A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Recruiting · NCT05509777 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 12 US states.
- 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
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo - Alessandria, Italy
- Soroka Medical Center - Beersheba, Israel
- Asst Papa Giovanni Xxiii Bergamo - Bergamo, Italy
- Azienda USL di Bologna - Bologna, Italy
- Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga) - Braga, Portugal
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Cliniques universitaires Saint-Luc - Brussels, Belgium
- Juntendo University Hospital - Bunkyō City, Japan
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Hospital PUC-CAMPINAS - Campinas, Brazil
- Hospital Pequeno Príncipe - Curitiba-PR, Brazil
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Royal Hospital for Children and Young People - Edinburgh, United Kingdom
- SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato) - Florence, Italy
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Hospital das Clínicas - UFG (Universidade Federal de Goiás) - Goiânia, Brazil
- IWK Health Centre - Halifax, Canada
- Oxford University Hospitals NHS trust John Radcliffe hospital - Headington, United Kingdom
- Hirosaki University Hospital - Hirosaki, Japan
- Shamir Medical Center (Assaf Harofeh) - Israel, Israel
- Shaare Zedek - Jerusalem, Israel
- Hadassah University Hospital, Ein Kerem, - Jerusalem, Israel
- Kagoshima University Hospital - Kagoshima, Japan
- Kokikai Tsujinaka Hospital Kashiwanoha - Kashiwa-shi, Japan
- Kobe University Hospital - Kobe, Japan
- UZ Leuven - Leuven, Belgium
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria - Lisbon, Portugal
- London Health Sciences Centre (LHSC) - Victoria Hospital - London, Canada
- Great Ormond Street Hospital For Children NHS Foundation Trust - London, United Kingdom
- Manchester University NHS Foundation Trust - Manchester, United Kingdom
- Ospedale dei Bambini Vittore Buzzi - Milan, Italy
- Akershus Universitetssykehus - Nordbyagen, Norway
- Oslo University Hospital - Oslo, Norway
- URC CIC - Paris, France
- Schneider Children's Medical Center - Petah Tikva, Israel
- Centro Hospitalar de São João, E.P.E. - Porto, Portugal
- Hospital de Clínicas de Porto Alegre - Porto Alegre, Brazil
- Irmandade da Santa Casa de Misericórdia de Porto Alegre - Porto Alegre, Brazil
- Kaplan Medical Center, Pediatric Gastroenterology Dept. - Rehovot, Israel
- Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica) - Roma, Italy
- Erasmus Medisch Centrum - Rotterdam, Netherlands
- Korczowski Bartosz, Gabinet Lekarski - Rzeszów, Poland
- Corporacio Sanitaria Parc Tauli - Sabadell, Spain
- Saga University Hospital - Saga, Japan
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →