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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Not yet enrolling; Phase 4

Conditions: Crohn Disease (CD)

Treatments: Drug: Mirikizumab - IV; Drug: Mirikizumab - SC

Study type: Interventional

Funder types: Other

Identifiers

NCT07292012

GETAID-2025-02

2025-521889-95-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Mirikizumab treatment

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab - SC

Drug: Mirikizumab - IV