Crohn Disease (CD)Phase 4EMINENT-CDNCT07292012
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
A Phase 4 study testing Mirikizumab - IV and Mirikizumab - SC in people with Crohn Disease (CD), run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 8 sites in France.
Trial summary
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Mirikizumab - IV and Mirikizumab - SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 8 sitesFrance
- Study dates
- 11 May 2026to Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 7 recruiting
- Recruiting
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29200
Franck CHOLET, MD, +33 2 98 34 71 15, franck.cholet@chu-brest.fr
- Not yet recruiting
CHU Caen Normandie
Caen, 14033
Oumniya ARJAFALLAH, Dr, +33231063104, arjafallah-o@chu-caen.fr
- Recruiting
CHU de Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63003
Anthony BUISSON, MD, +33 4 73 75 05 23, a_buisson@chu-clermontferrand.fr
- Recruiting
CHU de Nîmes Carémeau
Nîmes, 30029
Ludovic CAILLO, MD, +33 4 66 68 31 83, Ludovic.CAILLO@chu-nimes.fr
- Active, not recruiting
Institut Mutualiste Monsouris
Paris, 75674
- Not yet recruiting
CHU Poitiers
Poitiers, 86000
Gaelle SICKERSEN, Dr, +33549443044, gaelle.sickersen@chu-poitiers.fr
- Recruiting
CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059
Cyrielle GILLETTA, MD, +33 5 61 32 27 63, gilletta.c@chu-toulouse.fr
- Recruiting
CH de Valence
Valence, 26000
Céline MONTUCLARD, MD, +33475757512, cmontuclard@ch-valence.fr
About this study
Official title: 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
- Conditions
- Crohn Disease (CD)
- Being tested
- Mirikizumab - IV, Mirikizumab - SC
- Keywords
- crohn's disease, transmural healing, mirikizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab - IVDrug
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
Mirikizumab - SCDrug
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab treatment | Experimental | 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 Receives: Drug: Mirikizumab - IV; Drug: Mirikizumab - SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From week 0 to week 24
Secondary outcomes (9)
Clinical remission
Clinical remission will be defined according to PRO-2 (Patient Report Outcome)
Measured: 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)
Measured: 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
Measured: 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
Measured: Week 0, Week 24, Week 76
Transmural healing
Transmural healing is defined as a C-score < 0.5 in each active segment at baseline
Measured: at Week 0, Week 24, Week 76
Disease activity
Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)
Measured: Week 0, Week 24, Week 76
IUS transmural response/healing
IUS transmural response/healing
Measured: Week 4, Week 8, Week 12, Week 24
Bowel damage
Bowel damage is measured with the Lemann Index
Measured: 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
Measured: Week 0, Week 4, Week 24, Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start11 May 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony BUISSON, MD, Principal investigator, University Hospital, Clermont-FerrandGuillaume LE COSQUER, MD, Principal investigator, CHU de Toulouse- Hôpital Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292012
- Sponsor's protocol ID
- GETAID-2025-02
- Other IDs
- 2025-521889-95-00, 2025
- Acronym
- EMINENT-CD
- Status last verified
- Nov 2026
- First submitted
- 24 Nov 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD
- ClinicalTrials.gov ID
- NCT07292012
- Acronym / sponsor ID
- EMINENT-CD / GETAID-2025-02
- Conditions
- Crohn Disease (CD)
- Keywords
- crohn's disease, transmural healing, mirikizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab treatment | Experimental | Drug: Mirikizumab - IV, Drug: Mirikizumab - SCMirikizumab 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirikizumab - IVMirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8. | Drug | Mirikizumab treatment |
| Mirikizumab - SCSC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders | Drug | Mirikizumab treatment |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony BUISSON, MD principal investigator
University Hospital, Clermont-Ferrand
Guillaume LE COSQUER, MD principal investigator
CHU de Toulouse- Hôpital Rangueil
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab - IV and Mirikizumab - SC in people with Crohn Disease (CD), run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie MUSSOT (+33 6 27 49 29 10, jmussot@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmural response (TR25) (time frame: From week 0 to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.