RecruitingPHASE3INTERVENTIONAL

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

This study is testing a new medicine, mirikizumab, for children and teenagers aged 2 to 17 years who have Crohn's disease. Researchers want to see if mirikizumab can help manage the condition when other treatments haven't worked well enough. They will also check its safety, how well bodies cope with it, and how much of the medicine gets into the body. Participants will be carefully screened and then randomly assigned to receive either mirikizumab or another treatment. The study will last about 74 weeks and involve regular check-ups, helping doctors understand if this new medicine could be a good option for young people with Crohn's.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

Start

13 Mar 2024

Estimated completion

01 Apr 2028

Crohn's 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 various symptoms like tummy pain, diarrhoea, and weight loss. For many young people with Crohn's, finding a treatment that works well and has manageable side effects can be a challenge. That's why researchers are studying new medicines like mirikizumab.

This particular study, officially called A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease, aims to understand if mirikizumab is a safe and effective option for children and teenagers with Crohn's disease. They are specifically looking at young people whose Crohn's hasn't responded well to other treatments they've tried. The study will carefully check how well the medicine works to reduce symptoms, how safe it is, and how the body handles the medicine.

By taking part, children and their families can help doctors learn more about mirikizumab. This research is important because it could lead to new ways to help young people with Crohn's disease feel better and lead more comfortable lives, especially if their current treatments aren't working as well as hoped.

Key takeaways

Tests a new medicine (mirikizumab) for children and teenagers with Crohn's disease.
Aims to help those whose Crohn's hasn't responded well to other treatments.
Studies the medicine's safety, effectiveness, and how the body uses it.
Lasts about 74 weeks with up to 19 clinic visits.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, your child must have been diagnosed with Crohn's disease, including specific types like active colitis or ileocolitis. Their Crohn's disease must also be considered moderately to severely active when they join the study, as shown by certain medical scores and an endoscopy (a procedure to look inside the digestive system) within one month of starting the medicine.

It's also important that your child has already tried and not responded well to, or couldn't tolerate, at least one other treatment for Crohn's disease. This could include medicines like immunomodulators, steroids, certain biologic therapies, or JAK inhibitors.

However, your child cannot join the study if they have certain complications of Crohn's, such as narrowings in the bowel that cause problems, or if they've recently had surgery on their bowel or tummy. They also cannot have any abscesses (pockets of infection) at the time of screening. The study is open to both boys and girls aged between 2 and 17 years.

Quick self-check

Is your child aged between 2 and 17 years?
Does your child have a confirmed diagnosis of Crohn's disease?
Is your child's Crohn's disease currently moderately to severely active?
Has your child tried at least one other Crohn's medicine that didn't work well or caused problems?
Does your child NOT have complications like bowel blockages or abscesses?
Has your child NOT had recent bowel surgery within the last 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they would be carefully checked to make sure they are suitable. Then, they would be randomly assigned to receive either mirikizumab or another treatment. This is like flipping a coin to decide, making sure the comparison between the treatments is fair.

The study starts with a 12-week 'induction period' where the medicine aims to bring symptoms under control. After this, there's a 'maintenance period' lasting until week 52, where the medicine helps keep symptoms settled. Finally, there's a safety follow-up period for up to 16 weeks to ensure everything is okay. In total, the study will last about 74 weeks (around 1 year and 5 months) and could involve up to 19 visits to the clinic for check-ups and assessments. These visits will help the doctors monitor your child's health and how the medicine is working.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as gaining access to a new medicine that might help manage your child's Crohn's disease when other treatments haven't worked. Your child would also receive close medical attention and monitoring throughout the study. However, there are always potential risks with new medicines, including side effects that are not yet fully known or that the treatment may not work for your child. The study will carefully monitor for any side effects. Remember, participating is entirely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (81)

Cedars Sinai Medical Center
Los Angeles, United States· Not yet recruiting
Connecticut Children's Medical Center
Hartford, United States· Recruiting
Emory University
Atlanta, United States· Recruiting
Children's Center for Digestive Health Care, LLC
Atlanta, United States· Recruiting
Riley Childrens Hospital
Indianapolis, United States· Recruiting
Boston Children's Hospital
Boston, United States· Not yet recruiting
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, United States· Not yet recruiting
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, United States· Recruiting
Icahn School of Medicine at Mount Sinai
New York, United States· Recruiting
Columbia University Medical Center/New York Presbyterian
New York, United States· Recruiting
Childrens Medical Center
Dayton, United States· Recruiting
Children's Hospital of Philadelphia
Philadelphia, United States· Recruiting

+69 more sites — see the official record for the full list.

Common questions

What exactly is Crohn's disease?

Crohn's disease is a lifelong condition that causes parts of your digestive system to become inflamed, leading to symptoms like tummy pain, diarrhoea, and tiredness.

What is mirikizumab?

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

How long will the study last?

The study will last for about 74 weeks (around 1 year and 5 months), including treatment and follow-up periods.

Will my child definitely receive mirikizumab?

Not necessarily. Participants will be randomly assigned to either receive mirikizumab or another intervention, like drawing lots, to ensure a fair comparison.

Can we stop participating at any time?

Yes, you have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

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