Phase 2 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 are between 12 and 80 years old (note: at Boston Children's Hospital, the maximum age is 30)
• You have been diagnosed with Crohn's disease based on standard medical tests including imaging, camera procedures, and tissue samples
• You have moderate-to-severe Crohn's disease, measured using a standard scoring system (people with an ileostomy or colostomy may also be eligible)
• A camera examination of your bowel has shown active inflammation at a certain level of severity
• You have tried at least one standard treatment (such as steroids, azathioprine, or biologic medications like TNF blockers) and it either did not work or you could not tolerate it — or you are unable to reduce your steroid dose without your disease coming back
• Any medications you are currently taking have been at a stable dose as required by the study
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 2 weeks before starting the study drug, and both men and women who could have children must agree to use reliable birth control during treatment and for six months afterward
• You are able to give your own informed consent, or a legal guardian can provide consent on your behalf if you are under 18 or have a mild intellectual disability

Who may not be able to join:

• You have been diagnosed with ulcerative colitis or indeterminate colitis (a related but different bowel condition)
• You urgently need surgery, an endoscopy procedure, or a radiology procedure for a serious complication such as a perforation, severe infection, or abscess
• You have a history of bowel cancer or pre-cancerous changes in your bowel
• You have tested positive for a gut infection called Clostridioides difficile (C. diff) using a specific two-step test
• You currently have a significant active infection
• Your blood test results show serious abnormalities, such as very low red blood cells, white blood cells, or platelets, or problems with your kidney or liver function, or an abnormal thyroid test (confirm with trial site for specific values)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• You have tested positive for tuberculosis (TB)
• You have received a biologic medication within 4 weeks before starting the study drug
• You have taken part in another experimental drug study too recently (within a specific timeframe depending on that drug)
• You have been diagnosed with cancer in the last 5 years (excluding certain minor skin cancers)
• You are allergic to any ingredient in the study drug
• You are pregnant or breastfeeding
• You are unable or unwilling to follow the study requirements, or consent cannot be properly obtained
• You have previously been treated with a drug called IL-2
• You have uncontrolled chest pain (angina) or severe heart failure

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