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New hope for kids with Crohn's: drug trial targets remission

NCT ID NCT07298421

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This phase 3 trial tests a drug called afimkibart in 100 children aged 2-17 with moderate-to-severe Crohn's disease. The goal is to see if it can help children feel better and heal their intestines. Participants will receive the drug as an IV infusion or injection, and researchers will monitor safety and effectiveness over time.

What this could mean

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

Active substance
afimkibart (a drug given by IV infusion or injection)
What this could lead to
If it works, this could provide a new treatment option to help children with Crohn's disease achieve remission and heal their gut lining.
What could go wrong
This is still an experimental drug; it may not work better than existing treatments, and side effects are possible. The trial is relatively small (100 children), so results may not apply to everyone.

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

Aug 2026

Expected to finish

May 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: * Body weight \>= 10 kilogram (kg) * Active CD confirmed by endoscopy (ileocolonoscopy) * Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy * Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors) Exclusion Criteria: * Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD) * History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum * Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease. * Symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Current diagnosis or suspicion of primary sclerosing cholangitis

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Moderately to severely active crohns disease

How to take part

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

  1. The places running it

    14 sites in 8 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

  • BR Trials - Pesquisa Clínica

    RECRUITING

    São Paulo, São Paulo, 01236-030, Brazil

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    RECRUITING

    Jaú, São Paulo, 17201-130, Brazil

  • Centro de Investigación Clínica Acelerada, S.C

    RECRUITING

    Mexico City, Mexico CITY (federal District), 07369, Mexico

  • Chulalongkorn University

    RECRUITING

    Bangkok, 10330, Thailand

  • Emmed Research

    RECRUITING

    Pretoria, Gauteng, 84, South Africa

  • FAICIC Clinical Research

    RECRUITING

    Veracruz, 91900, Mexico

  • IATROS International

    RECRUITING

    Bloemfontein, 9301, South Africa

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ramathibodi Hospital

    RECRUITING

    Bangkok, Thailand

  • Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Sheffield Childrens Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

More trials for these conditions

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