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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
NCT05509777 · Eli Lilly and Company
In plain English
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Official title
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
About this study
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
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.
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: child
Timeline
Starts: 2024-03-13
Estimated completion: 2028-04
Last updated: 2026-03-27
Interventions
Drug: Mirikizumab
Primary outcomes
- • Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (Baseline to Week 52)
- • Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 (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 (81)
Cedars Sinai Medical CenterNot Yet Recruiting
Los Angeles, California, United States
Connecticut Children's Medical CenterRecruiting
Hartford, Connecticut, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLCRecruiting
Atlanta, Georgia, United States
Riley Childrens HospitalRecruiting
Indianapolis, Indiana, United States
Boston Children's HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Atlantic Children's Health--Pediatric GastroenterologyNot Yet Recruiting
Morristown, New Jersey, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)Recruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Columbia University Medical Center/New York PresbyterianRecruiting
New York, New York, United States
Childrens Medical CenterRecruiting
Dayton, Ohio, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
Seattle Children's HospitalNot Yet Recruiting
Seattle, Washington, United States
AKH - Medizinische Universtität WienRecruiting
Vienna, Austria
Universitair Ziekenhuis BrusselRecruiting
Brussels, Belgium
Cliniques universitaires Saint-LucRecruiting
Brussels, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
Hospital PUC-CAMPINASRecruiting
Campinas, Brazil
Hospital Pequeno PríncipeRecruiting
Curitiba-PR, Brazil
Hospital das Clínicas - UFG (Universidade Federal de Goiás)Recruiting
Goiânia, Brazil
Hospital de Clínicas de Porto AlegreRecruiting
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto AlegreRecruiting
Porto Alegre, Brazil
NDI - Nucleo de Doenças InfecciosasRecruiting
Santos Dumont, Brazil
Integral Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
IWK Health CentreNot Yet Recruiting
Halifax, Canada
London Health Sciences Centre (LHSC) - Victoria HospitalNot Yet Recruiting
London, Canada
The Hospital for Sick ChildrenNot Yet Recruiting
Toronto, Canada
Children's & Women's Health Centre of British ColumbiaNot Yet Recruiting
Vancouver, Canada
URC CICTerminated
Paris, France
Soroka Medical CenterRecruiting
Beersheba, Israel
Shamir Medical Center (Assaf Harofeh)Recruiting
Israel, Israel
Shaare ZedekRecruiting
Jerusalem, Israel
Hadassah University Hospital, Ein Kerem,Recruiting
Jerusalem, Israel
Schneider Children's Medical CenterRecruiting
Petah Tikva, Israel
Kaplan Medical Center, Pediatric Gastroenterology Dept.Not Yet Recruiting
Rehovot, Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. ArrigoNot Yet Recruiting
Alessandria, Italy
Asst Papa Giovanni Xxiii BergamoRecruiting
Bergamo, Italy
Azienda USL di BolognaRecruiting
Bologna, Italy
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)Recruiting
Florence, Italy
Ospedale dei Bambini Vittore BuzziRecruiting
Milan, Italy
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)Recruiting
Roma, Italy
Juntendo University HospitalRecruiting
Bunkyō City, Japan
Hirosaki University HospitalRecruiting
Hirosaki, Japan
Kagoshima University HospitalNot Yet Recruiting
Kagoshima, Japan
Kokikai Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa-shi, Japan
Kobe University HospitalNot Yet Recruiting
Kobe, Japan
Saga University HospitalRecruiting
Saga, Japan
Miyagi Children's HospitalRecruiting
Sendai, Japan
National Center for Child Health and DevelopmentRecruiting
Setagaya-ku, Japan
Mie University HospitalNot Yet Recruiting
Tsu, Japan
Yamaguchi University HospitalNot Yet Recruiting
Ube, Japan
Saiseikai Yokohamashi Tobu HospitalNot Yet Recruiting
Yokohama, Japan
Yokohama City University Medical Center, Center of IBDRecruiting
Yokohama, Japan
Erasmus Medisch CentrumRecruiting
Rotterdam, Netherlands
Akershus UniversitetssykehusRecruiting
Nordbyagen, Norway
Oslo University HospitalRecruiting
Oslo, Norway
Universitetssykehuset Nord-NorgeRecruiting
Tromsø, Norway
St-Olavs HospitalRecruiting
Trondheim, Norway
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Instytut Pomnik-Centrum Zdrowia DzieckaRecruiting
Warsaw, Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)Recruiting
Braga, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa MariaRecruiting
Lisbon, Portugal
Centro Hospitalar de São João, E.P.E.Recruiting
Porto, Portugal
Inje University Haeundae Paik HospitalRecruiting
Busan, South Korea
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
Corporacio Sanitaria Parc TauliRecruiting
Sabadell, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Royal Hospital for Children and Young PeopleRecruiting
Edinburgh, United Kingdom
Oxford University Hospitals NHS trust John Radcliffe hospitalRecruiting
Headington, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation TrustRecruiting
London, United Kingdom
Manchester University NHS Foundation TrustRecruiting
Manchester, United Kingdom
Sheffield Children's HospitalRecruiting
Sheffield, United Kingdom
Royal London HospitalRecruiting
Whitechapel, United Kingdom