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

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

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

Treatments tested in this trial

  • Mirikizumab - IV
  • Mirikizumab - SC

Treatment groups

75 Participants
are divided into 1 treatment group