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A Study of Mirikizumab in Participants With Crohn's Disease

Jeffrey Roberts

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Jeffrey Roberts


Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

Ages Eligible for Study:    18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:    All

Inclusion Criteria:

  • Diagnosis of CD for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
  • Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome
  • Have a stoma or ostomy
  • Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
  • Have ever received any monoclonal antibodies binding IL-23

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  • Jeffrey Roberts changed the title to A Study of Mirikizumab in Participants With Crohn's Disease

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