To test different doses of a new medicine called GIA632 to see how well it works and how safe it is for people 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 nonsegmental vitiligo, followed by an extension period

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111035

Enrollment

210

Registered

2026-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: GIA632: 60 mg Every 4 weeks, 150 mg Every 4 weeks, 600 mg Every 4 weeks, 600 mg Every 2 weeks Intervention2: Placebo: 60 mg Every 4 weeks, 150 mg Every 4 weeks, 600 mg Every 4 weeks, 60

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female greater than or equal to 18 years 2. Participants with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination 3. Patients with Non segmental vitiligo evaluated at screening should have greater than or equal to 0.5 percent Body Surface Area on the face and FVASI score greater than or equal to 0.5 and greater than or equal to 3 percent Body Surface Area on non facial areas and TVASI score of 3 to 60 4. Diagnosis of non segmental vitiligo where the condition has not improved after using at least one topical treatment for 3 months which includes steroid creams, Calcineurin inhibitors, Vitamin D analogues, PDE4 inhibitors, JAK inhibitors, Aryl hydrocarbon receptor agonists

Exclusion criteria

Exclusion criteria: 1. Participants unable or unwilling to follow the study procedures or to complete the study-related questionnaires 2. Presence of skin comorbidities that may interfere with study assessments 3. Previous exposure to biologic drugs directly targeting IL15 or IL15 receptors 4. Non-responder (failure to achieve FVASI 50 after 6 months of treatment) to systemic JAKi 5. Participant who previously attempted or completed depigmentation therapy for NSV 6. Use of prohibited medication & treatments.

Design outcomes

Primary

Measure	Time frame
Percentage change in F-VASITimepoint: from baseline to week 24	—

Secondary

Measure	Time frame
Achievement of at least 75% improvement in F-VASI (F-VASI75)Timepoint: at Week 24;Percentage change in T-VASITimepoint: from baseline to Week 24;Achievement of greater than or equal to 50% improvement from baseline in T-VASI (T-VASI50)Timepoint: at Week 24;Achievement of F-VASI50, F-VASI75, and F-VASI90Timepoint: at Week 12, Week 24, Week 36, and Week 48.;Achievement of T-VASI50, T-VASI75, and T-VASI90Timepoint: at Weeks 12, Week 24, Week 36, and Week 48.;Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5Timepoint: at Week 12, Week 24, Week 36, and at Week 48.	—

Measure

Time frame

Achievement of at least 75% improvement in F-VASI (F-VASI75)Timepoint: at Week 24;Percentage change in T-VASITimepoint: from baseline to Week 24;Achievement of greater than or equal to 50% improvement from baseline in T-VASI (T-VASI50)Timepoint: at Week 24;Achievement of F-VASI50, F-VASI75, and F-VASI90Timepoint: at Week 12, Week 24, Week 36, and Week 48.;Achievement of T-VASI50, T-VASI75, and T-VASI90Timepoint: at Weeks 12, Week 24, Week 36, and Week 48.;Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5Timepoint: at Week 12, Week 24, Week 36, and at Week 48.

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Countries

Argentina, Australia, Canada, China, France, Germany, India, Italy, Japan, South Africa, Spain, United Kingdom, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026