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NCT07431177PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

3/9/2026

Completion Date

1/28/2030

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.

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 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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DRUG

GIA632

DRUG

Placebo

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Conditions

Non-segmental Vitiligo

Locations

Cahaba Derm and skin hlth ctr 27

Birmingham, Alabama 35244

United States

First OC Dermatology

Fountain Valley, California 92708

United States

MedDerm Associates

San Diego, California 92103

United States

Clinical Trials Research Institute

Thousand Oaks, California 91320

United States

Encore Medical Research

Hollywood, Florida 33024

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Miami Derm and Laser Institute

Miami, Florida 33173

United States

Global Clinical Professionals

St. Petersburg, Florida 33714

United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana 46256

United States

Hamzavi Dermatology

Fort Gratiot, Michigan 48059

United States

Revival Research Institute

Troy, Michigan 48084

United States

Skin Specialists PC

Omaha, Nebraska 68144

United States

Las Vegas Dermatology

Las Vegas, Nevada 89144

United States

Equity Medical

The Bronx, New York 10455

United States

Oregon Medical Research Center

Portland, Oregon 97223

United States

International Clinical Research Tennessee LCC

Murfreesboro, Tennessee 37130

United States

Bellaire Dermatology Associates

Bellaire, Texas 77401

United States

Center for Clinical Studies

Houston, Texas 77030

United States

Austin Inst for Clinical Research

Pflugerville, Texas 78660

United States

ACRC Trials

Plano, Texas 75024

United States

Virginia Clinical Research

Norfolk, Virginia 23507

United States

Novartis Investigative Site

Sydney, New South Wales 2010

Australia

Novartis Investigative Site

Waitara, New South Wales 2077

Australia

Novartis Investigative Site

Melbourne, Victoria 3000

Australia

Novartis Investigative Site

Calgary, Alberta T2J 7E1

Canada

Novartis Investigative Site

Winnipeg, Manitoba R3M 3Z4

Canada

Novartis Investigative Site

Mississauga, Ontario L4Y 4C5

Canada

Novartis Investigative Site

Newmarket, Ontario L3Y 5G8

Canada

Novartis Investigative Site

Toronto, Ontario M3H 5Y8

Canada

Novartis Investigative Site

Québec, Quebec G1V 4X7

Canada

Novartis Investigative Site

Beijing, 100050

China

Novartis Investigative Site

Shanghai, 200040

China

Novartis Investigative Site

Brest, 29609

France

Novartis Investigative Site

Rouen, 76031

France

Novartis Investigative Site

Toulouse, 31400

France

Novartis Investigative Site

Munich, Bavaria 81377

Germany

Novartis Investigative Site

Bad Bentheim, 48455

Germany

Novartis Investigative Site

Hamburg, 20354

Germany

Novartis Investigative Site

Münster, 48149

Germany

Novartis Investigative Site

Ahmedabad, Gujarat 380016

India

Novartis Investigative Site

Bangalore, Karnataka 560074

India

Novartis Investigative Site

Belagavi, Karnataka 590010

India

Novartis Investigative Site

Mysore, Karnataka 570001

India

Novartis Investigative Site

Nashik, Maharashtra 422101

India

Novartis Investigative Site

Ancona, AN 60020

Italy

Novartis Investigative Site

Rozzano, MI 20089

Italy

Novartis Investigative Site

Urayasu, Chiba 279-0021

Japan

Novartis Investigative Site

Kofu, Yamanashi 400-8506

Japan

Novartis Investigative Site

Niigata, 9518520

Japan

Novartis Investigative Site

Amsterdam, North Holland 1105 AZ

Netherlands

Novartis Investigative Site

Rotterdam, South Holland 3015 GD

Netherlands

Novartis Investigative Site

Barcelona, 08041

Spain