Combined inflammation blockers tested on gut tissue from inflammatory bowel disease
Tests combined inflammation blockers on gut samples in inflammatory bowel disease.
Key facts
- Who runs it
- PhoenixLAB srls
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease
- Status
- Not yet recruiting
- People taking part
- 30 people, planned
- Started
- 1 Oct 2026
- Planned end
- 1 Oct 2026
- Type of study
- Interventional, 3 groups
- Treatments tested
- Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing
- Collection of an additional 2 mL blood sample
- Record updated
- 17 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are about to start a biologic or small molecule drug. It also takes adults without IBD and with a calm gut lining as controls.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis: Total Mayo Score of 6-12 and endoscopic subscore of 2 or more. Crohn's disease: CDAI score of 220-600 and active inflammation or ulcers seen at colonoscopy. Controls: IBS or colonoscopy for colorectal cancer prevention or routine checks, with no IBD and no inflammation seen.
- Earlier treatment
- Ulcerative colitis and Crohn's disease patients must have a standard-of-care reason to start a biologic or small molecule drug.
Main reasons for not taking part
- Cannot have a colonoscopy for safety reasons
- Ulcerative colitis or Crohn's disease in endoscopic remission
- IBS or surveillance patients with inflamed gut lining at colonoscopy
- Unable to follow the study steps or sign consent
- Pregnant or breastfeeding
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients of at least 18 years of age unable to comply with the study procedures and to sign an informed consent form
- 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
Where in Italy
- IRCCS San RaffaeleMilan, ItalyContact: Federica Ungaro, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Control group - NO IBDOther group
Non-IBD control cohort consisting of individuals without inflammatory bowel disease undergoing scheduled standard-of-care colonoscopy. During the procedure, 8 additional mucosal biopsies and 2 mL of blood are collected. Collected mucosal tissue is cultured ex vivo for 16 hours with the tri-specific inhibitor ATTO-1091, individual monotherapies (tulisokibart, risankizumab, vedolizumab), or vehicle control to evaluate baseline non-inflamed mucosal responses.
Treatment: Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing and Collection of an additional 2 mL blood sample
- Crohn's Disease (CD)Other group
Crohn's Disease (CD) cohort consisting of individuals with confirmed CD undergoing scheduled standard-of-care colonoscopy. During the procedure, 8 additional mucosal biopsies and 2 mL of blood are collected. Collected mucosal tissue is cultured ex vivo for 16 hours with the tri-specific inhibitor ATTO-1091, individual monotherapies (tulisokibart, risankizumab, vedolizumab), or vehicle control to evaluate mucosal responses in CD tissue.
Treatment: Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing and Collection of an additional 2 mL blood sample
- Ulcerative Colitis (UC)Other group
Ulcerative Colitis (UC) cohort consisting of individuals with confirmed UC undergoing scheduled standard-of-care colonoscopy. During the procedure, 8 additional mucosal biopsies and 2 mL of blood are collected. Collected mucosal tissue is cultured ex vivo for 16 hours with the tri-specific inhibitor ATTO-1091, individual monotherapies (tulisokibart, risankizumab, vedolizumab), or vehicle control to evaluate mucosal responses in UC tissue.
Treatment: Collection of 8 additional intestinal mucosal biopsies during standard-of-care endoscopy for subsequent ex vivo testing and Collection of an additional 2 mL blood sample
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease
- Plain-language title
- Combined inflammation blockers tested on gut tissue from inflammatory bowel diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 17 September 2026