A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-segmental Vitiligo

In brief

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.

Key facts

Study ID

NCT07431177

Run by

Novartis Pharmaceuticals

People needed

210

Starts

2026-03-09

Expected to finish

2030-01-28

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• First OC Dermatology — Fountain Valley, California, United States (enrolling)
• MedDerm Associates — San Diego, California, United States (enrolling)
• Clinical Trials Research Institute — Thousand Oaks, California, United States (enrolling)
• Encore Medical Research — Hollywood, Florida, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Miami Derm and Laser Institute — Miami, Florida, United States (enrolling)
• Global Clinical Professionals — St. Petersburg, Florida, United States (enrolling)
• Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana, United States (enrolling)
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States (enrolling)
• Revival Research Institute — Troy, Michigan, United States (enrolling)
• Skin Specialists PC — Omaha, Nebraska, United States (enrolling)
• Las Vegas Dermatology — Las Vegas, Nevada, United States (enrolling)
• Equity Medical — The Bronx, New York, United States (enrolling)
• Oregon Medical Research Center — Portland, Oregon, United States (enrolling)
• International Clinical Research Tennessee LCC — Murfreesboro, Tennessee, United States (enrolling)
• Bellaire Dermatology Associates — Bellaire, Texas, United States (enrolling)
• Center for Clinical Studies — Houston, Texas, United States (enrolling)
• Austin Inst for Clinical Research — Pflugerville, Texas, United States (enrolling)
• ACRC Trials — Plano, Texas, United States (enrolling)
• Virginia Clinical Research — Norfolk, Virginia, United States (enrolling)
• Novartis Investigative Site — Sydney, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Waitara, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Melbourne, Victoria, Australia (enrolling)
• Novartis Investigative Site — Calgary, Alberta, Canada (enrolling)
• Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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