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Purpose

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of UC for at least 3 months prior to baseline. - Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). - Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. - If female, must meet the contraception requirements.

Exclusion Criteria

  • Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis). - Participants with a previous colectomy. - Participants with current evidence of toxic megacolon. - Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Intravenous (IV) Every 4 Weeks (Q4W) 		Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Drug: Placebo
    Administered IV
Experimental
300 Milligram (mg) Mirikizumab IV Q4W 		300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
Placebo Comparator
Placebo IV Q4W Maximum Extended Enrollment (ME2) 		Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Drug: Placebo
    Administered IV
Experimental
300 mg Mirikizumab IV Q4W ME2 		300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828

More Details

Status
Active, not recruiting
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.