Different doses of GIA632 for adults 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 Non-segmental Vitiligo Followed by an Extension Period

This trial tests whether different doses of GIA632 can safely help restore skin pigment in adults with non-segmental vitiligo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (industry)
• Locations: 20 sites (Birmingham, Alabama and 19 other locations)
• Trial ID: NCT07431177 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2b dose-ranging trial that aims to characterize the dose-response of GIA632 in adults with non-segmental vitiligo. Participants are randomized to receive varying doses of GIA632 or placebo during a controlled period to estimate treatment effects versus placebo. The trial then continues into an extension period to assess longer-term safety and efficacy of the selected doses. Study entry requires physician-confirmed non-segmental vitiligo and minimum face and non-face body surface area involvement as measured by VASI scores.

Who should consider this trial

Good fit: Adults aged 18 or older with physician-confirmed non-segmental vitiligo who meet the trial's minimum face and non-face body surface area and VASI score criteria are ideal candidates.

Not a fit: People with segmental or mixed vitiligo, other pigmentary disorders, or who are unable or unwilling to attend study visits and complete procedures are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, GIA632 could help restore pigment in affected skin and identify an effective dose for a larger Phase 3 program.

How similar studies have performed: Other targeted and systemic therapies for vitiligo have shown promise in prior trials, but GIA632's specific clinical benefits and optimal dose are still unproven.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Birmingham, Alabama and 19 other locations

• Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama, United States (RECRUITING)
• Clinical Trials Research Institute — Thousand Oaks, California, United States (RECRUITING)
• Miami Derm and Laser Institute — Miami, Florida, United States (RECRUITING)
• Global Clinical Professionals — St. Petersburg, Florida, United States (RECRUITING)
• Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana, United States (RECRUITING)
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States (RECRUITING)
• Revival Research Institute — Troy, Michigan, United States (RECRUITING)
• Skin Specialists PC — Omaha, Nebraska, United States (RECRUITING)
• Las Vegas Dermatology — Las Vegas, Nevada, United States (RECRUITING)
• Equity Medical — The Bronx, New York, United States (RECRUITING)
• Center for Clinical Studies — Houston, Texas, United States (RECRUITING)
• Austin Inst for Clinical Research — Pflugerville, Texas, United States (RECRUITING)
• Virginia Clinical Research — Norfolk, Virginia, United States (RECRUITING)
• Novartis Investigative Site — Sydney, New South Wales, Australia (RECRUITING)
• Novartis Investigative Site — Waitara, New South Wales, Australia (RECRUITING)
• Novartis Investigative Site — Melbourne, Victoria, Australia (RECRUITING)
• Novartis Investigative Site — Mississauga, Ontario, Canada (RECRUITING)
• Novartis Investigative Site — Newmarket, Ontario, Canada (RECRUITING)
• Novartis Investigative Site — Toronto, Ontario, Canada (RECRUITING)
• Novartis Investigative Site — Québec, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Non-segmental Vitiligo, Phase 2b, interventional, vitiligo, efficacy, safety, dose ranging