Status:
RECRUITING
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 optim...
Detailed Description
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 relation...
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
Key Trial Info
Start Date :
March 9 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2030
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT07431177
Start Date
March 9 2026
End Date
February 14 2030
Last Update
April 6 2026
Active Locations (10)
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1
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States, 35244
2
Clinical Trials Research Institute
Thousand Oaks, California, United States, 91320
3
Miami Derm and Laser Institute
Miami, Florida, United States, 33173
4
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States, 46256