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Crohn's patients: switch drug or up dose? new trial seeks answers

NCT ID NCT06180382

Disease control Sponsor: Centre Hospitalier Universitaire de Saint Etienne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 220 adults with Crohn's disease whose symptoms returned while on adalimumab. Half will get a higher dose of adalimumab, and the other half will switch to vedolizumab. The goal is to see which approach leads to better control of the disease after 24 weeks, using both symptoms and lab tests.

What this could mean

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

Active substance
vedolizumab and adalimumab
What this could lead to
If it works, this could show that switching to vedolizumab is a better option than simply increasing the dose of adalimumab for Crohn's patients who have stopped responding.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but it is still unclear which strategy works best. Results may not apply to all patients, and both drugs carry risks like infection or allergic reactions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 220 people

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

Started

Oct 2024

Expected to finish

Oct 2028

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: * Major patient and having given consent to participate in the study * Patients with Crohn's disease who have responded primary to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks). * Patient affiliated to or entitled under a social security scheme Exclusion Criteria: * Pregnant woman * Patient unable to perform MRI or VCE or ileocolonoscopy or ultrasound less than one month before inclusion * Previous or current use of vedolizumab or ustekinumab for Crohn's disease or participation in a biological study * Concomitant use of immunomodulators * Patients on corticosteroid therapy * History of cancer * History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections * Patient with ileoanal pouchitis or ileorectal anastomosis * Patient with short small bowel syndrome as determined by investigator * Patients receiving total parenteral nutrition (TPN) * Patients receiving enteral nutrition * Patient under legal protection or unable to give consent * Hemorrhagic rectocolitis or indeterminate colitis * Patients treated with concomitant immunosuppressive agents * Patient treated with an optimized dose of adalimumab * Primary non-responder to Adalimumab * Patient previously treated with infliximab or ustekinumab before adalimumab * Severe relapse defined by CDAI \> 330 * Patient with anoperineal Crohn's disease * Crohn's disease patient with transient or permanent stoma.

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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's disease

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

  • APHM

    RECRUITING

    Marseille, 13000, France

  • APHP - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, PARIS, 94270, France

  • Assistance Publique - Hôpitaux de Paris

    RECRUITING

    Paris, 75004, France

  • CHRU Lille

    RECRUITING

    Lille, 59037, France

  • CHU Amiens

    RECRUITING

    Amiens, 80000, France

  • CHU Bordeaux

    RECRUITING

    Pessac, 33604, France

  • CHU Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU de Saint-Etienne

    RECRUITING

    Saint-Etienne, 42055, France

  • Ch Lyon Sud

    RECRUITING

    Pierre-Bénite, 69230, France

  • Chu Limoges

    RECRUITING

    Limoges, 87000, France

  • Hôpital de l'Archet II

    RECRUITING

    Nice, 06202, France

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