NCT05509777RecruitingPhase 3
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 19 Aug 2022
- Start date
- 13 Mar 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Crohn's disease
- NCT number
- NCT05509777
- EU CT number
- 2024-511472-32-00
- EudraCT number
- 2022-000811-29
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 90
- From 13 Mar 2024 to the primary completion date, Dec 2027
- 85 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Other illness
- 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.
Other
- Participants must not have an abscess.
Who the study is looking for
- 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.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (85)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Hospital PUC-Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Hospital Pequeno Príncipe Coordinator of this site? Confirm its status | Curitiba-PR | Brazil | Recruiting |
| Hospital das Clínicas - UFG (Universidade Federal de Goiás) Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| NDI - Nucleo de Doenças Infecciosas Coordinator of this site? Confirm its status | Santos Dumont | Brazil | Recruiting |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Recruiting |
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| London Health Sciences Centre (LHSC) - Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Children's & Women's Health Centre of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Royal Hospital for Children and Young People Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Oxford University Hospitals NHS trust John Radcliffe hospital Coordinator of this site? Confirm its status | Headington | United Kingdom | Recruiting |
| Great Ormond Street Hospital For Children NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | Whitechapel | United Kingdom | Recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Recruiting |
| Shamir Medical Center (Assaf Harofeh) Coordinator of this site? Confirm its status | Israel | Israel | Recruiting |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Shaare Zedek Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Kaplan Medical Center, Pediatric Gastroenterology Dept. Coordinator of this site? Confirm its status | Rehovot | Israel | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Recruiting |
| Hirosaki University Hospital Coordinator of this site? Confirm its status | Hirosaki | Japan | Recruiting |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Kokikai Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Miyagi Children's Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Recruiting |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Not yet recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Saiseikai Yokohamashi Tobu Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Not yet recruiting |
| Yokohama City University Medical Center, Center of IBD Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lorenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Gabinet Lekarski Bartosz Korczowski Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Center for Digestive Health Care, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| Childrens Medical Center Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Riley Childrens Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Atlantic Children's Health--Pediatric Gastroenterology Coordinator of this site? Confirm its status | Morristown | United States | Not yet recruiting |
| Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Medical Center New York Presbyterian Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.