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 research is looking into a new treatment called GIA632 for adults who have non-segmental vitiligo. This type of vitiligo causes patches of skin to lose their colour. The study will compare GIA632 to a 'dummy' treatment (placebo) to see how effective and safe it is. Researchers want to find out how much the skin repigments, meaning how much colour returns to the white patches. They'll also be carefully checking for any side effects. This is a Phase II study, which means it's one of the earlier steps in developing a new medicine, focusing on finding the right dose and confirming its effects.
Em resumo
Sobre o que é este estudo?
This study is about a skin condition called non-segmental vitiligo. This is when patches of your skin lose their natural colour, often in many places on your body. Researchers are exploring a new medicine called GIA632 that they hope might help bring colour back to these patches.
The main goal of the study is to measure how much the vitiligo patches improve over 24 weeks – that's about six months. They will use special tools to measure changes in the amount of colour in the skin. They will also keep a close eye on any side effects or unwanted reactions to the medicine, to make sure it's safe.
The study also looks at other things, like how many people see a significant improvement, such as 50%, 75%, or even 90% of their skin colour returning. These measurements will be taken at different times over a longer period, up to 48 weeks (about 11 months), to see if the improvements last. By doing this, the researchers hope to understand if GIA632 could be a good new way to treat vitiligo.
Pontos principais
- This study tests a new medicine (GIA632) for vitiligo.
- It aims to see if the medicine helps bring colour back to skin patches.
- The study also carefully checks for side effects and safety.
- Some participants will receive a dummy medicine.
- The study lasts for up to 48 weeks.
- It's for adults aged 18 and over with non-segmental vitiligo.
Quem pode ser elegível?
To join this study, you must be an adult, aged 18 years or older. Both men and women are welcome to take part.
Only people who have been diagnosed with non-segmental vitiligo can participate. This specific type of vitiligo affects various parts of the body, rather than just one area or side.
There may be other reasons why you can or cannot join the study, but these would be discussed in detail by the study team. They will ensure the study is right for you and that you meet all necessary health requirements.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Do you have non-segmental vitiligo?
- Você consegue comparecer a consultas regulares na clínica?
- Are you willing to potentially receive a dummy medicine?
- Are you keen to help research new treatments?
O que envolve a participação?
If you decide to take part, you would be assigned to either receive the new medicine (GIA632) or a dummy medicine (placebo). Neither you nor the study doctors will know which one you are receiving during the main part of the study. You will have regular visits to the clinic where doctors and nurses will check your skin, measure any changes in your vitiligo, and ask about your general health. These assessments will involve measuring the colour of your skin patches, taking photographs, and checking for any side effects. These visits will be spread out over a period of up to 48 weeks (about 11 months) in total. There will also be a follow-up period after you stop taking the study medicine.
Riscos e benefícios potenciais
Localizações (4)
- —Não verificadoAlemanha
- —Não verificadoPaíses Baixos
- —Não verificadoFrança
- —Não verificadoItália
Perguntas frequentes
O que é vitiligo?
Vitiligo is a long-term skin condition where patches of skin lose their pigment, causing white areas to appear on your body.
What does 'non-segmental' vitiligo mean?
This means your vitiligo patches can appear on various parts of your body, rather than just one specific area or side.
What is a 'dummy medicine' or 'placebo'?
A placebo looks exactly like the study medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the actual medicine or the placebo?
No, during the main part of the study, neither you nor the study doctors will know. This is called 'double-blind' and helps ensure fair results.
Quanto tempo durará o estudo se eu participar?
The main part of the study will last around 24 weeks (6 months), with further checks extending up to about 48 weeks (11 months) in total.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.