A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Key facts
- Where
- Kofu, Nagoya, Niigata, Shinjuku Ku, and Urayasu, JapanSee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07431177, who can take part
Where in Japan
- Kofu, YamanashiHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Nagoya, Aichi-kenHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- NiigataHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Shinjuku Ku, TokyoHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Urayasu, ChibaHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07431177EU 2025-522301-37-00
- Record updated
- 9 November 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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.); Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires.