Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT07576452 Sponsor: University Hospital, Clermont-Ferrand Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT07576452
Not Yet 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 ulcerative colitis (UC) for at least 3 months
  • You are between 18 and 65 years old
  • Your ulcerative colitis is considered moderate to severe, based on a specific scoring system used by doctors
  • A camera examination of your bowel (colonoscopy) has shown a certain level of inflammation, based on a specific score
  • Your condition has not responded well enough to, stopped working with, or you could not tolerate treatments such as 5-ASA medications, steroids, or immune-suppressing drugs
  • You are able to understand the trial and give your consent to take part
  • You are covered by the French healthcare system
  • If you are a woman who could become pregnant, you must be using an approved form of contraception (such as an implant, the pill, a female condom, or abstinence) for the full duration of the study, and have a negative pregnancy test

Who may not be able to join:

  • You have a medical reason that means you cannot take certain medications used in this trial (confirm with trial site)
  • You have been taking steroids at a dose higher than 20 mg per day within the two weeks before joining
  • Your ulcerative colitis only affects a very small area of the rectum (less than 5 cm)
  • You have a history of blood clots (such as deep vein thrombosis or pulmonary embolism)
  • You have a history of serious heart or cardiovascular problems, such as a heart attack or stroke
  • You are a long-term heavy smoker with more than 40 pack-years of smoking history (confirm with trial site)
  • You have Crohn's disease
  • You have had a stoma (a surgically created opening in the abdomen) or have had part or all of your colon removed
  • You have previously been treated with certain types of biological or targeted medicines, including anti-TNF agents, anti-integrin drugs, anti-interleukin 12/23 drugs, or JAK inhibitors
  • You have previously used other biological treatments or experimental drugs
  • You do not have health insurance
  • You are pregnant or currently breastfeeding
  • You are already taking part in another clinical (biomedical research) trial (observational studies such as registries or cohorts may be acceptable — confirm with trial site)
  • You currently have a Clostridioides difficile gut infection
  • You have HIV infection
  • You are not able to communicate in French
  • You are under legal guardianship or a similar form of legal protection
  • You are under 18 years old

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 16 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, University Hospital, Clermont-Ferrand

Phone: 334.73.754.963

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
Not Yet Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 June 2030

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Clinical remission

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: 16 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