Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
This research study is investigating a new medicine, mirikizumab, for adults aged 18 to 75 who have Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive system. The study wants to see if mirikizumab can help heal the deeper layers of the bowel wall, not just the surface lining. This is called 'transmural healing'. Researchers will use special scans like MRI to check for this healing. The goal is to understand if this treatment, given either through a drip or as an injection under the skin, can improve the condition more effectively for people with active Crohn's symptoms. This is a Phase 4 study, meaning the medicine has already been approved but researchers are still gathering more information about its effects.
De un vistazo
¿De qué trata este estudio?
Crohn's disease is a condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain and needing to go to the toilet a lot. Medicines for Crohn's disease often aim to reduce these symptoms and heal the surface lining of your bowel. However, inflammation can sometimes go deeper into the bowel wall. This study is looking at a new medicine called mirikizumab, and specifically whether it can help heal these deeper layers of the bowel, which is known as 'transmural healing'.
Recognising and treating this deeper healing is important because it might lead to better long-term health for people with Crohn's. The study will use special scans, like MRI, to see if mirikizumab helps to reduce this deeper inflammation and encourages healing within the bowel wall. Doctors want to understand if this approach could make a real difference to how well people with Crohn's disease manage their condition.
Mirikizumab is already an approved medicine, but this particular study is a 'Phase 4' trial. This means that while the medicine is available, researchers are still gathering more detailed information about its effects, especially concerning this specific type of healing in Crohn's disease. Understanding transmural healing better could help doctors provide more targeted and effective treatments in the future.
Puntos clave
- This study is for adults with active Crohn's disease.
- It tests a medicine called mirikizumab to see if it heals the deep layers of the bowel.
- MRI scans will be used to check for internal healing.
- You will receive careful medical monitoring if you participate.
- Puede retirarse del estudio en cualquier momento.
¿Quién puede ser elegible?
To be part of this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Crohn's disease. You should also be experiencing symptoms, such as needing to go to the toilet more than three times a day or having tummy pain. Doctors will also check with a special MRI scan to see if you have inflammation deep within your bowel wall.
There are some reasons why you might not be able to join. For example, if you've recently used certain other powerful medicines for Crohn's, or if you have specific other health conditions like an active infection, a history of certain surgeries on your bowel, or if you are pregnant or breastfeeding. You also can't have certain medical conditions that would make an MRI scan unsafe, or lack health insurance.
If you're unsure whether you fit the criteria, it's always best to discuss it with your doctor or the study team. They can help you understand all the details and decide if this study might be right for you.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Are you 18 to 75 years old?
- Do you have Crohn's disease and currently have symptoms like tummy pain or frequent bowel movements?
- Have you *not* had specific powerful treatments for Crohn's in the past or very recently?
- ¿Puedes someterte a una resonancia magnética?
- ¿No estás embarazada o amamantando?
¿En qué consiste la participación?
If you decide to take part in this study, you would first have a full medical check-up to make sure the study is suitable for you. You would then receive the study medicine, mirikizumab, which could be given either through a drip into your arm or as an injection under your skin, depending on what the study team advises. You would have regular visits to the clinic for medical examinations, blood tests, and to discuss any symptoms or side effects you might be experiencing.
Crucially, you would also have MRI scans at different points during the study. These scans help doctors see if your bowel is healing on the inside. You'll be asked to keep a record of your symptoms. The total length of your participation in the study would be explained to you in detail by the study team.
Riesgos y beneficios potenciales
Ubicaciones (6)
- CHU de Brest - Hôpital de la Cavale BlancheCódigo postal verificadoBrest, France· Aún no reclutando
- CHU de Clermont Ferrand - Hôpital d'EstaingCódigo postal verificadoClermont-Ferrand, France· Reclutamiento
- CHU de Nîmes CarémeauCódigo postal verificadoNîmes, France· Aún no reclutando
- Institut Mutualiste MonsourisCódigo postal verificadoParís, Francia· Aún no reclutando
- CHU de Toulouse - Hôpital RangueilCódigo postal verificadoToulouse, France· Aún no reclutando
- CH de ValenceCódigo postal verificadoValence, France· Aún no reclutando
Preguntas comunes
¿Qué es la enfermedad de Crohn?
Crohn's disease is a condition that causes swelling and irritation (inflammation) in your digestive system, which can lead to tummy pain, diarrhoea, and tiredness.
What does 'transmural healing' mean?
It means the medicine helps to heal the inflammation deep within the wall of your bowel, not just on the inside surface. This deeper healing is thought to be very beneficial for Crohn's disease.
What is mirikizumab?
Mirikizumab is a specific type of medicine used to treat inflammatory conditions like Crohn's disease. It works by targeting certain immune responses in your body.
Will I get the medicine through a drip or an injection?
The study is looking at both ways of giving mirikizumab – either into a vein (like a drip) or as an injection under the skin. The study team will tell you which method applies to you.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, you can leave the study at any time without having to give a reason. This won't affect your regular medical care.
Cómo obtener más información
Julie MUSSOT
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.