Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
Phase 4 · Testing Mirikizumab - IV and Mirikizumab - SC · 6 sites · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mirikizumab - IV (a drug) and Mirikizumab - SC (a drug) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Crohn Disease (CD).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Patients with CD
- ≥ 18 to ≤ 75 years-old
- Symptomatic CD according to PRO-2 (stool > 3 or abdominal pain score > 1)
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 75 participants are expected to take part.
- Start date: 2026-05-11.
- Main results expected around 2027-11 (estimate from the record).
- 6 study sites listed (1 marked recruiting) in France.
Main thing being measured
- Transmural response (TR25) (From week 0 to week 24)
In the researchers’ words
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Enrollment | 75 (estimated) |
| Start date | 2026-05-11 |
| Primary completion (est.) | 2027-11 |
| First posted | 2025-12-18 |
| Last updated | 2026-05-26 |
| Official title | Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD |
| ClinicalTrials.gov ID | NCT07292012 |
Interventions
- 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
Full eligibility criteria (from the record)
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
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Brest - Hôpital de la Cavale Blanche | Brest | France | Not yet recruiting |
| CHU de Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | France | Recruiting |
| CHU de Nîmes Carémeau | Nîmes | France | Not yet recruiting |
| Institut Mutualiste Monsouris | Paris | France | Not yet recruiting |
| CHU de Toulouse - Hôpital Rangueil | Toulouse | France | Not yet recruiting |
| CH de Valence | Valence | France | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.