Last Update: May 27, 2026
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adult Participants With Non-segmental Vitiligo Followed by an Extension Period
ClinicalTrials.gov Identifier:
Novartis Reference Number:CGIA632B12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Non-segmental Vitiligo
Phase2
Recruiting
210
Mar 09, 2026
Jan 28, 2030
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug

GIA632

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

Placebo

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

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

Novartis Investigative Site

Recruiting

Sydney,New South Wales,2010,Australia

Novartis Investigative Site

Recruiting

Waitara,New South Wales,2077,Australia

Novartis Investigative Site

Recruiting

Melbourne,Victoria,3000,Australia

Novartis Investigative Site

Recruiting

Mississauga,Ontario,L4y 4c5,Canada

Novartis Investigative Site

Recruiting

Québec,Quebec,G1v 4x7,Canada

Novartis Investigative Site

Recruiting

Newmarket,Ontario,L3y 5g8,Canada

Novartis Investigative Site

Recruiting

Toronto,Ontario,M3h 5y8,Canada

Novartis Investigative Site

Recruiting

Shanghai,200040,China

Novartis Investigative Site

Recruiting

Kofu,Yamanashi,400-8506,Japan

Novartis Investigative Site

Recruiting

Urayasu,Chiba,279-0021,Japan

ACRC Trials

Recruiting

Plano,Texas,75024,United States

Seemal Rohit Desai
Jani Taylor

Las Vegas Dermatology

Recruiting

Las Vegas,Nevada,89144,United States

Harry Lawrence Greenberg
Faith Limon

International Clinical Research Tennessee LCC

Recruiting

Murfreesboro,Tennessee,37130,United States

Miles Guy
Christina Feser

Virginia Clinical Research

Recruiting

Norfolk,Virginia,23507,United States

David M Pariser
Crystal Temple

Global Clinical Professionals

Recruiting

St. Petersburg,Florida,33714,United States

Wanda M Boote
Madelaine Perez

MedDerm Associates

Recruiting

San Diego,California,92103,United States

Kristian Cadag
Michelle Pelle

Center for Clinical Studies

Recruiting

Houston,Texas,77030,United States

Stephen K Tyring
Perla Rivas

Dawes Fretzin Clinical Rea Group

Recruiting

Indianapolis,Indiana,46256,United States

Kenneth Dawes
Michelle Riggs

Revival Research Institute

Recruiting

Troy,Michigan,48084,United States

Madhuri Para
Ali Moiin

Cahaba Derm and skin hlth ctr 27

Recruiting

Birmingham,Alabama,35244,United States

Vlada Groysman
Wes Booth

Miami Derm and Laser Institute

Recruiting

Miami,Florida,33173,United States

Jill Waibel
Swanee Cepero

Austin Inst for Clinical Research

Recruiting

Pflugerville,Texas,78660,United States

Edward Lain
Tolga Han

Clinical Trials Research Institute

Recruiting

Thousand Oaks,California,91320,United States

Navid Ezra
Shawn Ahoubim

Equity Medical

Recruiting

The Bronx,New York,10455,United States

Michael Cameron
Luana Cabreja

Hamzavi Dermatology

Recruiting

Fort Gratiot,Michigan,48059,United States

Iltefat Hamzavi
Lee Campbell

Skin Specialists PC

Recruiting

Omaha,Nebraska,68144,United States

Joel Schlessinger
Schyler Schriever

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals