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Not yet recruiting NCT07647237

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

Phase I / Phase II Interventional Vitiligo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GR2301 injection, Placebo.
Who it may be relevant to
Registry conditions: Vitiligo. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Biological GR2301 injection
    IL15 monoclonal antibody
  • Biological Placebo
    Placebo

Primary outcome measures

  • Adverse events (AEs)( Phase Ib） [Time frame: up to 52weeks]
  • Proportion of subjects achieving F-VASI 75(Phase II) [Time frame: Week 24]
Secondary outcome measures (8)
  • Change from baseline and percent change from baseline in F-VASI/T-VASI [Time frame: Week 24、36、48、52]
  • Proportion of subjects achieving F/T-VASI 35, 50, and 75 [Time frame: 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 [Time frame: 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) [Time frame: Week 24、36、48、52]
  • Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) [Time frame: 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) [Time frame: Week 24、36、48、52]
  • Incidence of Anti-Drug Antibodys (ADAs) [Time frame: up to 52weeks]
  • drug concentration [Time frame: up to 52 weeks]

Eligibility criteria

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07647237 · GR2301-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗