Overview
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.
Description
This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.
Eligibility
Inclusion Criteria:
- 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
- ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5
- ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60
Exclusion Criteria:
- 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
- Use of prohibited medication \& treatments. Other protocol-defined inclusion/exclusion criteria may apply
