assigned to the experimental group or the control group in the order of successful screening.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Main Inclusion Criteria:

1. Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of vitiligo for at least 3 months at screening visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit.
2. 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.

Main Exclusion Criteria:

1. Vitiligo-related medical conditions and other dermatologic diseases/conditions.
2. Prior permanent tattooing or grafting within the vitiligo lesions.
3. 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.
4. 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Study start

2026-11 Estimated

Primary completion

2028-05 Estimated

Study completion

2028-11 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts