Different doses of GIA632 for adults with non-segmental vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cahaba Derm and skin hlth ctr 27
  Birmingham, Alabama, United States Recruiting
• First OC Dermatology
  Fountain Valley, California, United States Recruiting
• MedDerm Associates
  San Diego, California, United States Recruiting
• Clinical Trials Research Institute
  Thousand Oaks, California, United States Recruiting
• Encore Medical Research
  Hollywood, Florida, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ICP-332 treatment for non-segmental vitiligo

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.