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 75 years old
• You have been diagnosed with Crohn's disease based on test results such as a camera examination of your gut, scans, or tissue samples
• Your Crohn's disease is currently active, shown by a specific disease activity score and at least one sign of inflammation — such as from a gut camera, an ultrasound or scan, or a blood or stool test
• You are about to start treatment with a specific type of medication called an IL-23 inhibitor (guselkumab or risankizumab) as part of your normal care, and you have never taken this type of medication before
• You may have taken other types of biologic medicines before (such as TNF inhibitors, vedolizumab, or ustekinumab), or you may never have taken a biologic medicine at all
• If you are currently taking other medications for Crohn's disease (such as steroids or immunosuppressants), your doses have been stable for at least 2 to 4 weeks before joining
• You are able to understand what the study involves, sign a consent form, and attend follow-up visits and provide samples as required
• If joining the comparison group (for people starting TNF inhibitor therapy instead): you must never have taken any biologic or similar targeted medicine before, and you must be about to start a TNF inhibitor as part of your normal care (confirm with trial site)

Who may not be able to join:

• You have previously taken any IL-23 inhibitor medication, including guselkumab, risankizumab, or mirikizumab
• You have been diagnosed with a different type of inflammatory bowel disease (such as ulcerative colitis), or another gut condition that could be confused with Crohn's disease (such as intestinal tuberculosis or radiation damage to the bowel)
• Your Crohn's disease is so severe that you urgently need surgery, or you have serious complications such as a bowel perforation, a severe infected fistula, or a complete bowel blockage
• You have an active infection, untreated latent tuberculosis, active hepatitis B or C, HIV, or a history of serious or repeated infections
• You currently have or have previously had cancer, unless it was a limited skin cancer or an early-stage cervical condition that was fully treated with no signs of return
• You are pregnant, breastfeeding, or planning to become pregnant during the study
• You have a serious condition affecting your heart, liver, or kidneys, an uncontrolled autoimmune disease, or a mental health condition that may affect your ability to take part — your doctor will assess this (confirm with trial site)
• You are unable to attend follow-up visits, are unlikely to follow the study requirements, or have recently taken part in another clinical trial involving a treatment intervention

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