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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
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

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
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ViennaAustriaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Hospital PUC-Campinas
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CampinasBrazilRecruiting
Hospital Pequeno Príncipe
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Curitiba-PRBrazilRecruiting
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
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GoiâniaBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilRecruiting
NDI - Nucleo de Doenças Infecciosas
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Santos DumontBrazilRecruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilRecruiting
IWK Health Centre
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HalifaxCanadaRecruiting
London Health Sciences Centre (LHSC) - Victoria Hospital
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LondonCanadaRecruiting
The Hospital for Sick Children
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TorontoCanadaRecruiting
Children's & Women's Health Centre of British Columbia
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VancouverCanadaNot yet recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Royal Hospital for Children and Young People
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EdinburghUnited KingdomRecruiting
Oxford University Hospitals NHS trust John Radcliffe hospital
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HeadingtonUnited KingdomRecruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
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LondonUnited KingdomRecruiting
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomRecruiting
Royal London Hospital
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WhitechapelUnited KingdomRecruiting
Soroka Medical Center
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BeershebaIsraelRecruiting
Shamir Medical Center (Assaf Harofeh)
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IsraelIsraelRecruiting
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelRecruiting
Shaare Zedek
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JerusalemIsraelRecruiting
Schneider Children's Medical Center
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Petah TikvaIsraelRecruiting
Kaplan Medical Center, Pediatric Gastroenterology Dept.
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RehovotIsraelNot yet recruiting
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
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AlexandriaItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
ASST Fatebenefratelli Sacco
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MilanItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Hirosaki University Hospital
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HirosakiJapanRecruiting
Kagoshima University Hospital
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KagoshimaJapanRecruiting
Kokikai Tsujinaka Hospital Kashiwanoha
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Kashiwa-shiJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Miyagi Children's Hospital
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SendaiJapanRecruiting
National Center for Child Health and Development
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Setagaya-KuJapanRecruiting
Mie University Hospital
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TsuJapanNot yet recruiting
Yamaguchi University Hospital
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UbeJapanRecruiting
Saiseikai Yokohamashi Tobu Hospital
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YokohamaJapanNot yet recruiting
Yokohama City University Medical Center, Center of IBD
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YokohamaJapanRecruiting
Inje University Haeundae Paik Hospital
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BusanSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Akershus University Hospital
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LorenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Gabinet Lekarski Bartosz Korczowski
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RzeszówPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Centrum Medyczne Oporow
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WroclawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Children's Center for Digestive Health Care, LLC
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AtlantaUnited StatesRecruiting
Boston Children's Hospital
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BostonUnited StatesNot yet recruiting
University of Vermont Medical Center
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BurlingtonUnited StatesRecruiting
Childrens Medical Center
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DaytonUnited StatesRecruiting
Cook Children's Medical Center
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Fort WorthUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Riley Childrens Hospital
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IndianapolisUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesNot yet recruiting
Atlantic Children's Health--Pediatric Gastroenterology
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MorristownUnited StatesNot yet recruiting
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
Columbia University Medical Center New York Presbyterian
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New YorkUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.