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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521889-95-00 | EU Trial (CTIS) Number |
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Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab - IV | Drug | Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From week 0 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | Clinical remission will be defined according to PRO-2 (Patient Report Outcome) | Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76 |
| Improvement or normalization of bowel urgency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie MUSSOT | Contact | +33 6 27 49 29 10 | jmussot@getaid.org | |
| Noemie DA COSTA | Contact | +33 9 72 57 61 60 | ndacosta@getaid.org |
| Name | Affiliation | Role |
|---|---|---|
| Anthony BUISSON, MD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Guillaume LE COSQUER, MD | CHU de Toulouse- Hôpital Rangueil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest - Hôpital de la Cavale Blanche | Not yet recruiting | Brest | 29200 | France |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Mirikizumab - SC | Drug | SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders |
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Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale)
| 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 | 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 | Week 0, Week 24, Week 76 |
| Transmural healing | Transmural healing is defined as a C-score < 0.5 in each active segment at baseline | at Week 0, Week 24, Week 76 |
| Disease activity | Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity) | Week 0, Week 24, Week 76 |
| IUS transmural response/healing | IUS transmural response/healing | Week 4, Week 8, Week 12, Week 24 |
| Bowel damage | Bowel damage is measured with the Lemann Index | 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 | Week 0, Week 4, Week 24, Week 76 |
| CHU de Clermont Ferrand - Hôpital d'Estaing | Recruiting | Clermont-Ferrand | 63003 | France |
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| CHU de Nîmes Carémeau | Not yet recruiting | Nîmes | 30029 | France |
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| Institut Mutualiste Monsouris | Not yet recruiting | Paris | 75674 | France |
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| CHU de Toulouse - Hôpital Rangueil | Not yet recruiting | Toulouse | 31059 | France |
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| CH de Valence | Not yet recruiting | Valence | 26000 | France |
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| D007410 | Intestinal Diseases |