A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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 expo