RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

This research is looking at a new medicine called Afimkibart for children and teenagers (aged 2 to 17 years old) who have moderate to severe Crohn's disease. This is for young people whose Crohn's hasn't improved enough with their usual medicines. The study wants to find out if Afimkibart can help reduce symptoms and improve their condition, how safe it is to use, and how the medicine affects the body over time. It's a large study where some participants will receive the active medicine and some a dummy medicine, without anyone knowing which is which, to get the clearest results.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

100

Start

31 Aug 2026

Estimated completion

30 May 2031

Moderately to Severely Active Crohns Disease

What is this study about?

Crohn's disease is a long-term condition where parts of the digestive system become inflamed. This can cause tummy pain, severe diarrhoea, tiredness, and weight loss. For some young people, their Crohn's disease symptoms can be quite severe and don't get much better with standard treatments. This means they continue to feel unwell, which can affect their schooling and everyday life.

This study is testing a new medicine called Afimkibart. It's hoped this medicine might offer a new way to help young people with Crohn's disease who haven't found enough relief from other treatments. Researchers want to see if Afimkibart can help to calm down the inflammation in the gut, reduce symptoms, and generally improve how young people feel and function. This is important because finding more effective and safe treatments can make a big difference to the lives of children and teenagers living with this challenging condition.

The study is in its 'Phase 3', which means it's one of the final stages of testing before a medicine might be approved for wider use. It's a 'double-blind' study, meaning neither the participants nor the doctors will know who is receiving the new medicine and who is receiving a placebo (a dummy medicine). This helps to ensure the results are as fair and accurate as possible, showing us the true effect of Afimkibart.

Key takeaways

A new medicine, Afimkibart, is being tested for children with Crohn's disease.
This study is for children aged 2-17 whose Crohn's hasn't responded to other treatments.
It aims to check if Afimkibart is safe and effective.
Participants will receive either the new medicine or a dummy medicine.
Close medical monitoring will be provided throughout the study.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, children and teenagers typically need to be between 2 and 17 years old and weigh at least 10 kilograms (about 1 stone 8 pounds). They must have moderate to severe Crohn's disease that has been officially diagnosed by a camera test (endoscopy). Their doctors will use special scores to confirm their Crohn's is active enough for the study.

Crucially, their Crohn's disease must not have responded well to, or they couldn't tolerate, at least one other type of Crohn's treatment they've tried in the past. This could include common medicines like aminosalicylates, steroids, or immunosuppressants, or newer 'advanced' therapies.

However, some young people would not be able to join. This includes if they have certain other gut conditions like ulcerative colitis, a very rare genetic form of bowel disease, or have had many previous bowel operations. Also, if they have certain complications like severe bowel narrowing or abscesses, or other specific health issues, they wouldn't be able to take part for their safety.

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.

Is your child aged between 2 and 17 years old?
Does your child have moderate to severe Crohn's disease confirmed by a camera test?
Has your child's Crohn's not improved enough with at least one other treatment?
Does your child not have other specific gut conditions like ulcerative colitis or severe blockages?
Does your child weigh at least 10 kilograms (about 1 stone 8 pounds)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. These visits will include checks of your child's health, blood tests, and possibly repeats of the camera test (endoscopy) to see how their Crohn's disease is responding. Your child would receive the study medicine, Afimkibart, or a placebo, which might be given as an injection or infusion. The doctors and nurses on the study team will explain how and when the medicine is given.

The study is likely to involve several months of active treatment, followed by a period where your child's condition continues to be monitored. The full duration of participation, including all follow-up, could extend for quite a while, and the study team will provide a detailed schedule covering all appointments, tests, and medication administration. They will make sure you understand everything involved before you decide to take part.

Potential risks and benefits

There are potential benefits to joining this study. Your child might receive a new treatment that could help improve their Crohn's disease symptoms when other treatments haven't worked well. They will also receive very close medical care and monitoring from a team of specialists. However, as with any new medicine, there are potential risks. The new medicine might cause side effects, some of which could be serious, or it might not work for your child. The medical procedures involved in the study, like blood tests or endoscopies, also carry their own small risks. It's really important to remember that participating in any clinical trial is always voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (7)

Royal Children's Hospital
Verified postcode
Parkville, Australia· Recruiting
Perth Children's Hospital
Verified postcode
Nedlands, Australia· Recruiting
National Taiwan University Hospital
Verified postcode
Taipei, Taiwan· Recruiting
Chulalongkorn University
Verified postcode
Bangkok, Thailand· Recruiting
Siriraj Hospital
Verified postcode
Bangkok, Thailand· Recruiting
Ramathibodi Hospital
Verified postcode
Bangkok, Thailand· Recruiting
Sheffield Childrens Hospital
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a condition where parts of the digestive system get inflamed and swollen, causing symptoms like tummy pain and diarrhoea.

What is Afimkibart?

Afimkibart is a new medicine being tested to see if it can help reduce inflammation and symptoms in children with Crohn's disease.

Will my child definitely get the new medicine?

Not necessarily. In this type of study, some participants receive the new medicine and others receive a placebo (dummy medicine).

How long will the study last?

The study will involve initial treatment and then continued monitoring. The full commitment will be explained by the study team, but it could last quite a while.

Can we stop participating if we change our mind?

Yes, taking part is completely voluntary. You can decide to withdraw your child from the study at any time without it affecting their care.

How to find out more

Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

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