The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.
Signed informed consent must be obtained prior to participation in the study
Male or female as assigned at birth ≥ 18 years of age at the time of screening
Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
Non-segmental vitiligo, as assessed at screening, as
Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations [such as piebaldism, Waardenburg, etc.], chemical- or druginduced leukoderma, etc.)
Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
Individual who previously attempted or completed depigmentation therapy for NSV
Parallel
GIA632
DrugGIA632 will be administered during the 48-week core period.
Placebo
DrugPlacebo will be administered during the 48-week core period.
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.
T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body.
Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)
T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body.
Achievement of F-VASI50, F-VASI75, and FVASI90
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. F-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the facial vitiligo area scoring index (F-VASI), respectively.
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