Purpose

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).

Condition

Eligibility

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

Inclusion Criteria

  • Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
  • Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
  • If female, must meet the contraception requirements.

Exclusion Criteria

  • Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
  • Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
  • Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
  • Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
  • Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
  • Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

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
Experimental
Mirikizumab Dose #1
Mirikizumab Dose #1 administered subcutaneously (SC)
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose #2
Mirikizumab Dose #2 administered intravenously (IV)
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
Placebo Comparator
Placebo
Placebo administered SC
  • Drug: Placebo
    Administered SC
    Other names:
    • LY3074828

Recruiting Locations

Tulane University School of Medicine
New Orleans, Louisiana 70112 2715
Contact:
504-588-5405

More Details

NCT ID
NCT03524092
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

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.