MIRIKIZUMAB for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Patients with CD\n- ≥ 18 years-old ≤ 75 years old\n- Symptomatic CD according to PRO-2 (stool > 3 or abdominal pain score > 1)\n- Transmural inflammation on baseline MRI (C-score > 0.5 in at least one segment)"}

Exclusion criteria

• {"criterion_text":"- Prior exposure to anti-p19 biological therapy\n- 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\n- Contra-indication to mirikizumab\n- Definitive ostomy\n- Colectomy with IPAA\n- Isolated or uncontrolled perianal lesions\n- Severe obstructive symptoms\n- Intra-abdominal abscess\n- Contra-indication to MRI\n- No health insurance\n- Pregnant or lactating women\n- Patients already included in biomedical research other than an observational study (e.g., registry, cohort)\n- Concomitant Clostridioides difficile infection\n- HIV infection\n- Patient under guardianship, curatorship or safeguard of justice"}

Primary endpoints

• {"endpoint_text":"- Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24","definition_or_measurement_approach":"Decrease of at least 25% of C-score in each active segment from baseline to week 24 (C-score metric; comparison baseline vs week 24)."}

Secondary endpoints

• {"endpoint_text":"- Composite endpoint combining clinical remission and transmural response (TR25) at 6 months","definition_or_measurement_approach":"Composite of clinical remission (per PRO-2) AND transmural response (TR25) at 6 months."}
• {"endpoint_text":"- Clinical remission will be defined according to PRO-2","definition_or_measurement_approach":"Clinical remission defined using PRO-2 instrument."}
• {"endpoint_text":"- Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline","definition_or_measurement_approach":"Transmural response defined as ≥25% decrease in C-score in each active baseline segment."}
• {"endpoint_text":"- Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points","definition_or_measurement_approach":"Bowel urgency measured by UNRS and Urgent score BU; clinically meaningful improvement = decrease ≥3 points."}
• {"endpoint_text":"- BU Remission was defined as UNRS =<2","definition_or_measurement_approach":"BU remission = UNRS ≤ 2."}
• {"endpoint_text":"- Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline","definition_or_measurement_approach":"Transmural response TR50 = ≥50% decrease in C-score in each active baseline segment."}
• {"endpoint_text":"- Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition","definition_or_measurement_approach":"Transmural healing defined as C-score <0.5 in each active baseline segment (TRENCH definition)."}
• {"endpoint_text":"- Complete transmural healing: C-score = 0 in each active segment at baseline","definition_or_measurement_approach":"Complete transmural healing defined as C-score = 0 in each active baseline segment."}
• {"endpoint_text":"- MaRIA at 6 months","definition_or_measurement_approach":"MaRIA score (MRI index) assessed at 6 months."}
• {"endpoint_text":"- IUS transmural response/healing at week 4,8, 12 and 24","definition_or_measurement_approach":"IUS (intestinal ultrasound) assessment of transmural response/healing at weeks 4, 8, 12 and 24."}
• {"endpoint_text":"- Bowel damage (Lemann Index) at 6 and 18 months","definition_or_measurement_approach":"Lemann Index evaluated at 6 and 18 months to assess bowel damage."}
• {"endpoint_text":"- Clinical response and remission at week 4,8, 12 and 24","definition_or_measurement_approach":"Clinical response/remission measured at weeks 4, 8, 12 and 24 (per protocol clinical definitions, e.g., PRO-2)."}
• {"endpoint_text":"- Biochemical remission at week 4,8, 12 and 24","definition_or_measurement_approach":"Biochemical remission (e.g., CRP, faecal calprotectin) assessed at weeks 4, 8, 12 and 24."}
• {"endpoint_text":"- Drug retention","definition_or_measurement_approach":"Assessment of ongoing treatment retention over time."}
• {"endpoint_text":"- IBD-disability index","definition_or_measurement_approach":"Assessment using IBD-disability index instrument."}
• {"endpoint_text":"- IBDQ","definition_or_measurement_approach":"Assessment using the IBDQ (Inflammatory Bowel Disease Questionnaire)."}
• {"endpoint_text":"- 10 points-Acceptability numerical scale (ANS)","definition_or_measurement_approach":"Acceptability measured by 10-point ANS."}
• {"endpoint_text":"- Adverse events and severe adverse events","definition_or_measurement_approach":"Safety monitoring by recording adverse events and serious adverse events per standard definitions."}

France

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

51

Number Of Sites

6

Number Of Participants

110

Primary sponsor

Full Name

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France