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).
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.
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.
Parallel
GR2301 injection
Biological/VaccineIL15 monoclonal antibody
Placebo
Biological/VaccinePlacebo
7
Treatment groupsSee each treatment group below.
Adverse events (AEs)( Phase Ib）
Incidence of adverse events
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.
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.
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.
Percent change from baseline in facial body surface area (F-BSA) and total body surface area (T-BSA) affected by vitiligo
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).
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