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New hope for Crohn's: experimental drug targets gut inflammation

NCT ID NCT05910528

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Updated 2 times

Summary

This study tests an experimental drug called RO7790121 in about 21 adults with moderate to severe Crohn's disease who haven't responded well to other treatments. The goal is to see if the drug can reduce gut inflammation and improve symptoms like diarrhea and stomach pain. Participants receive either the drug or a placebo, and researchers monitor side effects and healing of the gut lining.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Dec 2026

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

18 to 75 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: * Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read * Elevated very soft or liquid stool frequency and/or abdominal pain * Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy Exclusion Criteria: * Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease * Short gut syndrome * Presence of an ostomy or ileoanal pouch * Bowel resection or diversion with \~6-months

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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.

Crohns disease

Contacts and locations

Locations

  • AZ Delta

    Roeselare, 8800, Belgium

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHRU de Nancy Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • CHU de Nantes

    Nantes, 44093, France

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047, United States

  • Digestive Health Specialists

    Dothan, Alabama, 36305, United States

  • I.H.S Health Northwell Health

    Kissimmee, Florida, 34741, United States

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200, France

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518, United States

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434, Poland

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728, Poland

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