Recruiting

Phase 2

GIA632A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07431177

Conditions

Non-segmental Vitiligo

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GIA632

Placebo

Study Details

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 optimal dose to be promoted into the confirmatory Phase 3 program.

Conditions

Non-segmental Vitiligo

Study ID

NCT07431177

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Jan 28, 2030

Anticipated

Primary completion date

Jun 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GIA632 Arm 1

GIA632 will be administered during the 48-week core period.

experimental: GIA632 Arm 2

GIA632 will be administered during the 48-week core period.

experimental: GIA632 Arm 3

GIA632 will be administered during the 48-week core period.

experimental: GIA632 Arm 4

GIA632 will be administered during the 48-week core period.

placebo comparator: Placebo

Placebo will be administered during the 48-week core period.

Interventions

GIA632

GIA632 will be administered during the 48-week core period.

Placebo

Placebo will be administered during the 48-week core period.

Primary outcome measure

Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Locations

Cahaba Derm and skin hlth ctr 27

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Wes Booth

+1 205 778 1564 wbooth@cahabaderm.com

Principal Investigator:

Vlada Groysman

First OC Dermatology

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Keiry Espinoza

+1 714 531 2966 kespinoza@dermcaremgt.com

Principal Investigator:

Vivian Laquer

MedDerm Associates

Recruiting

San Diego, California, United States, 92103

Contacts

Kristian Cadag

+1 619 243 7015 kcadag@medderm.net

Principal Investigator:

Michelle Pelle

Clinical Trials Research Institute

Recruiting

Thousand Oaks, California, United States, 91320

Contacts

Shawn Ahoubim

+1 888 367 1850 clinicaltrials@calderm.net

Principal Investigator:

Navid Ezra

Encore Medical Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Yeniska Hall

+1 954 400 1725 yhall@encoremedicalresearch.com

Principal Investigator:

Jerome Obed

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Jarell C Hughes

+1 904 953 2000 hughes.jarell@mayo.edu

Principal Investigator:

Ashley Wentworth

Miami Derm and Laser Institute

Recruiting

Miami, Florida, United States, 33173

Contacts

Swanee Cepero

+1 305 279 6060 swaneec@miamidermlaser.com

Principal Investigator:

Jill Waibel

Global Clinical Professionals

Recruiting

St. Petersburg, Florida, United States, 33714

Contacts

Madelaine Perez

+1 727 520 1427 mperez@researchgcp.com

Principal Investigator:

Wanda M Boote

Dawes Fretzin Clinical Rea Group

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Michelle Riggs

+1 317 516 5030#102 mgaidzik@ecommunity.com

Principal Investigator:

Kenneth Dawes

Hamzavi Dermatology

Recruiting

Fort Gratiot, Michigan, United States, 48059

Contacts

Lee Campbell

+1 810 455 1600 lcampbell@hamzavi.com

Principal Investigator:

Iltefat Hamzavi

Revival Research Institute

Recruiting

Troy, Michigan, United States, 48084

Contacts

Madhuri Para

+1 248 564 1485 mpara@rev-research.com

Principal Investigator:

Ali Moiin

Skin Specialists PC

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Schyler Schriever

+1 402 334 7546 Schyler@LovelySkin.com

Principal Investigator:

Joel Schlessinger

Las Vegas Dermatology

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Faith Limon

+1 702 456 3120 ftrujillo@lvderm.com

Principal Investigator:

Harry Lawrence Greenberg

Equity Medical

Recruiting

The Bronx, New York, United States, 10455

Contacts

Luana Cabreja

lcabreja@equity-med.com

Principal Investigator:

Michael Cameron

Oregon Medical Research Center

Recruiting

Portland, Oregon, United States, 97223

Contacts

Megan Lamey

+1 503 245 0315 mlamey@oregonmedicalresearch.com

Principal Investigator:

Benjamin D Ehst

International Clinical Research Tennessee LCC

Recruiting

Murfreesboro, Tennessee, United States, 37130

Contacts

Miles Guy

+1 615 410 3450 mguy@icresearch.net

Principal Investigator:

Christina Feser

Bellaire Dermatology Associates

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Luis Leal Ruiz

+1 713 661 4383 luis.leal@bellairedermatology.com

Principal Investigator:

Craig F Teller

Center for Clinical Studies

Recruiting

Houston, Texas, United States, 77030

Contacts

Perla Rivas

+1 713 528 8818 privas@ccstexas.com

Principal Investigator:

Stephen K Tyring

Austin Inst for Clinical Research

Recruiting

Pflugerville, Texas, United States, 78660

Contacts

Tolga Han

+1 512 259 2545 tolga.han@atxresearch.com

Principal Investigator:

Edward Lain

ACRC Trials

Recruiting

Plano, Texas, United States, 75024

Contacts

Jani Taylor

+1 972 354 1520 JaniT@acrctrials.com

Principal Investigator:

Seemal Rohit Desai

Virginia Clinical Research

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Crystal Temple

+1 757 625 0151 ctemple@vcrinc.org

Principal Investigator:

David M Pariser

Novartis Investigative Site

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Novartis Investigative Site

Recruiting

Winnipeg, Manitoba, Canada, R3M 3Z4

Novartis Investigative Site

Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Novartis Investigative Site

Recruiting

Newmarket, Ontario, Canada, L3Y 5G8

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M3H 5Y8

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1V 4X7

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

Phase 2b
interventional
vitiligo
efficacy
safety
dose ranging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-09.