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

Last updated: May 25, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Vitiligo

Treatment

GIA632

Placebo

Clinical Study ID

NCT07431177
CGIA632B12201
  • Ages 18-99
  • All Genders

Study 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

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 diagnosisthrough 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 tohands and feet) and T-VASI score = 3 to 60

Exclusion

Exclusion Criteria:

  • Individuals unable or unwilling to follow the study procedures and/or to completethe study-related questionnaires

  • Presence of segmental or mixed vitiligo, or other skin comorbidities that mayinterfere with study assessments (e.g., hypopigmented mycosis fungoides, geneticdiseases 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-definedinclusion/exclusion criteria may apply

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: GIA632
Phase: 2
Study Start date:
March 09, 2026
Estimated Completion Date:
January 28, 2030

Study 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 relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.

Connect with a study center

  • Novartis Investigative Site

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Waitara, New South Wales 2077
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Newmarket, Ontario L3Y 5G8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Toronto, Ontario M3H 5Y8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Québec, Quebec G1V 4X7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Shanghai, 200040
    China

    Active - Recruiting

  • Novartis Investigative Site

    Urayasu, Chiba 279-0021
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kofu, Yamanashi 400-8506
    Japan

    Active - Recruiting

  • Cahaba Derm and skin hlth ctr 27

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • MedDerm Associates

    San Diego, California 92103
    United States

    Active - Recruiting

  • Clinical Trials Research Institute

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Miami Derm and Laser Institute

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Global Clinical Professionals

    St. Petersburg, Florida 33714
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • Revival Research Institute

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Skin Specialists PC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Las Vegas Dermatology

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

  • Equity Medical

    The Bronx, New York 10455
    United States

    Active - Recruiting

  • International Clinical Research Tennessee LCC

    Murfreesboro, Tennessee 37130
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Austin Inst for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • ACRC Trials

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Virginia Clinical Research

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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