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

February 25, 2025 updated by: Inotrem

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marc Derive, PhD
  • Phone Number: 0033966817900
  • Email: md@inotrem.com

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • IRCCS San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative colitis (UC)
20 patients with moderate to severe UC under endoscopic surveillance for their disease
Other: Additional biopsies and blood samples
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)
20 patients with moderate to severe CD under endoscopic surveillance for their disease
Other: Additional biopsies and blood samples
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist
Time Frame: 20 months
Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist
20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound
Time Frame: 26 months
Measurement of pro-inflammatory cytokine concentrations (pg/ml)
26 months
Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound
Time Frame: 26 months
RNAseq analysis
26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inotrem

Collaborators

IRCCS San Raffaele

Investigators

  • Study Director: Jean-Jacques Garaud, MD PhD, Inotrem S.A.
  • Principal Investigator: Silvio Danese, MD PhD, IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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