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Study Comparing Vedolizumab and Adalimumab for Crohn's Disease Patients Who No Longer Respond to Adalimumab

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Crohn's disease, a chronic inflammatory condition of the digestive tract. The study compares two treatments: Vedolizumab and Adalimumab. Vedolizumab is administered as a solution for infusion, while Adalimumab is given as a solution for injection. The purpose of the study is to evaluate the effectiveness of Vedolizumab compared to an increased dose of Adalimumab in patients who have lost their initial response to Adalimumab or have high levels of certain biomarkers, which are substances in the body that can indicate disease activity.

Participants in the study will be randomly assigned to receive either Vedolizumab or an increased dose of Adalimumab. The study will last for up to 52 weeks, with the main evaluation occurring at 24 weeks. During this time, the study will monitor the participants' response to the treatment, looking for signs of remission, which means a reduction or disappearance of symptoms. The study will also track any side effects and overall health improvements.

The trial aims to provide insights into which treatment strategy is more effective for patients with Crohn's disease who have not responded well to standard doses of Adalimumab. By comparing these two approaches, the study hopes to improve treatment options and outcomes for individuals living with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, consent is required to participate. This involves understanding the purpose of the trial and agreeing to the procedures involved.

    Eligibility is confirmed based on having Crohn's disease and a previous response to Adalimumab treatment, with a loss of response or high biomarker activity.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate current health status and establish baseline measurements. This may include blood tests and other diagnostic procedures.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups: one group will receive Vedolizumab treatment, and the other will have an increased dose of Adalimumab.

  4. Step 4

    Treatment phase

    For those receiving Vedolizumab, the medication is administered as a solution for infusion. The specific dosage and frequency will be determined by the study protocol.

    Participants in the Adalimumab group will receive a higher dose than the standard 40 mg every two weeks. The exact dosage will be adjusted according to the study requirements.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and any side effects. This includes clinical evaluations and biomarker tests.

    Follow-up visits are scheduled at specific intervals, such as at 12 weeks, 24 weeks, and 52 weeks, to evaluate progress and make necessary adjustments to the treatment plan.

  6. Step 6

    Final assessment

    At the end of the study period, a final assessment is conducted to determine the overall effectiveness of the treatment. This includes evaluating clinical remission and biomarker levels.

Who can join the trial?

5 criteria

  • The patient must be an adult and must have given consent to participate in the study.
  • The patient must have Crohn's disease and have previously responded to a medication called Adalimumab or a similar drug. However, the patient must now have a reduced response to Adalimumab (40 mg every two weeks) and/or show high activity of disease markers in the blood, even though the drug levels are adequate (more than 7.5 micrograms per milliliter).
  • The patient must be affiliated with or entitled to a social security scheme.
  • Both male and female patients can participate.
  • The study is open to patients who are not considered part of a vulnerable population.

Who cannot join the trial?

5 criteria

  • Patients who do not have **Crohn's disease** cannot participate.
  • Patients who are not experiencing a **loss of secondary response** to their current treatment cannot participate. This means their current treatment is still working well for them.
  • Patients who do not have **high biomarker activity** cannot participate. Biomarkers are substances in the body that can indicate how active the disease is.
  • Patients who are not on a **standard-dose Adalimumab maintenance therapy** cannot participate. Adalimumab is a medication used to treat Crohn's disease.
  • Patients who do not have **therapeutic drug levels** cannot participate. This means the amount of medication in their body is not at the right level to be effective.
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Investigated drugs

  • Vedolizumab

    is a medication used to treat Crohn's disease, which is a condition that causes inflammation in the digestive tract. This medication works by blocking a specific protein in the body that causes inflammation. By doing this, Vedolizumab helps to reduce the symptoms of Crohn's disease, such as stomach pain and diarrhea, and can help patients achieve remission, meaning their symptoms are reduced or disappear.

  • Adalimumab

    is another medication used to treat Crohn's disease. It is a type of drug known as a biologic, which means it is made from living cells. Adalimumab works by blocking a protein in the body that causes inflammation, helping to reduce the symptoms of Crohn's disease. In this trial, the focus is on adjusting the dose of Adalimumab to see if it can help patients who have stopped responding to the standard dose or have high levels of inflammation markers in their blood.

What is already known about the treatment

  • Vedolizumab

    Vedolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently used in medicine to treat Crohn's disease, especially in patients who have not responded well to other treatments. The main therapeutic indication for Vedolizumab is to help reduce inflammation in the digestive tract, which is a key problem in Crohn's disease. At the molecular level, Vedolizumab works by blocking a specific protein that causes white blood cells to move into the gut, thereby reducing inflammation. It is classified as a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

  • Adalimumab

    Adalimumab is typically administered as an injection under the skin, which patients can often do themselves at home. It is widely used in medicine to treat Crohn's disease and other inflammatory conditions. The main therapeutic indication for Adalimumab is to reduce inflammation and help manage symptoms in patients with Crohn's disease. At the molecular level, Adalimumab works by blocking a protein called tumor necrosis factor (TNF), which plays a role in causing inflammation. It is classified as a TNF inhibitor, a type of medication that helps control inflammation in the body.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications like strictures or fistulas. Over time, the disease can cause damage to the digestive tract, potentially leading to further complications. The progression of Crohn's disease varies among individuals, with some experiencing frequent flare-ups and others having long periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508154-25-00Protocol code23CH214Estimated enrolment220 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).