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

NCT ID NCT05509777

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 4 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    80 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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