Recruiting NCT07292012
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirikizumab - IV, Mirikizumab - SC.
- Who it may be relevant to
- Registry conditions: Crohn Disease (CD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD
Overview
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Interventions
- 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
Primary outcome measures
- Transmural response (TR25) [Time frame: From week 0 to week 24]
Secondary outcome measures (9)
- Clinical remission [Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76]
- Improvement or normalization of bowel urgency [Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76]
- BU clinical meaningful improvement [Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76]
- Transmural response (TR50) [Time frame: Week 0, Week 24, Week 76]
- Transmural healing [Time frame: at Week 0, Week 24, Week 76]
- Disease activity [Time frame: Week 0, Week 24, Week 76]
- IUS transmural response/healing [Time frame: Week 4, Week 8, Week 12, Week 24]
- Bowel damage [Time frame: Week 24, Week 76]
- Transmural response (TR25) [Time frame: Week 0, Week 4, Week 24, Week 76]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 6 centers
- CHU de Brest - Hôpital de la Cavale Blanche — Brest
- CHU de Clermont Ferrand - Hôpital d'Estaing — Clermont-Ferrand
- CHU de Nîmes Carémeau — Nîmes
- Institut Mutualiste Monsouris — Paris
- CHU de Toulouse - Hôpital Rangueil — Toulouse
- CH de Valence — Valence
Identifiers
NCT: NCT07292012 · GETAID-2025-02 · 2025-521889-95-00