Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease
Not applicable · Testing Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy… · 1 site · PhoenixLAB srls
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing (a procedure) and Collection of an additional 2 mL blood sample (a procedure) to better understand how the disease works. Condition(s) listed: Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease) and Crohn Disease (CD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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:
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2026-10-01 (planned).
- Main results expected around 2026-10-01 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- Concentration of pro-inflammatory cytokines in intestinal biopsy culture supernatants following ex vivo treatment with ATTO-1091 (16 hours after ex vivo exposure)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease); Crohn Disease (CD) |
| Lead sponsor | PhoenixLAB srls |
| Collaborators | IRCCS San Raffaele |
| Enrollment | 30 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2026-10-01 |
| First posted | 2026-09-17 |
| Last updated | 2026-09-17 |
| Official title | Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07824726 |
Interventions
- Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing (Procedure)
Eight additional mucosal biopsies will be collected during a clinically indicated, scheduled standard-of-care colonoscopy. Biopsies will be obtained according to a standardized sampling protocol, with the anatomical site of each biopsy documented. The additional biopsies are collected for research purposes and subsequently processed for ex vivo laboratory analyses. No investigational product is ad… - Collection of an additional 2 mL blood sample (Procedure)
An additional 2 mL blood sample will be collected during routine phlebotomy performed in conjunction with the scheduled study visit. The additional blood collection is performed for research purposes and does not require a separate study visit.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patients of at least 18 years of age unable to comply with the study procedures and to sign an informed consent form * Pregnancy or breastfeeding
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele | Milan, MI | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.