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 an adult aged 18 or older and are not currently pregnant or breastfeeding
• You have been diagnosed with Crohn's disease (CD) affecting the small intestine (ileum) or both the small intestine and colon, confirmed at least 3 months before the screening visit
• You have at least one area of narrowing (stricture) in the last part of your small intestine that can be seen by a scope and confirmed by a special type of MRI scan, meeting specific size and thickness measurements
• You experience stomach pain after eating and/or have had to limit how much or what types of food you eat
• Your bowel narrowing symptoms are manageable, and you are not expected to need hospitalisation, a procedure, or surgery during the study period, and your weight has been stable for the past 4 weeks
• You have been taking oral steroid tablets (such as prednisone up to 20mg/day or budesonide up to 9mg/day) for at least 4 weeks before screening, and you are willing to gradually reduce your steroid dose starting 8 weeks into the study
• You are on a stable Crohn's disease treatment (such as certain anti-inflammatory medicines, immunosuppressants, or anti-diarrhoeal drugs) and agree to keep taking it throughout the study
• You are using appropriate contraception in line with the study drug's guidelines and local recommendations
• You have read and signed a form giving your informed consent to participate

Who may not be able to join:

• You have been diagnosed with a different type of bowel condition, such as ulcerative colitis, radiation colitis, microscopic colitis, or other types of colitis not related to Crohn's disease
• You have had extensive removal of your small intestine, short bowel syndrome, a stoma (such as an ileostomy or colostomy), or an ileoanal pouch
• You have inactive fistulas (abnormal tunnels) near a stricture, an untreated abscess (pocket of infection) near the stricture or in the abdomen or anal area, or a serious complication called toxic megacolon
• You have had major surgery (requiring general anaesthetic) within 8 weeks before screening or have surgery planned during the study
• You have had a cancer diagnosis within the past 5 years (with some exceptions for certain fully treated skin or cervical conditions — confirm with trial site)
• You have serious liver disease or abnormal liver blood test results above certain levels
• You are currently taking or have recently taken certain medicines, including cyclosporine, tacrolimus, biological therapies (such as anti-TNF drugs or ustekinumab), JAK inhibitors, or IL-23 inhibitors (confirm timing details with trial site)
• Your vaccinations are not up to date for your age group
• You are currently in or have recently taken part in another clinical trial involving an experimental treatment (within 4 weeks or 5 half-lives, whichever is longer)
• You have previously been treated with any anti-fibrotic therapy (medicines targeting scar tissue), including experimental ones
• You have an active or latent (inactive) tuberculosis infection, HIV, active hepatitis B or C, a current C. difficile gut infection, active CMV infection, or another serious ongoing or recurring infection
• You have a known allergy or severe reaction to the study drug (mirikizumab) or any of its ingredients
• You have a reason why you cannot have an MRI scan, or a suspected allergy to MRI contrast dye or antispasmodic medicines used during the scan
• You have previously enrolled in this same study and received the study treatment
• You have any other significant medical condition, mental health condition, or abnormal test result that, in the doctor's opinion, could make participation unsafe or affect the study results
• You are unwilling to stop taking any medicines that are not allowed during the trial

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