N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT05509777

Registry updated: 2026-10-07
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

Interventions

  • Mirikizumab (Drug)
    Administered IV or SC

Eligibility criteria

Inclusion Criteria: * Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30). * Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0. * Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor. Exclusion Criteria: * Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery. * Participants must not have an abscess. * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Conditions

Crohn's Disease

Locations

  • Cedars Sinai Medical Center — Los Angeles, California, United States
  • Connecticut Children's Medical Center — Hartford, Connecticut, United States
  • Emory University — Atlanta, Georgia, United States
  • Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States
  • Riley Childrens Hospital — Indianapolis, Indiana, United States
  • Boston Children's Hospital — Boston, Massachusetts, United States
  • Atlantic Children's Health--Pediatric Gastroenterology — Morristown, New Jersey, United States
  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Columbia University Medical Center/New York Presbyterian — New York, New York, United States
  • Childrens Medical Center — Dayton, Ohio, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Cook Children's Medical Center — Fort Worth, Texas, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • Seattle Children's Hospital — Seattle, Washington, United States
  • AKH - Medizinische Universtität Wien — Vienna, Austria
  • Universitair Ziekenhuis Brussel — Brussels, Belgium
  • Cliniques universitaires Saint-Luc — Brussels, Belgium
  • Universitair Ziekenhuis Gent — Ghent, Belgium
  • UZ Leuven — Leuven, Belgium
  • Hospital PUC-CAMPINAS — Campinas, Brazil
  • Hospital Pequeno Príncipe — Curitiba-PR, Brazil
  • Hospital das Clínicas - UFG (Universidade Federal de Goiás) — Goiânia, Brazil
  • Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil
  • NDI - Nucleo de Doenças Infecciosas — Santos Dumont, Brazil
  • Integral Pesquisa e Ensino — Votuporanga, Brazil
  • IWK Health Centre — Halifax, Canada
  • London Health Sciences Centre (LHSC) - Victoria Hospital — London, Canada
  • The Hospital for Sick Children — Toronto, Canada
  • Children's & Women's Health Centre of British Columbia — Vancouver, Canada
  • URC CIC — Paris, France
  • Soroka Medical Center — Beersheba, Israel
  • Shamir Medical Center (Assaf Harofeh) — Israel, Israel
  • Shaare Zedek — Jerusalem, Israel
  • Hadassah University Hospital, Ein Kerem, — Jerusalem, Israel
  • Schneider Children's Medical Center — Petah Tikva, Israel
  • Kaplan Medical Center, Pediatric Gastroenterology Dept. — Rehovot, Israel
  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo — Alessandria, Italy
  • Asst Papa Giovanni Xxiii Bergamo — Bergamo, Italy
  • Azienda USL di Bologna — Bologna, Italy
  • SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato) — Florence, Italy
  • Ospedale dei Bambini Vittore Buzzi — Milan, Italy
  • Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica) — Roma, Italy
  • Juntendo University Hospital — Bunkyō City, Japan
  • Hirosaki University Hospital — Hirosaki, Japan
  • Kagoshima University Hospital — Kagoshima, Japan
  • Kokikai Tsujinaka Hospital Kashiwanoha — Kashiwa-shi, Japan
  • Kobe University Hospital — Kobe, Japan
  • Saga University Hospital — Saga, Japan
  • Miyagi Children's Hospital — Sendai, Japan
  • National Center for Child Health and Development — Setagaya-ku, Japan
  • Mie University Hospital — Tsu, Japan
  • Yamaguchi University Hospital — Ube, Japan
  • Saiseikai Yokohamashi Tobu Hospital — Yokohama, Japan
  • Yokohama City University Medical Center, Center of IBD — Yokohama, Japan
  • Erasmus Medisch Centrum — Rotterdam, Netherlands
  • Akershus Universitetssykehus — Nordbyagen, Norway
  • Oslo University Hospital — Oslo, Norway
  • Universitetssykehuset Nord-Norge — Tromsø, Norway
  • St-Olavs Hospital — Trondheim, Norway
  • Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland
  • Warsaw IBD Point Profesor Kierkus — Warsaw, Poland
  • Instytut Pomnik-Centrum Zdrowia Dziecka — Warsaw, Poland
  • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga) — Braga, Portugal
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria — Lisbon, Portugal
  • Centro Hospitalar de São João, E.P.E. — Porto, Portugal
  • Inje University Haeundae Paik Hospital — Busan, South Korea
  • Kyungpook National University Chilgok Hospital — Daegu, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Hospital Universitario Reina Sofia — Córdoba, Spain
  • Corporacio Sanitaria Parc Tauli — Sabadell, Spain
  • Hospital Universitari i Politecnic La Fe — Valencia, Spain
  • Royal Hospital for Children and Young People — Edinburgh, United Kingdom
  • Oxford University Hospitals NHS trust John Radcliffe hospital — Headington, United Kingdom
  • Great Ormond Street Hospital For Children NHS Foundation Trust — London, United Kingdom
  • Manchester University NHS Foundation Trust — Manchester, United Kingdom
  • Sheffield Children's Hospital — Sheffield, United Kingdom
  • Royal London Hospital — Whitechapel, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record