A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company
Summary
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening. * Have moderate to severe UC. * Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment. * Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report. Exclusion Criteria: * Have Crohn's disease, Inflammatory Bowel…
Interventions
- DrugMirikizumab IV
Administered IV
- DrugMirikizumab SC
Administered SC
Locations (34)
- University of California, San FranciscoSan Francisco, California
- Children's Center for Digestive Health Care, LLCAtlanta, Georgia
- Riley Childrens HospitalIndianapolis, Indiana
- Washington UniversitySt Louis, Missouri
- Icahn School of Medicine at Mount SinaiNew York, New York
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio