Last Update: Mar 13, 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
Mar 08, 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

Revival Research Institute

Recruiting

Troy,Michigan,48084,United States

Ali Moiin
Madhuri Para

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals