Phase 4 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from 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 18 and 65 years old
• You have been diagnosed with Crohn's disease based on tests such as scans, endoscopy, and lab results
• You have been treated with a TNF-alpha blocker medication (such as infliximab, adalimumab, or a similar drug) for at least 12 weeks at a standard dose, and your doctor believes the medication has helped somewhat but not enough, and that there may still be room to improve your response to it
• Your Crohn's disease is currently active, with a disease activity score in a specific range (CDAI between 150 and 450), plus at least one sign of active inflammation confirmed by endoscopy, blood tests, stool tests, or imaging scans
• Blood or other samples can be taken at the start of the study to measure the levels of your current medication in your body
• You understand what the study involves and have agreed in writing to take part

Who may not be able to join:

• Your current medication (TNF-alpha blocker) showed absolutely no benefit at all during the initial treatment phase, and your doctor believes it simply is not working for you
• Lab tests have shown that your body has developed antibodies against your current medication, leaving little or no drug in your system, making continued use of that medication unsuitable
• Your current symptoms appear to be caused by something other than inflammation — for example, irritable bowel syndrome or a bacterial overgrowth — with no objective signs of active inflammation found
• You have previously taken a JAK inhibitor medication (such as upadacitinib), are allergic to any part of the study treatment, or have another clear medical reason why the study treatment would not be safe for you
• You have serious bowel complications such as an uncontrolled abscess in the abdomen, a hole in the bowel, a severe blockage needing urgent surgery, or a severe active fistula
• You have had major bowel surgery, a stoma created, or another major abdominal operation within the past 3 months, and your doctor believes this could affect how the study results are measured
• You have an active infection or are at high risk of a serious infection, including active tuberculosis, uncontrolled bacterial, fungal, or viral infections, active shingles, hepatitis B reactivation, HIV, or a significant condition that weakens your immune system
• You have serious problems with your liver, kidneys, heart, or another major organ, or another serious health condition your doctor feels makes participation unsafe
• You have a history of bowel cancer, or currently have any other cancer that could affect the safety or results of this study
• You are pregnant, breastfeeding, or planning a pregnancy and are unwilling to use effective contraception throughout the study
• You have a serious mental health or neurological condition that might affect your ability to consent, follow the treatment plan, or complete the study
• You have taken part in another clinical intervention study within the past 30 days, where that study's treatment could affect this study's results
• Your doctor has any other concern that makes them feel it would not be appropriate for you to join this study (confirm with trial site)

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