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Purpose

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Condition

Eligibility

Eligible Ages
Between 15 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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) or short bowel syndrome - Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery - Have a stoma, ileoanal pouch 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.
  • Drug: Placebo
    Administered IV
  • Drug: Placebo
    Administered SC
Experimental
300 mg Mirikizumab 		Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Active Comparator
90 mg Ustekinumab 		Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)
  • Drug: Ustekinumab
    Administered IV
  • Drug: Ustekinumab
    Administered SC
Experimental
300 mg Mirikizumab (Adolescents) 		Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.