About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- GIA632
- Placebo