Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can mirikizumab mend the gut? new trial aims for deep healing in Crohn's

NCT ID NCT07292012

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests if the drug mirikizumab can heal damage deep in the gut wall in people with Crohn's disease. About 75 adults with active symptoms and inflammation seen on MRI will receive the drug. The main goal is to see if the gut shows at least 25% improvement after 24 weeks.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

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

Started

May 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patients with CD * ≥ 18 to ≤ 75 years-old * Symptomatic CD according to PRO-2 (stool \> 3 or abdominal pain score \> 1) * Transmural inflammation on baseline MRI (C-score \> 0.5 in at least one segment) Exclusion Criteria: * Prior exposure to anti-p19 biological therapy * Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase \[JAK\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents * Exclude any previous use of p19 IL23s agents * Contra-indication to mirikizumab * Definitive ostomy * Colectomy with IPAA * Isolated or uncontrolled perianal lesions * Severe obstructive symptoms * Intra-abdominal abscess * Contra-indication to MRI * No health insurance * Pregnant or lactating women * Patients already included in biomedical research other than an observational study (e.g., registry, cohort) * Concomitant Clostridioides difficile infection * HIV infection * Patient under guardianship, curatorship or safeguard of justice

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn disease (CD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites. 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

  • CH de Valence

    NOT_YET_RECRUITING

    Valence, 26000, France

  • CHU de Brest - Hôpital de la Cavale Blanche

    NOT_YET_RECRUITING

    Brest, 29200, France

  • CHU de Clermont Ferrand - Hôpital d'Estaing

    RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU de Nîmes Carémeau

    NOT_YET_RECRUITING

    Nîmes, 30029, France

  • CHU de Toulouse - Hôpital Rangueil

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Institut Mutualiste Monsouris

    NOT_YET_RECRUITING

    Paris, 75674, France

More trials for these conditions

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