Clinical trialNCT05509777RecruitingPhase 3Interventional

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

SponsorEli Lilly and CompanyEnrollment90Crohn's Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Call 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)
Eli Lilly and Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

81 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria

Akh - Medizinische Universtität Wien
Vienna, Austria
Judith Pichler
Recruiting

Belgium

Cliniques Universitaires Saint-Luc
Brussels, Belgium
Francoise Smets
Recruiting
Universitair Ziekenhuis Brussel
Brussels, Belgium
Elisabeth De Greef
Recruiting
Universitair Ziekenhuis Gent
Ghent, Belgium
Pauline De Bruyne
Recruiting
Uz Leuven
Leuven, Belgium
Ilse Hoffman
Recruiting

Brazil

Hospital Puc-Campinas
Campinas, Brazil
Joaquim Simoes Neto
Recruiting
Hospital Pequeno Príncipe
Curitiba-PR, Brazil
Sabine Krüger Truppel
Recruiting
Hospital Das Clínicas - Ufg (universidade Federal de Goiás)
Goiânia, Brazil
Naflesia Oliveira Correa
Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Luciana Harlacher
Recruiting
Irmandade Da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Cristina Ferreira
Recruiting
Ndi - Nucleo de Doenças Infecciosas
Santos Dumont, Brazil
Ana Daniela Izoton de Sadovsky
Recruiting
Integral Pesquisa E Ensino
Votuporanga, Brazil
Herlon Valerio
Recruiting

Canada

Iwk Health Centre
Halifax, Canada
Anthony Otley
Recruiting
London Health Sciences Centre (lhsc) - Victoria Hospital
London, Canada
Dhandapani Ashok
Recruiting
the Hospital for Sick Children
Toronto, Canada
Thomas Walters
Recruiting
Children'S & Women'S Health Centre of British Columbia
Vancouver, Canada
Kevan Jacobson
Not, yet, recruiting

France

Urc Cic
Paris, France
Terminated

Israel

Soroka Medical Center
Beersheba, Israel
Baruch Yerushalmi
Recruiting
Shamir Medical Center (assaf Harofeh)
Israel, Israel
EFRAT BROIDE
Recruiting
Hadassah University Hospital, Ein Kerem,
Jerusalem, Israel
Zev Davidovics
Recruiting
Shaare Zedek
Jerusalem, Israel
Dan Turner
Recruiting
Schneider Children'S Medical Center
Petah Tikva, Israel
Dror Shouval
Recruiting
Kaplan Medical Center, Pediatric Gastroenterology Dept.
Rehovot, Israel
Amit Assa
Not, yet, recruiting

Italy

Azienda Ospedaliero-Universitaria Ss. Antonio E Biagio E C. Arrigo
Alessandria, Italy
Felici Enrico
Not, yet, recruiting
Asst Papa Giovanni Xxiii Bergamo
Bergamo, Italy
Naire Sansotta
Recruiting
Azienda Usl Di Bologna
Bologna, Italy
Patrizia Alvisi
Recruiting
Soc Gastroenterologia E Nutrizione - Aou Meyer (primo Piano Ala Ovest, Accettazione Dh Centralizzato)
Florence, Italy
Paolo Lionetti
Recruiting
Ospedale Dei Bambini Vittore Buzzi
Milan, Italy
Lorenzo Norsa
Recruiting
Gastroenterologia Ed Epatologia Pediatrica (piano Terra Della Clinica Pediatrica)
Roma, Italy
Salvatore Oliva
Recruiting

Japan

Juntendo University Hospital
Bunkyō City, Japan
Takahiro Kudo
Recruiting
Hirosaki University Hospital
Hirosaki, Japan
Hirotake Sakuraba
Recruiting
Kagoshima University Hospital
Kagoshima, Japan
Takuro Nishikawa
Recruiting
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan
Ken Takeuchi
Recruiting
Kobe University Hospital
Kobe, Japan
Tomoko Horinouchi
Recruiting
Saga University Hospital
Saga, Japan
Toshihiko Kakiuchi
Recruiting
Miyagi Children'S Hospital
Sendai, Japan
Daiki Abukawa
Recruiting
National Center for Child Health and Development
Setagaya-ku, Japan
Katsuhiro Arai
Recruiting
Mie University Hospital
Tsu, Japan
Yuki Koike
Not, yet, recruiting
Yamaguchi University Hospital
Ube, Japan
Azuma Yoshihiro
Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan
Shuichiro Umetsu
Not, yet, recruiting

41 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Mirikizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 13 Mar 2024
Primary completion: 31 Dec 2027
Completion: 30 Apr 2028
Last update posted: 7 Aug 2026
Registered enrollment: 90
Registry id: NCT05509777

Cross-registrations

EU-CTR / CTIS (EudraCT)2024-511472-32-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.