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

NCT07647237 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-06-15

No results posted yet for this study

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

Interventions

BIOLOGICAL

GR2301 injection

IL15 monoclonal antibody

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Genrix (Shanghai) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yong Cui, Ph.D · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647237 on ClinicalTrials.gov