Crohn Disease (CD)
Conditions
Keywords
crohn's disease, transmural healing, mirikizumab
Brief summary
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Interventions
DRUGMirikizumab - IV
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
DRUGMirikizumab - SC
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
Sponsors
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transmural response (TR25) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76 | Clinical remission will be defined according to PRO-2 (Patient Report Outcome) |
| Improvement or normalization of bowel urgency | Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76 | Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale) |
| BU clinical meaningful improvement | Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76 | BU clinical meaningful improvement was defined as decrease of \>=3 points; BU Remission was defined as UNRS =\<2 |
| Transmural response (TR50) | Week 0, Week 24, Week 76 | Transmural response (TR50) is defined as a decrease of at least 50% of C-score in each active segment at baseline |
| Transmural healing | at Week 0, Week 24, Week 76 | Transmural healing is defined as a C-score \< 0.5 in each active segment at baseline |
| Disease activity | Week 0, Week 24, Week 76 | Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity) |
| IUS transmural response/healing | Week 4, Week 8, Week 12, Week 24 | IUS transmural response/healing |
| Bowel damage | Week 24, Week 76 | Bowel damage is measured with the Lemann Index |
| Transmural response (TR25) | Week 0, Week 4, Week 24, Week 76 | Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline |
Countries
France
Contacts
CONTACTJulie MUSSOT
CONTACTNoemie DA COSTA
PRINCIPAL_INVESTIGATORAnthony BUISSON, MD
University Hospital, Clermont-Ferrand
PRINCIPAL_INVESTIGATORGuillaume LE COSQUER, MD
CHU de Toulouse- Hôpital Rangueil
Outcome results
None listed