RecruitingPHASE4INTERVENTIONAL

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.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Enrolment target

Start

11 May 2026

Estimated completion

01 Nov 2028

Crohn Disease (CD)

What is this study about?

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.

Key takeaways

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.
You can withdraw from the study at any time.

Who may be eligible?

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.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

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?
Are you able to have an MRI scan?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new or different treatment for your Crohn's disease and having very close monitoring of your health by a specialist team. However, there are also potential risks, as with any medicine. Mirikizumab might cause side effects, and you would need to attend regular appointments and have scans. All the possible risks and side effects will be explained to you fully before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

CHU de Brest - Hôpital de la Cavale Blanche
Verified postcode
Brest, France· Not yet recruiting
CHU de Clermont Ferrand - Hôpital d'Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU de Nîmes Carémeau
Verified postcode
Nîmes, France· Not yet recruiting
Institut Mutualiste Monsouris
Verified postcode
Paris, France· Not yet recruiting
CHU de Toulouse - Hôpital Rangueil
Verified postcode
Toulouse, France· Not yet recruiting
CH de Valence
Verified postcode
Valence, France· Not yet recruiting

Common questions

What is Crohn's disease?

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.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason. This won't affect your regular medical care.

How to find out more

Julie MUSSOT

jmussot@getaid.org +33 6 27 49 29 10 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.