A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

Study Purpose

UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification. The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05456893
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stefan MD SCHREIBER, PhD
Principal Investigator Affiliation Christian Albrechts Universität
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis, Inflammatory Bowel Diseases
Arms & Interventions

Arms

: UC patients

All patients with an established ulcerative colitis

Interventions

Procedure: - Procedure: endoscopic biopsy

Per-endoscopic biopsies

Procedure: - Blood sampling

Blood sampling

Procedure: - stool sampling

stool sampling

Contact a Trial Team

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International Sites

Central Hospital, Nancy, Lorraine, France

Status

Recruiting

Address

Central Hospital

Nancy, Lorraine, 54500

Site Contact

Laurent MD PEYRIN-BIROULET, PhD

peyrinbiroulet@gmail.com

0383153661

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