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A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with nonsegmental vitiligo, followed by an extension period (CGIA632B12201)

A Phase IIb dose-ranging study to assess the efficacy and safety of GIA632 in participants with non-segmental vitiligo (CGIA632B12201)

Shimizu Kenichi

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Shimizu Kenichi

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Recruiting

June. 01, 2026

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

- 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

- 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

Both

Non-segmental Vitiligo (NSV)

- GIA632 Arm 1 : GIA632 will be administered during the 48-week core period.
- GIA632 Arm 2 : GIA632 will be administered during the 48-week core period.
- GIA632 Arm 3 : GIA632 will be administered during the 48-week core period.
- GIA632 Arm 4 : GIA632 will be administered during the 48-week core period.
- Placebo : Placebo will be administered during the 48-week core period.

The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.

Mar. 24, 2026

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

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