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

RecruitingPhase 2

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

Who can join

Ages 18 to 99 · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 210 · Started: Mar 9, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07431177

Locations in the U.S.

AlabamaCahaba Derm and skin hlth ctr 27, Birmingham
CaliforniaFirst OC Dermatology, Fountain Valley
MedDerm Associates, San Diego
Clinical Trials Research Institute, Thousand Oaks
FloridaEncore Medical Research, Hollywood
Mayo Clinic Jacksonville, Jacksonville
Miami Derm and Laser Institute, Miami
Global Clinical Professionals, St. Petersburg
IndianaDawes Fretzin Clinical Rea Group, Indianapolis
MichiganHamzavi Dermatology, Fort Gratiot
Revival Research Institute, Troy
NebraskaSkin Specialists PC, Omaha
NevadaLas Vegas Dermatology, Las Vegas
New YorkEquity Medical, The Bronx
OregonOregon Medical Research Center, Portland
TennesseeInternational Clinical Research Tennessee LCC, Murfreesboro
TexasBellaire Dermatology Associates, Bellaire
Center for Clinical Studies, Houston
Austin Inst for Clinical Research, Pflugerville
ACRC Trials, Plano
VirginiaVirginia Clinical Research, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.