Understanding why some patients with inflammatory bowel disease don't respond to therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the molecular mechanisms behind the lack of response to therapy in patients suffering from inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis. It will involve collecting samples from patients who have been diagnosed with these conditions and are experiencing moderate to severe disease activity. The research will focus on identifying biomarkers that could explain the variability in treatment responses among patients. By understanding these mechanisms, the study hopes to improve therapeutic strategies for individuals with IBD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
* Person informed about study organization and having signed the informed consent.
* Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum disease duration of 3 months
* Moderate to severe disease activity

  * UC : Mayo Score ≥ 6 including endoscopy score of ≥ 2
  * CD : CDAI score betwenn 220 and 450 (inclusive)
* Indication to start any biological or small molecule agent (anti-TNF, anti-IL 21/23, anti-integrin and JAK-inhibitors)
* In case of treatment with corticosteroid : stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
* Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
* Absolute contraindications to colonoscopy procedures, complication during previous endoscopy
* Bleeding disorders
* Indication for surgery for UC
* Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
* Treatment with \> 20 mg prednisone within 3 weeks prior to baseline
* Anaemia (haemoglobbin \< 10g/dl) at baseline
* Subject unable to comply with the study procedures
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Minor person (non-emancipated)
  * Adult person under legal protection (any form of public guardianship)
  * Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Where it's running

• CHRU of Nancy
  Vandœuvre-lès-Nancy, CHRU de Nancy, France Recruiting

Study contacts

• Principal investigator: Laurent PEYRIN-BIROULET — CHRU of Nancy, Hepatogastroenterology Department
• Study coordinator: Laurent PEYRIN-BIROULET, PU-PH
• Email: peyrinbiroulet@gmail.com
• Phone: 03.83.15.36.61

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

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• Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

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• Pregnancy in people with inflammatory bowel disease

  This project will see if pregnancy changes how often women with IBD have disease flares by analyzing registry data from women who had pregnancies.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07377188

• Evaluating Upadacitinib for Inflammatory Bowel Disease

  This study is testing how well the oral medication Upadacitinib works for people in China with Inflammatory Bowel Disease who haven't responded to other treatments.

  Recruiting at 6 sites Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong and 5 other locations · NCT06780683

• Continued TAK-279 treatment in adults with ulcerative colitis or Crohn's disease

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• Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

  This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

  Recruiting at 78 sites Phase 4 Takeda · Birmingham, Alabama and 100 other locations · NCT06581328

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.