A Phase 4 interventional study of Mirikizumab - IV and Mirikizumab - SC in Crohn Disease (CD), sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 6 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Phase 4, Interventional, and Supportive care
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Exclusion Criteria:
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
Drug: Mirikizumab - IV · Drug: Mirikizumab - SC
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
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
Time frame: From week 0 to week 24
Clinical remission
Clinical remission will be defined according to PRO-2 (Patient Report Outcome)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Week 0, Week 24, Week 76
Transmural healing
Transmural healing is defined as a C-score \< 0.5 in each active segment at baseline
Time frame: at Week 0, Week 24, Week 76
Disease activity
Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)
Time frame: Week 0, Week 24, Week 76
IUS transmural response/healing
IUS transmural response/healing
Time frame: Week 4, Week 8, Week 12, Week 24
Bowel damage
Bowel damage is measured with the Lemann Index
Time frame: 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
Time frame: Week 0, Week 4, Week 24, Week 76
Plan to share: Undecided
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives