Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model

Recruiting

• Conditions: Inflammatory Bowel Diseases

• 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

Study Timeline

• Study Start: 2023-01-31
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

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

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