A Phase 3 Multicenter Randomized Double-Blind Parallel Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ulcerative Colitis
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Able to provide written informed consent
    2. Female participants of child bearing potential have a negative pregnancy test and agree to abstinence or use 2 effective methods of contraception
    3. Subjects diagnosed with Ulcerative Colitis (UC)
    4. Have venous access sufficient to allow blood sampling and IV administration as per the protocol.
    5. Subjects who have evidence of UC extending beyond the rectum (more proximal to the rectosigmoid junction)
    6. Subjects who have documentation of a surveillance colonoscopy for pancolitis, left-sided colitis or primary sclerosing cholangitis
    7. Subjects who have an inadequate response to, loss of response to or intolerant to at least one of the following: corticosteroids or immunomodulators
    8. Subjects who have inadequate response to, loss of response to or intolerant toto biologic therapy
    9. Subjects who are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.

You may not be eligible for this study if the following are true:

    1. Subjects who have a current diagnosis of Crohn’s disease, inflammatory bowel disease- unclassified (IBD-U), or UC proctitis
    2. Subjects have an inherited immunodeficiency syndrome or a known monogenic cause of UC-like colonic inflammation
    3. Subjects who previously had bowel resection or intestinal or intra-abdominal surgery
    4. Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
    5. Any history or currently have cancer, adenoma, dysplasia
    6. Those with active tuberculosis or had tuberculosis
    7. Subjects who received a Bacillus Calmette-Guerin (BCG) vaccination
    8. Subjects who have or test positive for human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), hepatitis B or hepatitis C infection
    9. Subjects with lymphoma, leukemia, or any malignancy
    10. Those currently enrolled in any other clinical study involving an investigational product
    11. Have previously completed or discontinued from this study or any other study investigating mirikizumab
    12. Have had extra-abdominal surgery and have not recovered fully following surgery
    13. Subjects with the presence of significant uncontrolled neuropsychiatric disorder or judged at risk of suicide in the opinion of the investigator
    14. Solid organ transplant or hematopoietic stem cell transplantation
    15. Unwilling or unable to comply with the use of a data collection device or other study procedures
    16. Pregnant, breastfeeding or planning pregnancy
    17. Drug or alcohol abuse



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