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NCT Number: NCT07292012

Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease

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

Recruiting

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Brest - Hôpital de la Cavale Blanche, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirikizumab - IV

Drug

Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.

Mirikizumab - SC

Drug

SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders

Primary outcomes

  1. Transmural response (TR25)

    Time frame: From week 0 to week 24

    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

Secondary outcomes

  1. Clinical remission

    Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

    Clinical remission will be defined according to PRO-2 (Patient Report Outcome)

  2. Improvement or normalization of bowel urgency

    Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

    Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale)

  3. BU clinical meaningful improvement

    Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

    BU clinical meaningful improvement was defined as decrease of >=3 points; BU Remission was defined as UNRS =<2

  4. Transmural response (TR50)

    Time frame: Week 0, Week 24, Week 76

    Transmural response (TR50) is defined as a decrease of at least 50% of C-score in each active segment at baseline

  5. Transmural healing

    Time frame: at Week 0, Week 24, Week 76

    Transmural healing is defined as a C-score < 0.5 in each active segment at baseline

  6. Disease activity

    Time frame: Week 0, Week 24, Week 76

    Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)

  7. IUS transmural response/healing

    Time frame: Week 4, Week 8, Week 12, Week 24

    IUS transmural response/healing

  8. Bowel damage

    Time frame: Week 24, Week 76

    Bowel damage is measured with the Lemann Index

  9. Transmural response (TR25)

    Time frame: Week 0, Week 4, Week 24, Week 76

    Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Julie MUSSOT

CONTACT

[email protected]

+33 6 27 49 29 10

Noemie DA COSTA

CONTACT

[email protected]

+33 9 72 57 61 60

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

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

Acronym: EMINENT-CD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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