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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

NCT05784246 · Eli Lilly and Company
In plain English

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Official title
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
About this study
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility criteria
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 Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis. * Have immune deficiency syndrome. * Previous bowel resection or intestinal surgery. * Evidence of toxic megacolon. * History or current evidence of cancer of the gastrointestinal tract.
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: child
Timeline
Starts: 2023-11-22
Estimated completion: 2026-08
Last updated: 2026-03-03
Interventions
Drug: Mirikizumab IVDrug: Mirikizumab SC
Primary outcomes
  • Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders (Baseline to Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (34)
University of California, San FranciscoCompleted
San Francisco, California, United States
Children's Center for Digestive Health Care, LLCCompleted
Atlanta, Georgia, United States
Riley Childrens HospitalCompleted
Indianapolis, Indiana, United States
Washington UniversityCompleted
St Louis, Missouri, United States
Icahn School of Medicine at Mount SinaiCompleted
New York, New York, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
UZACompleted
Edegem, Belgium
UZ LeuvenCompleted
Leuven, Belgium
The Hospital for Sick ChildrenCompleted
Toronto, Canada
Hôpital Necker - Enfants MaladesCompleted
Paris, France
Universitaetsmedizin der Johannes Gutenberg-Universitaet MainzCompleted
Mainz, Germany
LMU-Campus InnenstadtCompleted
München, Germany
Helios Klinikum WuppertalCompleted
Wuppertal, Germany
Shaare ZedekCompleted
Jerusalem, Israel
Hadassah University Hospital, Ein KeremCompleted
Jerusalem, Israel
Schneider Children's Medical CenterCompleted
Petah Tikva, Israel
King Fahad Medical CityCompleted
Rishon LeZiyyon, Israel
Azienda Ospedaliero Universitaria Ospedale Pediatrico MeyerCompleted
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La SapienzaCompleted
Roma, Italy
Juntendo University HospitalCompleted
Bunkyō City, Japan
Institute of Science Tokyo HospitalCompleted
Bunkyō City, Japan
Kokikai Tsujinaka Hospital KashiwanohaCompleted
Kashiwa-shi, Japan
Saga University HospitalCompleted
Saga, Japan
National Center for Child Health and DevelopmentCompleted
Setagaya-ku, Japan
Yokohama City University Medical Center, Center of IBDCompleted
Yokohama, Japan
Gabinet Lekarski Bartosz KorczowskiCompleted
Rzeszów, Poland
Twoja Przychodnia-Szczecińskie Centrum MedyczneCompleted
Szczecin, Poland
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor KierkusCompleted
Warsaw, Poland
Instytut 'Pomnik - Centrum Zdrowia DzieckaCompleted
Warsaw, Poland
Centrum Medyczne OporowCompleted
Wroclaw, Poland
Kyungpook National University Chilgok HospitalCompleted
Daegu, South Korea
Severance Hospital, Yonsei University Health SystemCompleted
Seoul, South Korea
Samsung Medical CenterCompleted
Seoul, South Korea
Sheffield Children's HospitalCompleted
Sheffield, United Kingdom
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis · TrialPath