Inflammatory Bowel DiseasesTIMENCT06580418
Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
An observational study of Inflammatory Bowel Diseases, run by Inotrem at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Additional biopsies and blood samples
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients between 18 and 60 years
- Signed informed consent
- Ulcerative colitis (UC) patients with active disease
- Crohn's disease (CD) patients with active disease
Who cannot join
- UC or CD patients in remission
- Patients between 18 and 60 years without informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan
Silvio Danese, MD, +39 02.26431, danese.silvio@hsr.it
About this study
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
- Being tested
- Additional biopsies and blood samples
- Keywords
- IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biopsies and blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis (UC) | 20 patients with moderate to severe UC under endoscopic surveillance for their disease Receives: Other: Additional biopsies and blood samples | |
| Crohn's Disease (CD) | 20 patients with moderate to severe CD under endoscopic surveillance for their disease Receives: Other: Additional biopsies and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measurement of pro-inflammatory cytokine concentrations (pg/ml)
Measured: 26 months
Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound
RNAseq analysis
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start31 Jan 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inotrem
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580418
- Sponsor's protocol ID
- TIME
- Acronym
- TIME
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
- ClinicalTrials.gov ID
- NCT06580418
- Acronym / sponsor ID
- TIME / TIME
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- InotremIndustry (pharma, biotech, devices)
- Collaborators
- IRCCS San Raffaele
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis (UC) | – | Other: Additional biopsies and blood samples20 patients with moderate to severe UC under endoscopic surveillance for their disease |
| Crohn's Disease (CD) | – | Other: Additional biopsies and blood samples20 patients with moderate to severe CD under endoscopic surveillance for their disease |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Patients between 18 and 60 years
- Signed informed consent
- Ulcerative colitis (UC) patients with active disease
- Crohn's disease (CD) patients with active disease
Key exclusion criteria (2 listed)
- UC or CD patients in remission
- Patients between 18 and 60 years without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional biopsies and blood samplesDuring 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. | Other | Crohn's Disease (CD), Ulcerative colitis (UC) |
Primary outcome
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
2 secondary outcomes
Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound
Time frame: 26 months
Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound
Time frame: 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Inotrem at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.