Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
Recruiting
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: Additional biopsies and blood samples
- Registration Number
- NCT06580418
- Lead Sponsor
- Inotrem
- Brief Summary
TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.
The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients between 18 and 60 years
- Signed informed consent
- Ulcerative colitis (UC) patients with active disease
- Crohn's disease (CD) patients with active disease
Exclusion Criteria
- UC or CD patients in remission
- Patients between 18 and 60 years without informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Crohn's Disease (CD) Additional biopsies and blood samples 20 patients with moderate to severe CD under endoscopic surveillance for their disease Ulcerative colitis (UC) Additional biopsies and blood samples 20 patients with moderate to severe UC under endoscopic surveillance for their disease
- Primary Outcome Measures
Name Time Method Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist 20 months Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist
- Secondary Outcome Measures
Name Time Method Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound 26 months Measurement of pro-inflammatory cytokine concentrations (pg/ml)
Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound 26 months RNAseq analysis
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milano, Italy