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

RECRUITINGPHASE2

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

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

NCT07431177•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (6)

Cahaba Derm and skin hlth ctr 27

Birmingham, Alabama, United States

Miami Derm and Laser Institute

Miami, Florida, United States

Revival Research Institute

Troy, Michigan, United States

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Waitara, New South Wales, Australia

Novartis Investigative Site

Toronto, Ontario, Canada

Key Dates

Start Date

March 9, 2026

Primary Completion Date

June 23, 2028

Completion Date

February 14, 2030

Last Updated

March 19, 2026

Enrollment

210

ESTIMATED participants

Conditions

Non-segmental Vitiligo

Interventions

GIA632

DRUG

Placebo

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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