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New hope for kids with IBD: Long-Term drug trial launches

NCT ID NCT04844606

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests the long-term safety and effectiveness of mirikizumab in 150 children and adolescents with moderate-to-severe ulcerative colitis or Crohn's disease. Participants who completed earlier mirikizumab studies can join. The trial lasts about 172 weeks and aims to see if the drug can keep the disease under control.

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 long-term treatment option to control moderate-to-severe ulcerative colitis or Crohn's disease in children and adolescents.
What could go wrong
This is an extension study, so participants already benefited from mirikizumab in prior trials. It is open-label (no placebo), which can bias results. Long-term safety and effectiveness are still being confirmed.

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 150 people

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

Started

May 2021

Expected to finish

Dec 2030

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 19 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 from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. * Female participants must agree to contraception requirements. Exclusion Criteria: * Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. * Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. * Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. * Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. * Participants must not have adenomatous polyps that have not been removed. * Participants must not be pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease Pediatric Crohn's disease Pediatric ulcerative colitis ulcerative colitis

As listed by the trial registrant

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

Crohn's disease Inflammatory bowel diseases Ulcerative colitis Ulcerative colitis chronic

How to take part

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

  1. The places running it

    68 sites in 16 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

  • 2Ca Braga

    NOT_YET_RECRUITING

    Braga, 4710-243, Portugal

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • Akershus Universitetssykehus

    NOT_YET_RECRUITING

    Lørenskog, 1478, Norway

  • Antwerp University Hospital

    NOT_YET_RECRUITING

    Edegem, 2650, Belgium

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    RECRUITING

    Florence, 50139, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Centro Hospitalar de Sao Joao - Hospital de Sao Joao

    RECRUITING

    Porto, 4200-319, Portugal

  • Centro de Pesquisa Sao Lucas

    NOT_YET_RECRUITING

    Campinas, 13060-803, Brazil

  • Centrum Medyczne Oporów

    RECRUITING

    Wroclaw, 52-416, Poland

  • Centrum Zdrowia Dziecka w Warszawie

    RECRUITING

    Warsaw, 04-730, Poland

  • Children's Center for Digestive Health Care, LLC

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Philadelphia (CHOP)

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cliniques universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, 1200, Belgium

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Dr. von Haunersches Kinderspital

    RECRUITING

    Munich, 80337, Germany

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erasmus Medisch Centrum

    NOT_YET_RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    NOT_YET_RECRUITING

    Curitiba, 80250-060, Brazil

  • Hospital Sant Joan de Déu

    NOT_YET_RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitari Parc Tauli

    NOT_YET_RECRUITING

    Sabadell, 08208, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Cassiano Antonio de Moraes

    NOT_YET_RECRUITING

    Vitória, 29040-091, Brazil

  • Hospital Universitario Reina Sofia

    NOT_YET_RECRUITING

    Córdoba, 14004, Spain

  • Hospital de Clinicas de Porto Alegre

    NOT_YET_RECRUITING

    Porto Alegre, 90035-903, Brazil

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyō, 113-8519, Japan

  • Integral Pesquisa e Ensino

    NOT_YET_RECRUITING

    Votuporanga, 15500-269, Brazil

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    NOT_YET_RECRUITING

    Porto Alegre, 90050-170, Brazil

  • Juntendo University Hospital

    RECRUITING

    Bunkyō City, 113-8431, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, 650-0017, Japan

  • Korczowski Bartosz, Gabinet Lekarski

    RECRUITING

    Rzeszów, 35-302, Poland

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Deagu, 41404, South Korea

  • London Health Sciences Centre

    NOT_YET_RECRUITING

    London, N6A 5W9, Canada

  • Massachusetts General Hospital

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    RECRUITING

    Warsaw, 04-501, Poland

  • Medizinische Universität Wien

    NOT_YET_RECRUITING

    Vienna, 1090, Austria

  • National Center for Child Health and Development

    RECRUITING

    Tokyo, 157-8535, Japan

  • Oslo Universitetssykehus Ullevål

    NOT_YET_RECRUITING

    Oslo, 0450, Norway

  • Ospedale Maggiore Azienda USL di Bologna

    NOT_YET_RECRUITING

    Bologna, 40133, Italy

  • Ospedale Pediatrico Bambino Gesù IRCCS

    NOT_YET_RECRUITING

    Rome, 00165, Italy

  • Ospedale dei Bambini Vittore Buzzi

    RECRUITING

    Milan, 20154, Italy

  • Pediatric Specialists of Virginia

    NOT_YET_RECRUITING

    Fairfax, Virginia, 22031, United States

  • Rambam Health Care Campus

    NOT_YET_RECRUITING

    Haifa, 3109601, Israel

  • Royal London Hospital

    NOT_YET_RECRUITING

    London, E1 1BB, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Schneider Children's Medical Center

    RECRUITING

    Petah Tikva, 49202, Israel

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9013102, Israel

  • Sheffield Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Soroka Medical Center

    NOT_YET_RECRUITING

    Beersheba, 8410101, Israel

  • St. Olavs Hospital

    NOT_YET_RECRUITING

    Trondheim, 7030, Norway

  • The Hospital for Sick Children

    RECRUITING

    Toronto, M5G 1X8, Canada

  • The John Radcliffe Hospital

    NOT_YET_RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Tsujinaka Hospital - Kashiwanoha

    RECRUITING

    Kashiwa, 273-0011, Japan

  • Twoja Przychodnia SCM

    RECRUITING

    Szczecin, 71-434, Poland

  • UCSF Medical Center at Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

  • UZ Brussel

    NOT_YET_RECRUITING

    Brussels, 1090, Belgium

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universidade Federal de Goias

    NOT_YET_RECRUITING

    Goiânia, 74605-020, Brazil

  • Universitetssykehuset Nord-Norge HF

    NOT_YET_RECRUITING

    Tromsø, 9038, Norway

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yitzhak Shamir Medical Center

    RECRUITING

    Ẕerifin, 70300, Israel

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, 232-0024, Japan

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