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A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
210 patients around the world
Available in Argentina, United States
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.
Novartis Pharmaceuticals
210Patients around the world
This study is for people with
Vitiligo
Nonsegmental Vitiligo
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- 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.
- 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.
StudyVITESS
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Nonsegmental Vitiligo
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07431177
