Can mirikizumab mend the gut? new trial aims for deep healing in Crohn's
NCT ID NCT07292012
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 Hide 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.
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.
-
The places running it
6 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGValence, 26000, France
-
CHU de Brest - Hôpital de la Cavale Blanche
NOT_YET_RECRUITINGBrest, 29200, France
-
CHU de Clermont Ferrand - Hôpital d'Estaing
RECRUITINGClermont-Ferrand, 63003, France
-
CHU de Nîmes Carémeau
NOT_YET_RECRUITINGNîmes, 30029, France
-
CHU de Toulouse - Hôpital Rangueil
NOT_YET_RECRUITINGToulouse, 31059, France
-
Institut Mutualiste Monsouris
NOT_YET_RECRUITINGParis, 75674, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Triple-Pronged attack on gut inflammation put to the test
- Can tissue clues predict which Crohn's patients relapse after surgery?
- Exercise as a potential remedy for IBD-related fatigue
- AI reads capsule endoscopy videos to hunt for Crohn's lesions
- Can a simple ultrasound replace MRI for fistula diagnosis?