RecruitingPhase 3NCT05784246

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

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

Sponsor

Eli Lilly and Company

Enrollment

60 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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).

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mirikizumab — a drug that targets a protein involved in gut inflammation — in children and teenagers with moderate-to-severe ulcerative colitis (UC). UC is a chronic inflammatory bowel disease that causes ulcers and inflammation in the large intestine. **You may be eligible if:** - You are between 2 and 17 years old and weigh at least 10 kg - You have moderate-to-severe ulcerative colitis confirmed by colonoscopy and biopsy, with symptoms lasting at least 3 months - Your UC has not responded adequately to corticosteroids, biologic medications (such as anti-TNF or anti-integrin drugs), immunosuppressants (like azathioprine or methotrexate), or JAK inhibitors **You may NOT be eligible if:** - You have Crohn's disease or another form of inflammatory bowel disease - You are under 2 years old or 18 and older - You have not tried other treatments first Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirikizumab IV

Administered IV

DRUGMirikizumab SC

Administered SC

Locations(34)

University of California, San Francisco

San Francisco, California, United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Riley Childrens Hospital

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

UZA

Edegem, Belgium

UZ Leuven

Leuven, Belgium

The Hospital for Sick Children

Toronto, Canada

Hôpital Necker - Enfants Malades

Paris, France

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

LMU-Campus Innenstadt

München, Germany

Helios Klinikum Wuppertal

Wuppertal, Germany

Shaare Zedek

Jerusalem, Israel

Hadassah University Hospital, Ein Kerem

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

King Fahad Medical City

Rishon LeZiyyon, Israel

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

Florence, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Roma, Italy

Juntendo University Hospital

Bunkyō City, Japan

Institute of Science Tokyo Hospital

Bunkyō City, Japan

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Japan

Saga University Hospital

Saga, Japan

National Center for Child Health and Development

Setagaya-ku, Japan

Yokohama City University Medical Center, Center of IBD

Yokohama, Japan

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland

Twoja Przychodnia-Szczecińskie Centrum Medyczne

Szczecin, Poland

Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Instytut 'Pomnik - Centrum Zdrowia Dziecka

Warsaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Sheffield Children's Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05784246

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