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Triple-Pronged attack on gut inflammation put to the test

NCT ID NCT07824726

Knowledge-focused Sponsor: PhoenixLAB srls Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether blocking three inflammation pathways at once (TL1A, IL-23, and α4β7) calms inflamed intestinal tissue more effectively than blocking each pathway alone. The study enrolls 30 people: 10 with ulcerative colitis, 10 with Crohn's disease, and 10 without IBD. During a routine colonoscopy, doctors collect eight extra tissue samples and a small blood sample. In the lab, they treat the tissue with the three-pathway combination, single-pathway inhibitors, or a control, then measure inflammatory markers and gene activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATTO-1091, an experimental combination that blocks three inflammation pathways (TL1A, IL-23, and α4β7), tested on intestinal biopsies in the laboratory
What this could lead to
If the combination calms inflamed gut tissue more than single-pathway drugs, it could point toward a new treatment strategy for ulcerative colitis and Crohn's disease.
What could go wrong
This is a small laboratory study of 30 people, and tissue tested outside the body may not behave the same way inside a patient. The results may not translate into a working treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) IBD (inflammatory bowel disease) Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS San Raffaele

    Milan, MI, 20131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.