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Phase IIb Randomized, Double‑Blind Study of GIA632 in Adults with Nonsegmental Vitiligo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Non‑segmental vitiligo is a skin condition in which the immune system gradually removes pigment from large areas of the skin, often affecting the face and visible parts of the body. The study is testing a new medication called GIA632, which is given as a small injection under the skin, and comparing it with a harmless substance known as placebo to see if it can help restore color to the affected areas.

The main goal of the trial is to find the dose of GIA632 that works best for increasing skin color in people with this type of vitiligo. Participants will receive a series of injections over several months, with regular check‑ins to monitor any changes in the appearance of the skin and to watch for possible side effects. The study also uses a simple scoring system called the facial Vitiligo Area Scoring Index to measure how much the facial skin has repigmented, helping researchers understand whether the treatment is effective and safe.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and randomization

    You attend the first clinic appointment after joining the study. during this visit baseline measurements of your skin condition are recorded and blood samples may be taken.

    You are randomly assigned to receive either gia632 or placebo. the assignment is unknown to you and the study staff.

  2. Step 2

    Administration of study medication

    You receive a subcutaneous injection of the assigned product. the injection contains a solution for injection with a dose recorded as "00" in the study documentation.

    The injection is given according to the study schedule and continues for the duration of the main trial period, which extends to week 48.

  3. Step 3

    Regular follow‑up visits

    You attend clinic visits at week 12, week 24, week 36 and week 48. at each visit the study team evaluates the facial and total vitiligo area scoring index (f‑vasi and t‑vasi) to assess changes in skin pigmentation.

    The visits also include safety checks for any treatment‑emergent adverse events or serious adverse events.

  4. Step 4

    Assessment of efficacy endpoints

    At week 24 the primary outcome is measured: the percentage change from baseline in the f‑vasi score.

    Secondary outcomes such as achieving at least 75 % improvement in f‑vasi (f‑vasi75), 50 % improvement in t‑vasi (t‑vasi50), and other skin‑re‑pigmentation targets are also recorded at weeks 12, 24, 36 and 48.

  5. Step 5

    Extension period (optional)

    After week 48 an optional extension period may be offered. if you choose to continue, additional injections and assessments are performed according to the extension protocol.

Who can join the trial?

4 criteria

  • Provide written permission (called informed consent) after the study is explained to you.
  • Be 18 years of age or older at the time of screening, no matter whether you were assigned male or female at birth.
  • Have a doctor confirm that you have non‑segmental vitiligo, a form of vitiligo that causes many depigmented patches across different parts of the skin.
  • Show that the vitiligo affects at least 0.5% of the skin on your face and have a facial score (the F‑VASI score) of 0.5 or higher, or that it covers at least 3% of the skin on other parts of your body (including hands and feet) and have a total body score (the T‑VASI score) between 3 and 60. Body Surface Area (BSA) refers to the percentage of your skin that is affected.

Who cannot join the trial?

5 criteria

  • Unable or unwilling to follow the study steps and to complete the study questionnaires.
  • Having segmental or mixed vitiligo (a form that affects only one side or a limited area) or other skin problems that could affect the study results, such as hypopigmented mycosis fungoides (a type of skin lymphoma that causes lighter patches), genetic pigment disorders like piebaldism or Waardenburg syndrome (conditions that cause patches of missing pigment), or skin lightening caused by chemicals or medicines (chemical‑ or drug‑induced leukoderma).
  • Previous use of biologic medicines that directly target IL‑15 or its receptors (IL‑15 is a protein that helps control the immune system).
  • Having tried or completed a skin‑lightening treatment called depigmentation therapy for vitiligo (a procedure that intentionally removes remaining pigment from the skin).
  • Using any medication or treatment that the study lists as not allowed (prohibited medication & treatments).
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Investigated drugs

GIA632
GIA632 is an experimental medicine being tested for people with non‑segmental vitiligo, a condition that causes loss of skin color in patches. In this study, participants receive GIA632 by a small injection under the skin. The goal is to see if the medicine can help the skin regain its normal color, especially on the face, by comparing changes in a skin‑pigment score after several weeks of treatment. The trial examines different amounts of the medicine to find the best dose that works safely and effectively.

What is already known about the treatment

GIA632 - GIA632 is provided as a clear solution for injection that is given under the skin (subcutaneous injection). It is still experimental and is currently being evaluated in a Phase IIb clinical trial, so it has not yet received routine approval for medical use. The medication is being tested to treat non‑segmental vitiligo, a skin condition that causes loss of pigment. It works by attaching to a specific immune‑system protein, which calms the immune attack on pigment‑producing cells, and it is classified as a biologic immunomodulator.

Investigated diseases

Nonsegmental vitiligo - Nonsegmental vitiligo is a chronic skin condition characterized by loss of pigment in patches that are not limited to a single dermatome. It typically begins with small lighter spots that gradually enlarge and can spread to other areas of the body over time. The distribution of depigmented patches may be symmetric and can affect the face, hands, and other exposed skin. The condition progresses at varying rates, with some individuals experiencing slow changes while others notice more rapid spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522301-37-00Protocol codeCGIA632B12201Estimated enrolment210 patientsSponsorNovartis Pharma AG

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