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A Phase IIb dose-ranging study to assess the efficacy and safety of GIA632 in participants with non-segmental vitiligo

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Non-segmental Vitiligo (NSV)
Date of first enrollment	01/06/2026
Target sample size	20
Countries of recruitment	United states,Japan,France,Japan,Italy,Japan,Netherlands,Japan,Spain,Japan,Canada,Japan,India,Japan,Australia,Japan,Germany,Japan,China,Japan,Argentina,Japan
Study type	Interventional
Intervention(s)	- GIA632 Arm 1 : GIA632 will be administered during the 48-week core period. - GIA632 Arm 2 : GIA632 will be administered during the 48-week core period. - GIA632 Arm 3 : GIA632 will be administered during the 48-week core period. - GIA632 Arm 4 : GIA632 will be administered during the 48-week core period. - Placebo : Placebo will be administered during the 48-week core period.

Outcome(s)

Primary Outcome	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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 99age old
Gender	Both
Include 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
Exclude 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