New drug hope for kids with Crohn's: mirikizumab enters final testing

NCT ID NCT05509777

Recruiting now Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This phase 3 trial tests mirikizumab, an injected drug, in 90 children with moderate-to-severe Crohn's disease. The study looks at whether the drug can improve symptoms and heal the gut lining over 52 weeks. Participants receive mirikizumab during a 12-week induction period, then continue into a maintenance phase.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: mirikizumab
What this could lead to: If successful, this could provide a new treatment option for children with moderate-to-severe Crohn's disease, helping control symptoms and reduce gut inflammation.
What could go wrong: This is still an experimental drug; it may not work better than existing treatments, and side effects like infections or allergic reactions are possible. The trial is also relatively small (90 participants).

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CROHN'S DISEASE

Contacts and locations

Locations

AKH - Medizinische Universtität Wien
RECRUITING

Vienna, 1090, Austria
Akershus Universitetssykehus
RECRUITING

Nordbyagen, 01474, Norway
Asst Papa Giovanni Xxiii Bergamo
RECRUITING

Bergamo, 24127, Italy
Atlantic Children's Health--Pediatric Gastroenterology
NOT_YET_RECRUITING

Morristown, New Jersey, 07960, United States
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
NOT_YET_RECRUITING

Alessandria, 15121, Italy
Azienda USL di Bologna
RECRUITING

Bologna, 40133, Italy
Boston Children's Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02115, United States
Cedars Sinai Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
RECRUITING

Braga, 4710-243, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
RECRUITING

Lisbon, 1649-035, Portugal
Centro Hospitalar de São João, E.P.E.
RECRUITING

Porto, 4200 319, Portugal
Children's & Women's Health Centre of British Columbia
NOT_YET_RECRUITING

Vancouver, V6H 3V4, Canada
Children's Center for Digestive Health Care, LLC
RECRUITING

Atlanta, Georgia, 30342, United States
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19146, United States
Childrens Medical Center
RECRUITING

Dayton, Ohio, 45404, United States
Cliniques universitaires Saint-Luc
RECRUITING

Brussels, 1200, Belgium
Columbia University Medical Center/New York Presbyterian
RECRUITING

New York, New York, 10032, United States
Connecticut Children's Medical Center
RECRUITING

Hartford, Connecticut, 06032, United States
Cook Children's Medical Center
RECRUITING

Fort Worth, Texas, 76104, United States
Corporacio Sanitaria Parc Tauli
RECRUITING

Sabadell, 08208, Spain
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Erasmus Medisch Centrum
RECRUITING

Rotterdam, 3015 CN, Netherlands
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
RECRUITING

Roma, CAP 00161, Italy
Great Ormond Street Hospital For Children NHS Foundation Trust
RECRUITING

London, WC1N 3JH, United Kingdom
Hadassah University Hospital, Ein Kerem,
RECRUITING

Jerusalem, 9112001, Israel
Hirosaki University Hospital
RECRUITING

Hirosaki, 036, Japan
Hospital PUC-CAMPINAS
RECRUITING

Campinas, 13060-904, Brazil
Hospital Pequeno Príncipe
RECRUITING

Curitiba-PR, 80250-060, Brazil
Hospital Universitari i Politecnic La Fe
RECRUITING

Valencia, 46026, Spain
Hospital Universitario Reina Sofia
RECRUITING

Córdoba, 14004, Spain
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
RECRUITING

Goiânia, 74605-050, Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING

Porto Alegre, 90035-903, Brazil
IWK Health Centre
RECRUITING

Halifax, B3K 6R8, Canada
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Inje University Haeundae Paik Hospital
RECRUITING

Busan, 48108, South Korea
Instytut Pomnik-Centrum Zdrowia Dziecka
RECRUITING

Warsaw, 04-730, Poland
Integral Pesquisa e Ensino
RECRUITING

Votuporanga, 15501 405, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING

Porto Alegre, 90050-170, Brazil
Juntendo University Hospital
RECRUITING

Bunkyō City, 113-8431, Japan
Kagoshima University Hospital
RECRUITING

Kagoshima, 890-8520, Japan
Kaplan Medical Center, Pediatric Gastroenterology Dept.
NOT_YET_RECRUITING

Rehovot, 7661041, Israel
Kobe University Hospital
RECRUITING

Kobe, 650-0017, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
RECRUITING

Kashiwa-shi, 277-0871, Japan
Korczowski Bartosz, Gabinet Lekarski
RECRUITING

Rzeszów, 35-302, Poland
Kyungpook National University Chilgok Hospital
RECRUITING

Daegu, 41404, South Korea
London Health Sciences Centre (LHSC) - Victoria Hospital
RECRUITING

London, N6A 5W9, Canada
Manchester University NHS Foundation Trust
RECRUITING

Manchester, M139WL, United Kingdom
Mie University Hospital
NOT_YET_RECRUITING

Tsu, 514-8507, Japan
Miyagi Children's Hospital
RECRUITING

Sendai, 989 3126, Japan
NDI - Nucleo de Doenças Infecciosas
RECRUITING

Santos Dumont, 29040-091, Brazil
National Center for Child Health and Development
RECRUITING

Setagaya-ku, 157-8535, Japan
Oslo University Hospital
RECRUITING

Oslo, 0450, Norway
Ospedale dei Bambini Vittore Buzzi
RECRUITING

Milan, 20154, Italy
Oxford University Hospitals NHS trust John Radcliffe hospital
RECRUITING

Headington, OX3 9DU, United Kingdom
Riley Childrens Hospital
RECRUITING

Indianapolis, Indiana, 46202, United States
Royal Hospital for Children and Young People
RECRUITING

Edinburgh, EH16 4TJ, United Kingdom
Royal London Hospital
RECRUITING

Whitechapel, E1 1FR, United Kingdom
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
RECRUITING

Florence, 50139, Italy
Saga University Hospital
RECRUITING

Saga, 849-8501, Japan
Saiseikai Yokohamashi Tobu Hospital
NOT_YET_RECRUITING

Yokohama, 2308765, Japan
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Schneider Children's Medical Center
RECRUITING

Petah Tikva, 4920235, Israel
Seattle Children's Hospital
NOT_YET_RECRUITING

Seattle, Washington, 98105, United States
Seoul National University Hospital
RECRUITING

Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Shaare Zedek
RECRUITING

Jerusalem, 9103102, Israel
Shamir Medical Center (Assaf Harofeh)
RECRUITING

Israel, 70300, Israel
Sheffield Children's Hospital
RECRUITING

Sheffield, S10 2RX, United Kingdom
Soroka Medical Center
RECRUITING

Beersheba, 8410101, Israel
St-Olavs Hospital
RECRUITING

Trondheim, 7030, Norway
The Hospital for Sick Children
RECRUITING

Toronto, M5G 1X8, Canada
URC CIC
TERMINATED

Paris, 75015, France
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
Universitair Ziekenhuis Brussel
RECRUITING

Brussels, 1090, Belgium
Universitair Ziekenhuis Gent
RECRUITING

Ghent, 9000, Belgium
Universitetssykehuset Nord-Norge
RECRUITING

Tromsø, 9038, Norway
University of Vermont Medical Center
RECRUITING

Burlington, Vermont, 05401, United States
Warsaw IBD Point Profesor Kierkus
RECRUITING

Warsaw, 00-728, Poland
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
RECRUITING

New York, New York, 10021-5663, United States
Yamaguchi University Hospital
RECRUITING

Ube, 755-8505, Japan
Yokohama City University Medical Center, Center of IBD
RECRUITING

Yokohama, 232-0024, Japan

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