NCT07824726Not yet recruiting
Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate whether simultaneously targeting three inflammatory pathways (TL1A, IL-23, and α4β7) produces a stronger anti-inflammatory effect in intestinal tissue from patients with Inflammatory Bowel Disease (IBD) compared with targeting individual pathways. The study aims to investigate whether this combined approach may help overcome limitations associated with single-pathway inhibition. This is a single-center, interventional ex vivo study conducted at IRCCS Ospedale San Raffaele. The study includes 30 participants divided into three cohorts: 10 patients with Ulcerative Colitis, 10 patients with Crohn's Disease, and 10 non-IBD control participants. Participant involvement is limited to a single day and is integrated into a clinically indicated, routinely scheduled colonoscopy and routine phlebotomy. During the scheduled colonoscopy, 8 additional mucosal biopsies are collected for research purposes, together with an additional 2 mL blood sample. No additional endoscopic procedure or separate study visit is required. No investigational drug or treatment is administered directly to participants. The collected intestinal biopsies are instead treated ex vivo in the laboratory with ATTO-1091, individual pathway inhibitors, or control conditions for 16 hours. Biological and molecular responses are evaluated using laboratory techniques including ELISA and RNA sequencing to assess inflammatory markers and gene expression. Laboratory personnel performing molecular and transcriptomic analyses are blinded to participants' clinical profiles until final data analysis.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 4 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- PhoenixLAB srls
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07824726
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Oct 2026 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patients of at least 18 years of age unable to comply with the study procedures and to sign an informed consent form
Other
- Absolute contraindications to colonoscopy procedures
- UC or CD patients in endoscopic remission
- IBS or patients undergoing CRC prevention surveillance with inflamed mucosa during the endoscopy
- Pregnancy or breastfeeding
Who the study is looking for
- Patients of at least 18 years of age
- Able to comply with the study procedures and to sign an informed consent form
- Established diagnosis of UC or CD, with indication to start any biological or small molecule agents as per standard of care:
- UC patients with a clinical indication to start biologics or small molecules as per standard of care, with a Total Mayo Score of 6-12 (moderate-severe disease) and an endoscopic subscore ≥ 2; CD patients with a clinical indication to start biologics or small molecules as per standard of care, with a clinical CDAI score of 220-600 (moderate-severe disease) and endoscopic evidence of active mucosal inflammation/ulceration upon baseline examination;
- \- Patients with IBS or individuals undergoing colonoscopy for CRC prevention or routine surveillance, with no prior diagnosis of inflammatory bowel disease and no endoscopic evidence of intestinal mucosal inflammation.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.