A Phase 2 interventional study of GR2301 injection and Placebo in Vitiligo, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 2, Interventional, and Treatment
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 120 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: GR2301 injection
Biological: GR2301 injection
Biological: GR2301 injection
Biological: Placebo
IL15 monoclonal antibody
Placebo
Proportion of trial participants achieving F-VASI50 at the Week 24 (W24) visit.
VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions. F-VASI50 means percentage of subjects with at least a 50% decrease from baseline in F-VASI. The higher the VASI score, the more severe the skin lesion.
Time frame: Week 24
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GR2301
Genrix (Shanghai) Biopharmaceutical Co., Ltd. →