Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/2025-521889-95-00
2025-521889-95-00RecruitingPhase 4

Efficacy of MIrikizumab to achieve traNsmural healing in patiENTs with Crohn’s Disease : EMINENT CD

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif6 sites in 1 country110 target enrollmentStarted: February 5, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
110
Locations
6
Primary Endpoint
Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To describe the efficacy of mirikizumab therapy to achieve transmural response in patients with CD.

Study Design

Allocation
Not Applicable
Primary Purpose
Experimental arm - mirikizumab
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with CD
  • •≥ 18 years-old ≤ 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
  • •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
  • •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
  • •Contra-indication to mirikizumab
  • •Definitive ostomy
  • •Colectomy with IPAA
  • •Isolated or uncontrolled perianal lesions
  • •Severe obstructive symptoms
  • •Intra-abdominal abscess
  • •Contra-indication to MRI

Outcomes

Primary Outcomes

Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24

Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24

Secondary Outcomes

  • Composite endpoint combining clinical remission and transmural response (TR25) at 6 months
  • Clinical remission will be defined according to PRO-2
  • Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline
  • Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points
  • BU Remission was defined as UNRS =<2
  • Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline
  • Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition
  • Complete transmural healing: C-score = 0 in each active segment at baseline
  • MaRIA at 6 months
  • IUS transmural response/healing at week 4,8, 12 and 24
  • Bowel damage (Lemann Index) at 6 and 18 months
  • Clinical response and remission at week 4,8, 12 and 24
  • Biochemical remission at week 4,8, 12 and 24
  • Drug retention
  • IBD-disability index
  • IBDQ
  • 10 points-Acceptability numerical scale (ANS)
  • Adverse events and severe adverse events

Investigators

Sponsor
Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

Anthony BUISSON

Scientific

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Study Sites (6)

Loading locations...

Similar Trials

Recruiting
Phase 2
Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study.
2023-509707-32-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting25
Recruiting
Phase 1
Trastuzumab Deruxtecan, and pembrolizumab in participants with Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
2023-509866-39-00Daiichi Sankyo Inc.76
Active, not recruiting
Phase 4
DARA-MVI Study (Daratumumab for Microvascular Inflammation in Kidney Transplantation)
NCT07274462University Hospital, Martin20
Recruiting
Phase 2
Olaparib and durvalumab (MEDI4736) in patients with metastatic pancreatic cancer and DNA Damage Repair genes alterations
2024-510970-26-00Asociacion Grupo Tratamiento De Tumores Digestivos40
Not yet recruiting
Phase 2
A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors
NCT07343453Sun Yat-sen University38