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New hope for kids with severe gut disease: drug trial launches

NCT ID NCT07158242

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This study tests a new medicine called afimkibart in children aged 2 to 17 with moderate to severe ulcerative colitis, a disease that causes inflammation and sores in the colon. The goal is to see if the drug can safely help children feel better and achieve remission (no symptoms) at 12 and 52 weeks. About 100 children who have not responded well to other treatments will take part.

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 100 people

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

Started

Apr 2026

Expected to finish

Mar 2031

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: * Bodyweight \>= 10 kilogram (kg) * Confirmed diagnosis of UC * Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy) * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol Exclusion Criteria: * Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) * Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

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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.

Moderately to severely active ulcerative colitis

How to take part

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

  1. The places running it

    22 sites in 9 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

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • BR Trials - Pesquisa Clínica

    RECRUITING

    São Paulo, São Paulo, 03325-050, Brazil

  • Birmingham Children's Hospital

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    RECRUITING

    Jaú, São Paulo, 17201-130, Brazil

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital ZheJiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310052, China

  • Chulalongkorn University

    RECRUITING

    Bangkok, 10330, Thailand

  • Emmed Research

    RECRUITING

    Pretoria, 0002, South Africa

  • Hospital For Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • IATROS International

    RECRUITING

    Bloemfontein, 9301, South Africa

  • Mater Hospital Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Northwell Health

    RECRUITING

    Lake Success, New York, 11042, United States

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ramathibodi Hospital

    RECRUITING

    Bangkok, Thailand

  • Royal Childrens Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, 200025, China

  • Sheffield Childrens Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

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