Take an investigational medication to treat moderate to severe Crohn's disease

Take an investigational medication to treat moderate to severe Crohn's disease | stella

What is this trial?

This trial is testing a medication called to see if it can help children with moderate to severe Crohn's disease feel better and have fewer symptoms. is already approved for adults with this condition, but researchers want to learn if it works safely in children ages 2 to 17 who haven't improved with other treatments. The study will track how the medication moves through children's bodies and measure how well it reduces inflammation in the digestive system.

Crohn's disease in children can cause severe diarrhea, belly pain, bleeding, weight loss, and fever—and some children don't respond well to current treatments. This trial will help doctors understand whether this medication can be a safe and effective option for children whose disease isn't controlled by other therapies.

Do you qualify?

You likely qualify if…

you are between 2 and 17 years old
you have been diagnosed with moderate to severe Crohn's disease confirmed by a scope exam and blood work
your symptoms have not improved with or you have had side effects from other medications like steroids, immunosuppressants, or biologic therapies
you do not have other types of inflammatory bowel disease like ulcerative colitis
you do not have a weakened immune system or hereditary fructose intolerance

You likely don't qualify if…

you have had Crohn's disease diagnosed before age 2
you have active infections, an abdominal abscess, or bowel blockages that might need surgery
you have had more than 3 surgical bowel removals in your lifetime or a bowel removal in the past 3 months
you have a diagnosis or suspected diagnosis of a primary immunodeficiency disorder
you have an allergic reaction or significant sensitivity to the study medication or its ingredients

What participation looks like

Your child would participate for up to about 5 years with regular clinic visits and blood tests. The study has three phases: first, a 12-week induction period where your child receives the medication through an IV; second, a 52-week maintenance phase where your child receives shots under the skin and is randomly assigned to one of two doses (neither you nor the doctors will know which dose); and third, an optional long-term extension lasting up to 4 years where the dose is adjusted based on how well the medication is working. You'll attend regular hospital or clinic visits for check-ups, blood work, and imaging to monitor your child's response to treatment.

AI-generated summary from trial data · Jun 26, 2026 · Not medical advice

Testing a new medication for children with moderate to severe Crohn's disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(85 sites)