Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sofia G Verstraete
Photo of Sofia G Verstraete
Sofia G Verstraete

Description

Summary

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Official Title

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

Keywords

Crohn's Disease Crohn Disease Mirikizumab Mirikizumab SC Mirikizumab IV and SC

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
  • If female, participant must meet the contraception requirements

You CAN'T join if...

  • Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

  • Participants must not have developed adenomatous polyps during the originator study that have been removed prior to the start of this study.
  • Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
  • Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Locations

  • UCSF Medical Center at Mission Bay not yet accepting patients
    San Francisco California 94158 United States
  • California Medical Research Group accepting new patients
    Northridge California 91324 United States

Lead Scientist at UCSF

  • Sofia G Verstraete
    Assistant Professor, Pediatrics. Authored (or co-authored) 18 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
ID
NCT04232553
Phase
Phase 3
Study Type
Interventional
Last Updated