NCT07292012

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
33mo left

Started Jan 2026

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

November 24, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

November 24, 2025

Last Update Submit

December 5, 2025

Conditions

Crohn Disease (CD)

Keywords

crohn's diseasetransmural healingmirikizumab

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Clinical remission

    Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

  • Improvement or normalization of bowel urgency

    Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

  • BU clinical meaningful improvement

    Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76

  • Transmural response (TR50)

    Week 0, Week 24, Week 76

  • Transmural healing

    at Week 0, Week 24, Week 76

  • +4 more secondary outcomes

Study Arms (1)

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

Drug: Mirikizumab - IVDrug: Mirikizumab - SC

Interventions

Mirikizumab - IVDRUG

Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.

Mirikizumab treatment
Mirikizumab - SCDRUG

SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders

Mirikizumab treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU de Brest - Hôpital de la Cavale Blanche

Brest, 29200, France

Location

CHU de Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, 63003, France

Location

CHU de Nîmes Carémeau

Nîmes, 30029, France

Location

Institut Mutualiste Monsouris

Paris, 75674, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

CH de Valence

Valence, 26000, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Anthony BUISSON, MD

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Guillaume LE COSQUER, MD

    CHU de Toulouse- Hôpital Rangueil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte MAILHAT

CONTACT

+33 9 72 57 61 60cmailhat@getaid.org

Noemie DA COSTA

CONTACT

+33 9 72 57 61 60ndacosta@getaid.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 18, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

FR(6)