Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT07292012 Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT07292012
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease (CD)
  • You are between 18 and 75 years old
  • You are currently experiencing symptoms of Crohn's disease, such as having more than 3 loose stools per day or moderate-to-severe abdominal pain (based on a standard symptom score)
  • A recent MRI scan has shown active inflammation through the wall of your intestine in at least one area

Who may not be able to join:

  • You have previously been treated with a specific type of biological medication that targets a protein called "p19" (confirm with trial site)
  • You have already been treated with more than one type of advanced Crohn's disease therapy, including medications such as infliximab, adalimumab, vedolizumab, ustekinumab, JAK inhibitors, or similar approved drugs
  • You have previously used any medication belonging to the "p19 IL-23 blocker" drug group (confirm with trial site)
  • You have a medical reason why you cannot take the study drug, mirikizumab
  • You have had a permanent stoma (a surgical opening on your abdomen for waste collection)
  • You have had your colon removed and have had a specific type of internal pouch surgery (called an IPAA or "J-pouch")
  • You have active fistulas or wounds around the anal area that are not being controlled
  • You have severe symptoms caused by a blockage or narrowing in your bowel
  • You have a collection of infection (abscess) inside your abdomen
  • You have a medical reason why you cannot have an MRI scan
  • You do not have health insurance
  • You are pregnant or currently breastfeeding
  • You are already taking part in another medical research study that involves a treatment or intervention (not just observation)
  • You currently have an active infection called Clostridioides difficile (a type of gut infection)
  • You have HIV infection
  • You are under a legal protection order or have a guardian making decisions on your behalf

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Anthony BUISSON, MD, University Hospital, Clermont-Ferrand

Phone: +33 6 27 49 29 10

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Registry
ClinicalTrials.gov
Start date
11 May 2026
Est. completion
1 November 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Transmural response (TR25)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov