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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Page 1 of 3 (10 locations)

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