Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT05456893
Recruiting Observational

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

NCT05456893 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Observational
Started
2022-07-28
Last updated
2025-05-06

Condition(s) studied

Ulcerative ColitisInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Procedure: endoscopic biopsyBlood samplingstool sampling

Procedure: endoscopic biopsy: Per-endoscopic biopsies

Blood sampling: Blood sampling

stool sampling: stool sampling

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The percentage of subjects who achieve clinical response at week 14. — The percentage of subjects who achieve clinical response at week 14
    Clinical response will be defined as overall Mayo score of 2 or smaller with Mayo endoscopy score (Mayo ES) of 0 or 1 (without friability), and bleeding subscore of 0. The Clinical Response will be categorized in four subcategories: * Super responder: meets criteria of clinical response * Responder: Mayo Score: reduction of 50%/ improvement of ≥ 3 from baseline, but does not meet criteria of remission; endoscopic Mayo: does not meet criteria of clinical response, but shows reduction of Mayo ES * Partial responder: Mayo Score: reduction of up to 30%, endoscopic Mayo: no formal improvement by Mayo ES but in overall assessment by the physician slight improvement. * Non-responder: reduction of less than 30% and in endoscopy no improvement in the overall assessment
  • The percentage of subjects who achieve deep clinical remission at week 14. — The percentage of subjects who achieve deep clinical remission at week 14
    Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
  • The percentage of subjects who achieve deep clinical remission at week 26. — The percentage of subjects who achieve deep clinical remission at week 26.
    Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
  • The percentage of subjects who achieve deep clinical remission at week 52. — The percentage of subjects who achieve deep clinical remission at week 52.
    Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
  • The percentage of subjects who achieve mucosal healing at week 14. — The percentage of subjects who achieve mucosal healing at week 14.
    Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
  • The percentage of subjects who achieve mucosal healing at week 52. — The percentage of subjects who achieve mucosal healing at week 52.
    Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
  • The percentage of subjects who achieve symptomatic remission at week 14. — The percentage of subjects who achieve symptomatic remission at week 14.
    Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
  • The percentage of subjects who achieve symptomatic remission at week 26. — The percentage of subjects who achieve symptomatic remission at week 26.
    Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
  • The percentage of subjects who achieve symptomatic remission at week 52. — The percentage of subjects who achieve symptomatic remission at week 52.
    Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).

Trial sites (1)

FacilityCityRegionStatus
Central Hospital Nancy Lorraine Recruiting

More Central Hospital, Nancy, France trials in France

New CSF Biomarkers for Alzheimer's Disease Recruiting
Effect of Early Empagliflozin Initiation in Cardiogenic Shock. Active, not recruiting
Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion Recruiting
One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease Starting soon
Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation Recruiting

Other trials for the same condition

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Active, not recruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER). Starting soon
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting
A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05456893 on ClinicalTrials.gov ↗ ← All trials in France