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New drug aims to prevent Crohn's relapse after surgery

NCT ID NCT06925061

Prevention Sponsor: Madeleine Bezault Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests an oral drug called EXL01 to see if it can prevent Crohn's disease from coming back after bowel surgery. About 80 adults who recently had surgery for Crohn's will receive either EXL01 or a placebo for up to 24 weeks. Doctors will use a camera to check the bowel for signs of disease at 6 months after surgery.

What this could mean

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

Active substance
EXL01 (an oral drug)
What this could lead to
If it works, this could point toward a new way to prevent Crohn's disease from coming back after surgery.
What could go wrong
This is an early Phase 2 trial with only 80 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

Mar 2025

Expected to finish

Dec 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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Is male or female aged ≥18 years at the time of providing documented informed consent. * Has a diagnosis of CD with ileal involvement (ileal only or ileocolonic; L1 or L3 in Montreal classification) for at least 3 months prior to Screening. * Has undergone an ileocecal resection or iterative ileo-colonic resection, as per institutional SoC, between 5 days to 5 weeks before randomization. * Is scheduled, in SoC context, to receive no treatment for CD or anti-TNF agents in the 6 months after surgery Exclusion Criteria: * Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention * Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration) * Has active anal fistula * Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery * Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm * Has a contraindication to endoscopy or anaesthesia. * Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo. * Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products. * Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention * Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration) * Has active anal fistula * Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery * Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm * Has a contraindication to endoscopy or anaesthesia. * Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo. * Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn disease (CD)

How to take part

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

  1. The places running it

    12 sites. 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

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU Marseille Nord

    RECRUITING

    Marseille, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • CHU Nancy

    RECRUITING

    Nancy, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Nice Archet 2

    RECRUITING

    Nice, France

  • CHU Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospices civils Lyon Sud

    RECRUITING

    Lyon, France

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Henri Mondor

    RECRUITING

    Créteil, France

  • Hôpital Saint Antoine

    RECRUITING

    Paris, 75012, France

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