Phase IIb Randomized Study of GIA632 vs Placebo to Assess Efficacy and Safety in Adults with Nonsegmental Vitiligo

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What is this study about?

Non‑segmental vitiligo is the most common form of vitiligo, a condition in which the skin loses its normal color in patches that can appear on many parts of the body. The study is testing a new medicine called GIA632, which is given as a small injection under the skin (subcutaneous injection). The aim of the trial is to find out how different amounts of the medicine work and whether they are safe for adults with this type of vitiligo.

Participants will be randomly assigned to receive either the medicine or a harmless substance called placebo and will receive injections at scheduled visits over several weeks. During the study, doctors will look at the change in skin color on the face using a score called the F-VASI, which measures how much of the facial area is repigmented, and they will also check for any side effects. After the initial 24‑week period, participants may continue in an extension phase to see longer‑term results.

1 randomization

after joining, you are assigned to receive either giai632 or a placebo. assignment is done by computer and you do not know which you receive.

the assignment determines which injection you will receive during the trial.

2 baseline assessment

at the first visit, measurements of skin areas affected by vitiligo are recorded.

the facial vitiligo area scoring index (f‑vasi) and total vitiligo area scoring index (t‑vasi) are calculated to track changes over time.

photographs and questionnaires are taken to establish a starting point.

3 initial injection

you receive a subcutaneous injection (under the skin) of the assigned product.

the product is a solution for injection; for giai632 the dose is listed as 00 df dosage form.

injections are given according to the study schedule and continue for the duration of the trial.

4 ongoing injections

you continue to receive the same type of injection at regular intervals defined by the protocol.

the injections are administered until week 48, unless the study ends earlier for safety reasons.

each injection follows the same dose and route as the initial injection.

5 follow‑up visits

at weeks 12, 24, 36 and 48 you attend clinic visits for safety checks and efficacy assessments.

the same skin scoring indexes (f‑vasi and t‑vasi) are measured to determine the percentage change from baseline.

adverse events are recorded at each visit.

6 extension period

after week 48 an optional extension period may begin, allowing continued treatment and observation.

the same injection schedule and assessments are used during the extension.

Who Can Join the Study?

  • Provide a signed informed consent (a written agreement that you understand the study and agree to join).
  • Be at least 18 years old at the time of screening, regardless of being male or female as assigned at birth.
  • Have a doctor‑confirmed diagnosis of non‑segmental vitiligo (a type of skin‑color loss that is spread over many areas, not just one segment).
  • At screening, meet one of the following skin‑involvement requirements:
    • At least 0.5% Body Surface Area (BSA) on the face (the percentage of your total skin that is affected) and a F‑VASI score of 0.5 or higher (a number that measures how much facial vitiligo you have).
    • At least 3% Body Surface Area (BSA) on non‑facial areas (including hands and feet) and a T‑VASI score between 3 and 60 (a number that measures total body vitiligo).

Who Cannot Join the Study?

  • Cannot or does not want to follow the study steps or fill out the study questionnaires.
  • Has segmental vitiligo (vitiligo that affects only one area), mixed vitiligo (a combination of segmental and non‑segmental types), or other skin problems that could affect the study results, such as hypopigmented mycosis fungoides (a type of skin lymphoma that causes light patches), genetic conditions that change skin color like piebaldism or Waardenburg syndrome, or skin lightening caused by chemicals or drugs (leukoderma).
  • Has taken special medicines called biologic drugs that directly target a protein named IL-15 or its receptors. (IL-15 is a part of the immune system that can affect skin color changes.)
  • Previously tried or finished a treatment that intentionally removes skin color, known as depigmentation therapy, for non‑segmental vitiligo.
  • Is currently using any medication or treatment that the study has listed as not allowed (prohibited medication and treatments).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Dermatologikum Hamburg GmbH Hamburg Germany
Klinikum Bielefeld gGmbH Bielefeld Germany
Courlancy Sante Reims France
Afafnmpqj Uux Amsterdam The Netherlands
Efgwofk Ulvsxaqnigrc Mzdsmrx Ceisyeb Rlkjltpbt (qxopjdh Mup Rotterdam The Netherlands
Uxvhauhhkcelylkhuyqzc Mjoisolf Adw Munster Germany
Gqnzky Uaoypgmbmv Fqobojjgk Frankfurt Germany
Kewywbnj diy Umiqqmsxcwjz Mwpfqarr Apk Munich Germany
Hskamohe Da Lx Styws Cpja I Sbdv Pbk Barcelona Spain
Hdqsejho Uhfjisvgmpdwn Dd Lv Pxhevunf Madrid Spain
Tszzfksstnn upo Sbmwejseyrt Bmkptlhm Gccf Bad Bentheim Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.07.2026
Germany Germany
Not yet recruiting
01.07.2026
Italy Italy
Not yet recruiting
01.07.2026
Spain Spain
Not yet recruiting
01.07.2026
The Netherlands The Netherlands
Not yet recruiting
01.07.2026

Trial locations

GIA632 is an experimental medicine being studied as a possible treatment for non‑segmental vitiligo, a condition that causes loss of skin pigment. In this trial participants receive the drug as a small injection under the skin. The medication is given as a clear liquid that is meant to help the skin regain its natural color by encouraging the return of pigment cells. Researchers are testing different amounts of the drug to see which dose works best and is safe, and they will compare the results to a placebo group. The study aims to find out if GIA632 can improve facial skin repigmentation over a 24‑week period.

Non‑segmental vitiligo – A chronic skin condition characterized by the loss of pigment-producing cells, leading to white patches that can appear on any part of the body. The patches often start small and may gradually enlarge or merge over time. The distribution of the depigmented areas is usually symmetrical, affecting both sides of the body. The condition may progress slowly, with new spots developing months or years after the first signs. Factors such as stress or skin injury can sometimes trigger the appearance of additional patches. The extent and speed of spread vary widely among individuals.

Trial ID:
2025-522301-37-00
Protocol code:
CGIA632B12201
Trial Phase:
Therapeutic exploratory (Phase II)

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