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Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease

ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Mirikizumab - IV

    Drug

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

  • Mirikizumab - SC

    Drug

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

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Mirikizumab treatmentExperimental treatment 2 interventions

Trial outcomes

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

Time frame
From week 0 to week 24

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Lead sponsor

Source ClinicalTrials.gov
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