A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Ancona, Ferrara, Milan, and Rozzano, ItalySee the 4 sitesAlso in 11 other countries, 81 sites
- Trial code
- NCT07431177
- EU 2025-522301-37-00
- U1111-1324-4562
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 210 people, planned
- Started
- 9 Mar 2026
- Expected to end
- 28 Jan 2030
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- GIA632
- Placebo
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 11 other countries, 81 sites
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- GIA632 Arm 1Treatment being tested
GIA632 will be administered during the 48-week core period.
Treatment: GIA632
- GIA632 Arm 2Treatment being tested
GIA632 will be administered during the 48-week core period.
Treatment: GIA632
- GIA632 Arm 3Treatment being tested
GIA632 will be administered during the 48-week core period.
Treatment: GIA632
- GIA632 Arm 4Treatment being tested
GIA632 will be administered during the 48-week core period.
Treatment: GIA632
- PlaceboPlacebo, for comparison
Placebo will be administered during the 48-week core period.
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Fit questions
- Built from NCT07431177, who can take part
- Record updated
- 9 November 2026