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New drug shows promise for kids with severe bowel disease

NCT ID NCT05784246

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug mirikizumab in 63 children aged 2 to 17 with moderate-to-severe ulcerative colitis, a chronic bowel disease. The goal was to see if the drug could help control the disease and improve symptoms. All children received the drug, and researchers measured remission rates after one year.

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 ulcerative colitis who have not responded to other therapies.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. The drug may not work as well in children as in adults, and side effects are possible.

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

63 people

The number who actually took part.

Started

Nov 2023

Finished

May 2026

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: * Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening. * Have moderate to severe UC. * Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment. * Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report. Exclusion Criteria: * Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis. * Have immune deficiency syndrome. * Previous bowel resection or intestinal surgery. * Evidence of toxic megacolon. * History or current evidence of cancer of the gastrointestinal tract.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161, Italy

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, 50139, Italy

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia, 30342, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, 35-302, Poland

  • Hadassah University Hospital, Ein Kerem

    Jerusalem, 911200, Israel

  • Helios Klinikum Wuppertal

    Wuppertal, 42283, Germany

  • Hôpital Necker - Enfants Malades

    Paris, 75015, France

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113-8519, Japan

  • Instytut 'Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • King Fahad Medical City

    Rishon LeZiyyon, 70300, Israel

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, 277-0871, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • LMU-Campus Innenstadt

    München, 80337, Germany

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

    Warsaw, 04-501, Poland

  • National Center for Child Health and Development

    Setagaya-ku, 157-8535, Japan

  • Riley Childrens Hospital

    Indianapolis, Indiana, 46202, United States

  • Saga University Hospital

    Saga, 849-8501, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek

    Jerusalem, 9103102, Israel

  • Sheffield Children's Hospital

    Sheffield, S102TH, United Kingdom

  • The Hospital for Sick Children

    Toronto, M5G 0A4, Canada

  • Twoja Przychodnia-Szczecińskie Centrum Medyczne

    Szczecin, 71-434, Poland

  • UZ Leuven

    Leuven, 3000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131, Germany

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • Washington University

    St Louis, Missouri, 63110-1010, United States

  • Yokohama City University Medical Center, Center of IBD

    Yokohama, 232-0024, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.