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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07431177). StuddyBuddy aggregates publicly available trial information.