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.
Single group
Mirikizumab
DrugMirikizumab is an IL-23 antagonist.
To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD
Achievement of radiologic response (defined by a ≥ 50% improvement in stricture length and no worsening of prestenotic small bowel diameter OR a ≥ 50% improvement in prestenotic small bowel diameter and no worsening of stricture length)
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in S PRO score
To evaluate the efficacy of mirikizumab in health-related quality of life in participants with inflammatory stricturing CD
Change from baseline in S PRO score
To evaluate the efficacy of mirikizumab in radiologic disease activity in participants with inflammatory stricturing CD
Change from baseline in S PRO score
To evaluate the efficacy of mirikizumab in endoscopic disease activity in participants with inflammatory stricturing CD
Change from baseline in S PRO score
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