NCT05923073

Who might be able to join this trial:

• You (or your child) must have been diagnosed with Crohn's Disease (including a type that causes tunnels or tracts, called fistulizing Crohn's Disease), affecting the large intestine, small intestine, or both, confirmed at some point in the past through clinical assessment, a camera examination of the gut, and tissue samples.
• The Crohn's Disease must currently be moderately to severely active, based on a specific scoring system for children called the Pediatric Crohn's Disease Activity Index (PCDAI), with a score of 30 or higher.
• A recent camera examination of the gut (within 1 month of starting the study) must show signs of active Crohn's Disease, with a score of 6 or higher on a specific scale (or 4 or higher if the disease only affects the lower part of the small intestine).
• Previous treatments must not have worked well enough, must have stopped working over time, or must have caused side effects — this includes medications that calm the immune system, steroids (taken by mouth or given through a drip), biologic medicines, or a specific newer type of drug called a JAK inhibitor; OR you/your child must have become dependent on steroids; OR a liquid-only diet (called exclusive enteral nutrition) must not have worked well enough.

Who may not be able to join:

• You/your child must not have certain complications of Crohn's Disease, such as narrowings in the gut causing symptoms, short bowel syndrome, or other problems that are likely to need surgery.
• You/your child must not currently have a pocket of infection (abscess) related to the condition.
• You/your child must not have had surgery to remove part of the bowel within the last 26 weeks, or any other surgery inside the abdomen within the last 12 weeks before the study begins.

Important: Always verify eligibility with the trial site directly before applying.