Evaluating biomarkers in patients with moderate to severe ulcerative colitis receiving targeted therapies

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 observational study aims to identify biomarkers in blood, stool, and tissue that can predict the response to various targeted therapies in patients with moderate to severe ulcerative colitis. By understanding these biomarkers, the study seeks to enhance personalized medicine approaches, ensuring that patients receive the most effective treatment based on their individual profiles. The study will involve procedures such as endoscopic biopsies, blood sampling, and stool sampling to gather necessary data. The ultimate goal is to improve treatment outcomes for patients suffering from this chronic inflammatory bowel disease.

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 ICF)
* Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
* Moderate to severe active UC defined by Mayo Score ≥ 6
* Moderate to severe active UC defined by endoscopy score of ≥2
* Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, 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 an endoscopy for the assessment of disease activity as for standards of care and current guidelines
* Able to comply with the study procedures
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and able to sign informed consent form

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
* Absolute contraindications to endoscopy procedures or 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 (haemoglobin \< 10 g/dl) at baseline
* Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason
* 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

• Central Hospital
  Nancy, Lorraine, France Recruiting

Study contacts

• Study coordinator: Laurent MD Peyrin-Biroulet, PhD
• Email: peyrinbiroulet@gmail.com
• Phone: 0383153661

Similar studies

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

• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

  This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.

  Recruiting at 4 sites Phase 2 Athos Therapeutics Inc · Miami, Florida and 3 other locations · NCT07513181

• Self-management program to improve health in inflammatory bowel disease

  A digital self-management program is being tested to see if it helps people with inflammatory bowel disease feel better and manage their symptoms alongside standard care.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07456566

• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

  This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.

  Recruiting Phase 1 University of Alberta · Calgary, Alberta and 1 other locations · NCT07401680

• Long-acting antibody treatments alone and in combinations for moderate to severe ulcerative colitis

  This tests long-acting antibody medicines, given after an IV induction and then as under-the-skin maintenance, to see if they help adults with moderate to severe ulcerative colitis.

  Recruiting at 276 sites Phase 2 Spyre Therapeutics, Inc. · Canoga Park, California and 275 other locations · NCT07012395

• Observational study comparing inflammatory markers in IBD and non-IBD participants

  This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

  Recruiting University of Nottingham · Nottingham, Nottinghamshire · NCT06956703

• Evaluating robotic surgery for inflammatory bowel disease

  This study is testing if robotic surgery can be a good option for adults with inflammatory bowel disease, like Crohn's or ulcerative colitis, compared to traditional surgery methods.

  Recruiting at 6 sites University Hospitals Coventry and Warwickshire NHS Trust · Coventry, West Midlands and 5 other locations · NCT06579443

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.