This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.
Nonpregnant, nonlactating adults, ≥ 18 years of age.
Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.
Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND
Bowel wall thickening (≥ 25% relative to adjacent bowel; AND
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.
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.