RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Mirikizumab - IV for Crohn Disease (CD)

How well it works of Mirikizumab to achieve transmural healing in patients with Crohn's Disease

Official registry: https://clinicaltrials.gov/study/NCT07292012 · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · enrollment listed as 75

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Mirikizumab - IV, or Mirikizumab - SC. The registry lists allocation as na. How well it works of Mirikizumab to achieve transmural healing in patients with Crohn's Disease

They plan to enroll about 75 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD

Interventions: Mirikizumab - IV, Mirikizumab - SC

Primary outcome (registry wording): Transmural response (TR25)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
≥ 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)

Who the registry excludes

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
Colectomy with IPAA
Isolated or uncontrolled perianal lesions
Severe obstructive symptoms

Public study contact (from the registry)

Julie MUSSOT

+33 6 27 49 29 10

jmussot@getaid.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

CHU de Brest - Hôpital de la Cavale Blanche — Brest, France (recruiting)
CHU Caen Normandie — Caen, France (not_yet_recruiting)
CHU de Clermont Ferrand - Hôpital d'Estaing — Clermont-Ferrand, France (recruiting)
CHU de Nîmes Carémeau — Nîmes, France (recruiting)
Institut Mutualiste Monsouris — Paris, France (active_not_recruiting)
CHU Poitiers — Poitiers, France (not_yet_recruiting)
CHU de Toulouse - Hôpital Rangueil — Toulouse, France (recruiting)
CH de Valence — Valence, France (recruiting)

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FAQ about this NCT record

Is NCT07292012 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07292012?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07292012?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary