Phase 3 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You weigh at least 10 kg (about 22 pounds) at the time of screening and at the start of the trial.
• You have been diagnosed with moderate to severe Crohn's Disease in children or teens, confirmed by specific activity scores and a camera examination of the gut (colonoscopy) showing inflammation.
• Your Crohn's Disease diagnosis has been confirmed by colonoscopy during the screening period, with biopsy results supporting the diagnosis, and with no signs of current infection or abnormal/cancerous cells in the colon.
• Previous treatments (such as steroids, immune-suppressing medicines, or biologic therapies) have not worked well enough for you, stopped working, caused intolerance, or cannot be used for medical reasons. (Note: if you are in the US or South Korea, you must specifically have had an inadequate response, loss of response, or intolerance to at least one anti-TNF biologic medication.)

Who may not be able to join:

• You were first diagnosed with Crohn's Disease before the age of 2.
• You currently have an active abscess (a pocket of infection) in the abdomen or around the back passage.
• You currently have bowel blockages causing symptoms.
• More than 2 out of 5 specific sections of your intestine are missing.
• You have a stoma (ostomy bag) or an internal pouch connected to your bowel.
• You have had bowel surgery in the last 3 months, or more than 3 bowel surgeries in total.
• You are participating in Japan and have a positive or repeatedly unclear test result for a specific fungal infection screening (confirm with trial site).
• You currently have ulcerative colitis, indeterminate colitis, or a rare inherited form of inflammatory bowel disease.
• You have a history of a severe, rapidly worsening bowel condition called fulminant colitis or toxic megacolon.
• You have had a hole (perforation) develop in your gut (unless caused by appendicitis or a physical injury), a history of diverticulitis, or other conditions that significantly raise the risk of gut perforation, such as a history of the bowel twisting or telescoping.
• You currently have any condition where your immune system does not work properly from birth (primary immune deficiency).
• You have a condition that affects how your body absorbs medicines, such as short bowel syndrome or a history of gastric bypass surgery. (Note: a history of gastric banding alone does not exclude you — confirm with trial site.)

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