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NCT07431177
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Conditions: Non-segmental Vitiligo
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 210
Sponsor: Novartis Pharmaceuticals
Location: Cahaba Derm and skin hlth ctr 27 Birmingham Alabama
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 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
Source: ClinicalTrials.gov (NCT07431177). StuddyBuddy aggregates publicly available trial information.