A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy in Trial Participants With Vitiligo (GREVIT)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Biological: Placebo; Biological: GR2301 injection

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: liaison officer; Phone Number: 021-50805988-8039; Email: shuxueye@genrixbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.
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. Have absolute contraindications to phototherapy; or have relative contraindications to phototherapy (as comprehensively judged by the investigator).
4. 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.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo
Experimental: GR2301 injection dose1/Placebo	Biological: GR2301 injection; IL15 monoclonal antibody
Experimental: GR2301 injection dose2/Placebo	Biological: GR2301 injection; IL15 monoclonal antibody
Experimental: GR2301 injection dose3/Placebo	Biological: GR2301 injection; IL15 monoclonal antibody
Experimental: GR2301 injection dose4	Biological: GR2301 injection; IL15 monoclonal antibody
Experimental: GR2301 injection dose5	Biological: GR2301 injection; IL15 monoclonal antibody
Experimental: GR2301 injection dose6	Biological: GR2301 injection; IL15 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)( Phase Ib）	Incidence of adverse events	up to 52weeks
Proportion of subjects achieving F-VASI 75(Phase II)	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-VASI75 means percentage of subjects with at least a 75% decrease from baseline in F-VASI. The higher the VASI score, the more severe the skin lesion.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline and percent change from baseline in F-VASI/T-VASI	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, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion.	Week 24、36、48、52
Proportion of subjects achieving F/T-VASI 35, 50, and 75	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, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion. F/T-VASI 35, 50, and 75 represent at least a 35%, 50%, or 75% reduction from baseline in either F-VASI or T-VASI.	Week 24、36、48、52
Percent change from baseline in facial body surface area (F-BSA) and total body surface area (T-BSA) affected by vitiligo		Week 24、36、48、52
Proportion of subjects achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA)	The severity of Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA) will be assessed separately by the study physician using the PhGVA, both on a 5-point scale ranging from 0 (clear) to 4 (severe).	Week 24、36、48、52
Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS)	The Vitiligo Noticeability Scale (VNS) is a patient-reported outcome measure of treatment success for vitiligo, using a 5-point scale, where a score of 4 or 5 can be defined as treatment success.	Week 24、36、48、52
Proportion of subjects achieving a score of 1 or 2 on the Facial Patient Global Impression of Change for Vitiligo (F-PaGIC-V) and the Total Patient Global Impression of Change for Vitiligo (T-PaGIC-V)	The Patient Global Impression of Change-Vitiligo (PaGIC-V) is a self-assessment by trial participants of the improvement in facial vitiligo (F-PaGIC-V) and total body vitiligo (T-PaGIC-V), using a 7-point scale, where a PaGIC-V score of 1 or 2 can be defined as treatment success.	Week 24、36、48、52
Incidence of Anti-Drug Antibodys (ADAs)		up to 52weeks
drug concentration		up to 52 weeks

Collaborators and Investigators

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yong Cui, Ph.D, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: IL15
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: GR2301-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No