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A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

RecruitingPhase 2Ages 18 Years - 99 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * Male or female as assigned at birth โ‰ฅ 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 * โ‰ฅ 0.5% Body Surface Area (BSA) on the face and F-VASI score โ‰ฅ 0.5 * โ‰ฅ 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
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What it tests

  • GIA632
  • Placebo
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Where

83 sites
Cahaba Derm and skin hlth ctr 27
Birmingham, United States
First OC Dermatology
Fountain Valley, United States
MedDerm Associates
San Diego, United States
Clinical Trials Research Institute
Thousand Oaks, United States
Encore Medical Research
Hollywood, United States
Mayo Clinic Jacksonville
Jacksonville, United States
Miami Derm and Laser Institute
Miami, United States
Global Clinical Professionals
St. Petersburg, United States

โ€ฆand 75 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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