Testing Mirikizumab for crohn disease

Exclusion

• −Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.
• −Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.
• −Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.
• −HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.
• −CD-related complications:
• −Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.
• −Short bowel syndrome.
• −Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
• −Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \> 2 cm.
• −Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.
• −Abscess located \< 2 cm in relation to the stricture.
• −Toxic megacolon.
• −Malignancies or history of malignancy within 5 years of the initial screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• −Liver chemistry parameters that exceed the following thresholds:
• −ALT or AST \> 2 × ULN
• −Alkaline phosphatase \> 2.5 × ULN
• −Total bilirubin \> 1.5 × ULN
• −Concomitant use of the following medications during the screening period or throughout the study:
• −Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.
• −Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.
• −JAK inhibitor within 4 weeks prior to screening and throughout the study.
• −IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors.
• −Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s usual standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → at screening.
• −Concurrent or previous participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
• −Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.
• −Systemic or opportunistic infections including:
• −Known active or latent TB; if a negative test result is available in the 12 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, confirmatory testing (per standard of care) is not required before Day 0.
• −Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).
• −Active CMV infection, as per investigator judgement
• −Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1.
• −Prior enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the current study and had received study treatment.
• −Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, as determined by the investigator.
• −Unwillingness to withhold protocolProtocolThe detailed plan a study must follow.Read more →-prohibited medications during the trial.
• −History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• −Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).