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

NCT06580418 | Recruiting DMC

• 1 other identifier: TIME
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD

Outcome Measures

Primary Outcomes (1)

• Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist

  Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist

  20 months

Secondary Outcomes (2)

• Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound

  26 months

• Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound

  26 months

Study Arms (2)

Ulcerative colitis (UC)

20 patients with moderate to severe UC under endoscopic surveillance for their disease

Other: Additional biopsies and blood samples

Crohn's Disease (CD)

20 patients with moderate to severe CD under endoscopic surveillance for their disease

Other: Additional biopsies and blood samples

Interventions

Additional biopsies and blood samples OTHER

During the endoscopic procedure planned for IBD patients following standard clinical practice, the endoscopist will decide the number and location of additional biopsy samples (up to 8) collected for the study. Participation in this study also requires the removal of three additional blood samples.

Crohn's Disease (CD); Ulcerative colitis (UC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population that will be recruited for this study will be composed of patients with UC or CD under endoscopic surveillance for monitoring the clinical activity of their disease. The recruited patients will firstly sign the informed consent before undergoing the same day the blood withdrawal and endoscopy according to standard of care practice in the dedicated department, under the direction of the Gastroenterology and Digestive Endoscopy operative unit of the San Raffaele Hospital.

You may qualify if:

• Patients between 18 and 60 years
• Signed informed consent
• Ulcerative colitis (UC) patients with active disease
• Crohn's disease (CD) patients with active disease

You may not qualify if:

• UC or CD patients in remission
• Patients between 18 and 60 years without informed consent

Sponsors & Collaborators

• Inotrem: lead
• IRCCS San Raffaele: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: January 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)