Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease (EMINENT-CD)

Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD

Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Drug: Mirikizumab - IV; Drug: Mirikizumab - SC

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Noemie DA COSTA; Phone Number: +33 9 72 57 61 60; Email: ndacosta@getaid.org
• Study Contact Backup: Name: Julie MUSSOT; Phone Number: +33 6 27 49 29 10; Email: jmussot@getaid.org

Study Locations

• France
  • Brest, France, 29200
    • Not yet recruiting
    • CHU de Brest - Hopital de la Cavale Blanche
    • Contact: Franck CHOLET, MD; Phone Number: +33 2 98 34 71 15; Email: franck.cholet@chu-brest.fr
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU de Clermont Ferrand - Hôpital d'Estaing
    • Contact: Anthony BUISSON, MD; Phone Number: +33 4 73 75 05 23; Email: a_buisson@chu-clermontferrand.fr
  • Nîmes, France, 30029
    • Not yet recruiting
    • CHU de Nîmes Carémeau
    • Contact: Ludovic CAILLO, MD; Phone Number: +33 4 66 68 31 83; Email: Ludovic.CAILLO@chu-nimes.fr
  • Paris, France, 75674
    • Not yet recruiting
    • Institut Mutualiste Monsouris
    • Contact: Marion SIMON, MD; Phone Number: +33 1 56 61 63 14; Email: Marion.Simon@imm.fr
  • Toulouse, France, 31059
    • Not yet recruiting
    • CHU de Toulouse - Hôpital Rangueil
    • Contact: Cyrielle GILLETTA, MD; Phone Number: +33 5 61 32 27 63; Email: gilletta.c@chu-toulouse.fr
  • Valence, France, 26000
    • Not yet recruiting
    • CH de Valence
    • Contact: Céline MONTUCLARD, MD; Phone Number: +33475757512; Email: cmontuclard@ch-valence.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Mirikizumab - IV; Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.; Drug: Mirikizumab - SC; SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transmural response (TR25)	Transmural response (TR25) define as the decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24	From week 0 to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission	Clinical remission will be defined according to PRO-2 (Patient Report Outcome)	Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Improvement or normalization of bowel urgency	Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale)	Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
BU clinical meaningful improvement	BU clinical meaningful improvement was defined as decrease of >=3 points; BU Remission was defined as UNRS =<2	Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Transmural response (TR50)	Transmural response (TR50) is defined as a decrease of at least 50% of C-score in each active segment at baseline	Week 0, Week 24, Week 76
Transmural healing	Transmural healing is defined as a C-score < 0.5 in each active segment at baseline	at Week 0, Week 24, Week 76
Disease activity	Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)	Week 0, Week 24, Week 76
IUS transmural response/healing	IUS transmural response/healing	Week 4, Week 8, Week 12, Week 24
Bowel damage	Bowel damage is measured with the Lemann Index	Week 24, Week 76
Transmural response (TR25)	Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline	Week 0, Week 4, Week 24, Week 76

Collaborators and Investigators

• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Investigators: Principal Investigator: Guillaume LE COSQUER, MD, CHU de Toulouse- Hôpital Rangueil; Principal Investigator: Anthony BUISSON, MD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: crohn's disease; mirikizumab; transmural healing
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GETAID-2025-02; 2025-521889-95-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No