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

NCT07647237 | Not Yet Recruiting Phase 1

• 1 other identifier: GR2301-002
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Vitiligo

Keywords

IL15

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change from baseline and percent change from baseline in F-VASI/T-VASI

  Week 24、36、48、52

• Proportion of subjects achieving F/T-VASI 35, 50, and 75

  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)

  Week 24、36、48、52

• Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS)

  Week 24、36、48、52

Study Arms (7)

GR2301 injection dose1/Placebo

EXPERIMENTAL

Biological: GR2301 injection

GR2301 injection dose2/Placebo

EXPERIMENTAL

Biological: GR2301 injection

GR2301 injection dose3/Placebo

EXPERIMENTAL

Biological: GR2301 injection

GR2301 injection dose4

EXPERIMENTAL

Biological: GR2301 injection

GR2301 injection dose5

EXPERIMENTAL

Biological: GR2301 injection

GR2301 injection dose6

EXPERIMENTAL

Biological: GR2301 injection

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

GR2301 injection BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection dose1/Placebo; GR2301 injection dose2/Placebo; GR2301 injection dose3/Placebo; GR2301 injection dose4; GR2301 injection dose5; GR2301 injection dose6

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yong Cui, Ph.D

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

liaison officer

CONTACT

021-50805988-8039; shuxueye@genrixbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share