KAN-101-03: A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
This study, called KAN-101-03, is looking into a new medicine called KAN-101 for people who have coeliac disease. It's a Phase 2a trial, which means it's an early stage study designed to understand if the medicine works to improve the gut lining, how safe it is, and how well people can tolerate it. Some participants will receive KAN-101, while others will get a placebo (a dummy treatment, like salt water) without knowing which they have. Researchers will take measurements, including small samples of the gut lining, to see if the medicine helps the gut heal and reduce inflammation. The study also checks for any side effects and how the body handles the medicine. It's for adults aged 18 and over, of any sex.
Em resumo
Sobre o que é este estudo?
This research study is about a new medicine called KAN-101 for people living with coeliac disease. Coeliac disease is a condition where eating gluten, found in foods like wheat, barley, and rye, damages the lining of your small intestine. This damage can make it hard for your body to absorb nutrients and can cause symptoms like tummy pain, bloating, and tiredness.
The main goal of this study is to see if KAN-101 can help to heal the damage in the small intestine caused by coeliac disease. Researchers are particularly interested in looking at how the small intestine's villi – the tiny, finger-like structures that absorb nutrients – respond to the treatment. They also want to understand if the medicine is safe to use and if people can take it without too many problems.
To do this, some participants will receive the active medicine (KAN-101) and others will receive a placebo, which looks exactly like the medicine but contains no active ingredients. This is a common way to test new medicines fairly. By comparing the results from both groups, the researchers can work out if KAN-101 is genuinely effective and safe. The study also looks at other changes in the gut and monitors for any side effects.
Pontos principais
- This study is testing a new medicine (KAN-101) for coeliac disease.
- It aims to see if the medicine helps heal the gut and if it's safe.
- You might receive the new medicine or a dummy treatment (placebo).
- It involves regular clinic visits, blood tests, and an endoscopy with biopsies.
- The study is for adults aged 18 and over, regardless of sex.
Quem pode ser elegível?
To take part in this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate if they meet other health requirements.
Both men and women are welcome to join this study. The researchers want to include a wide range of people to understand how the medicine works across different individuals.
Specific medical details will be checked by the study team to make sure it's safe for you to take part and that the study results will be meaningful. For example, they'll need to confirm you have coeliac disease and may ask about other health conditions or medicines you are currently taking.
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?
- Have you been diagnosed with coeliac disease?
- Você consegue comparecer às consultas na clínica de estudos?
- Are you comfortable with having an endoscopy with biopsies?
- Are you willing to potentially receive a placebo?
- Do you understand that you will need to continue your gluten-free diet during the study?
O que envolve a participação?
If you decide to take part, you will be in the study for a certain period. During this time, you will receive either the new medicine, KAN-101, or a placebo (a dummy treatment made of salt water). This will be given as a drip into your arm (intravenous infusion). You won't know whether you are receiving the real medicine or the placebo.
You'll have several visits to the clinic. These visits will involve various checks and assessments, such as blood tests, physical examinations, and possibly questionnaires about how you are feeling. A key part of the study involves an endoscopy, which is a procedure where a thin, flexible tube with a camera is passed down your throat to look at your small intestine. During this, small tissue samples (biopsies) will be taken. This happens at the beginning of the study and again after two weeks of receiving the treatment to see if there have been any changes in your gut lining. The total duration of your active participation, including follow-up, will be explained fully by the study team.
Riscos e benefícios potenciais
Localizações (5)
- —Não verificadoFinlândia
- —Não verificadoIrlanda
- —Não verificadoPolônia
- —Não verificadoAlemanha
- —Não verificadoPaíses Baixos
Perguntas frequentes
What is KAN-101?
KAN-101 is a new medicine being tested to see if it can help heal the gut lining in people with coeliac disease.
O que é um placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used for comparison.
Will I know if I'm getting the medicine or the placebo?
Não, este é um estudo 'duplo-cego', o que significa que nem você nem o médico do estudo saberão qual tratamento você está recebendo até que o estudo termine.
What is an endoscopy and why is it needed?
An endoscopy is a procedure to look inside your small intestine and take tiny tissue samples (biopsies). It's needed to check for changes in your gut lining caused by coeliac disease and to see if the medicine is helping it heal.
Posso parar de participar do estudo se eu quiser?
Yes, you can choose to leave the study at any point, for any reason, and it won't affect your ongoing medical care.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.