Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
NCT ID: NCT07292012
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
110 participants
INTERVENTIONAL
2026-01-31
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Mirikizumab treatment
Mirikizumab will be used as scheduled in the drug label: induction with IV infusions (900 mg) at week 0, week 4 and week 8.
For clinical responders: SC injections (300 mg) at W12 and every 4 weeks For clinical non-responders: SC injections (300 mg) at W12 and every 4 weeks
Mirikizumab - IV
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
Mirikizumab - SC
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
Interventions
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Mirikizumab - IV
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
Mirikizumab - SC
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Anthony BUISSON, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Clermont-Ferrand
Guillaume LE COSQUER, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Toulouse- Hôpital Rangueil
Locations
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CHU de Brest - Hôpital de la Cavale Blanche
Brest, , France
CHU de Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, , France
CHU de Nîmes Carémeau
Nîmes, , France
Institut Mutualiste Monsouris
Paris, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
CH de Valence
Valence, , France
Countries
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Central Contacts
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Facility Contacts
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Franck CHOLET, MD
Role: primary
Anthony BUISSON, MD
Role: primary
Ludovic CAILLO, MD
Role: primary
Marion SIMON, MD
Role: primary
Cyrielle GILLETTA, MD
Role: primary
Céline MONTUCLARD, MD
Role: primary
Other Identifiers
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2025-521889-95-00
Identifier Type: CTIS
Identifier Source: secondary_id
GETAID-2025-02
Identifier Type: -
Identifier Source: org_study_id