Crohn's Disease and Colitis Trial, Recruiting NCT05456893 Sponsor: Central Hospital, Nancy, France Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05456893
Recruiting Not Applicable

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:

  • Adults aged 18 or older at the time of signing the consent form
  • People who have been diagnosed with ulcerative colitis (UC) for at least 3 months
  • People whose UC is considered moderate to severe, based on a standard scoring system called the Mayo Score (score of 6 or higher)
  • People whose UC is considered moderate to severe based on camera examination of the bowel (score of 2 or higher on that exam)
  • People for whom a doctor has decided it is appropriate to start a biological therapy or small molecule treatment (such as anti-TNF, anti-IL12/23, anti-integrin, or JAK-inhibitor medicines)
  • People taking corticosteroids (steroid tablets) at a stable dose for at least 3 weeks before the study starts, at a dose no higher than 20mg of prednisone per day
  • People who are already scheduled for a bowel camera examination (endoscopy) as part of their usual care
  • People who are able to follow the study procedures
  • People who are covered by a social security plan
  • People who have been informed about the study and are able to sign a consent form

Who may not be able to join:

  • People diagnosed with certain other types of colitis, including indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, or radiation colitis
  • People for whom a bowel camera examination (endoscopy) is not safe, or who have had a serious complication during a previous endoscopy
  • People with bleeding disorders
  • People who need surgery for their UC
  • People who have used rectal treatments such as enemas or suppositories within 2 weeks before the study starts
  • People who have taken more than 20mg of prednisone (steroids) within the 3 weeks before the study starts
  • People with anaemia (low red blood cell levels, specifically haemoglobin below 10 g/dl) at the start of the study
  • People who the study doctor considers unsuitable for any other reason
  • Women who are pregnant, in labour, or breastfeeding
  • People under 18 years of age
  • Adults who are under legal guardianship or protection
  • Adults who are unable to give consent and are not under legal protection
  • People who are detained by a judicial or administrative decision, or who are under certain forms of compulsory psychiatric care

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 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Stefan MD SCHREIBER, PhD, Christian Albrechts Universität

Phone: 0383153661

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 July 2022
Est. completion
9 September 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

The percentage of subjects who achieve clinical response at week 14.; The percentage of subjects who achieve deep clinical remission at week 14.; The percentage of subjects who achieve deep clinical remission at week 26.; The percentage of subjects who achieve deep clinical remission at week 52.; The percentage of subjects who achieve mucosal healing at week 14.; The percentage of subjects who achieve mucosal healing at week 52.; The percentage of subjects who achieve symptomatic remission at week 14.; The percentage of subjects who achieve symptomatic remission at week 26.; The percentage of...

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: 23 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