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NCT Number: NCT06580418

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

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

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

    Time frame: 26 months

    RNAseq analysis

Sponsors and collaborators

Lead sponsor

Inotrem

Industry

Collaborators

  • IRCCS San Raffaele

Registry information

Acronym: TIME

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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