Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07647237

A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy 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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GR2301 injection

Biological

IL15 monoclonal antibody

Placebo

Biological

Placebo

Primary outcomes

  1. Adverse events (AEs)( Phase Ib）

    Time frame: up to 52weeks

    Incidence of adverse events

  2. Proportion of subjects achieving F-VASI 75(Phase II)

    Time frame: Week 24

    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.

Secondary outcomes

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

    Time frame: Week 24、36、48、52

    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.

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

    Time frame: Week 24、36、48、52

    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.

  3. 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

  4. 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

    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).

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

    Time frame: Week 24、36、48、52

    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.

  6. 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

    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.

  7. Incidence of Anti-Drug Antibodys (ADAs)

    Time frame: up to 52weeks

  8. drug concentration

    Time frame: up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

liaison officer

CONTACT

[email protected]

021-50805988-8039

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: GREVIT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.