Recruiting

Study on Reducing Vedolizumab Dosage for Patients with Inflammatory Bowel Disease

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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 Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's Disease and Ulcerative Colitis. These are chronic conditions that cause inflammation in the digestive tract. The treatment being studied is a medication called vedolizumab, which is given as a solution for injection. Vedolizumab is also known by its code names MLN0002 and PB016. The purpose of the study is to evaluate the effectiveness of reducing the dose of vedolizumab given under the skin (subcutaneously) to patients who are in remission, meaning their symptoms are not currently active.

Participants in the study will have been receiving vedolizumab every two weeks for at least six months and will be in a state of remission without the use of steroids. The study will explore whether it is possible to extend the time between doses without causing a relapse, which is when symptoms return. The trial will also look at various factors, such as the need for additional treatments like corticosteroids, the number of emergency visits, hospitalizations, surgeries, and any changes in the quality of life of the participants. Additionally, the study will assess the cost-effectiveness of extending the interval between doses and monitor any side effects that may occur.

The trial is expected to run for a period of time, with the recruitment of participants starting in early 2025 and the study concluding by the end of August 2026. The findings from this study could provide valuable insights into managing IBD more effectively and potentially improving the quality of life for those affected by these conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the eligibility criteria. This includes being an adult diagnosed with Crohn's Disease or Ulcerative Colitis, currently in steroid-free remission, and having been treated with bi-weekly subcutaneous vedolizumab for at least six months.
Step 2
Initial assessment
An initial assessment is conducted to confirm the current health status and remission of the disease. This may involve clinical evaluations and laboratory tests.
Step 3
Treatment phase
The treatment involves the administration of Entyvio 108 mg solution for injection, which contains the active substance vedolizumab. The medication is given as a subcutaneous injection.
The study aims to evaluate the effectiveness of reducing the frequency of vedolizumab doses. The specific schedule for dose de-escalation will be determined based on the study protocol.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the dose de-escalation. This includes tracking any changes in disease activity, the need for additional treatments, and any adverse events.
Follow-up visits may include clinical evaluations, laboratory tests, and questionnaires to assess quality of life and other health outcomes.
Step 5
Completion of the study
The study is expected to conclude by August 31, 2026. Upon completion, a final assessment will be conducted to evaluate the overall outcomes of the treatment and any long-term effects.

Who can join the trial?

5 criteria

Participants must be adults, which means they are 18 years or older.
Participants should have been diagnosed with either Crohn's Disease or Ulcerative Colitis. These are types of Inflammatory Bowel Disease, which is a condition that causes inflammation in the digestive tract.
Participants must be in steroid-free clinical and biochemical remission. This means their disease is under control without the use of steroid medications, and tests show no signs of active inflammation.
Participants should have been treated with subcutaneous vedolizumab every two weeks for at least six months. Subcutaneous means the medication is given as an injection under the skin, and vedolizumab is a drug used to treat inflammatory bowel diseases.
Both male and female participants are eligible to join the study.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients who have a history of severe allergic reactions to medications.
Patients who have a history of drug or alcohol abuse.
Patients who have an active infection that requires treatment.
Patients who have been diagnosed with cancer in the past five years.
Patients who have a history of heart disease or uncontrolled high blood pressure.
Patients who have a history of liver or kidney disease.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
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Leiden, The Netherlands
Stichting Radboud University Medical Center
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Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Vedolizumab is a medication used in this trial to treat inflammatory bowel disease. It works by blocking certain proteins in the body that can cause inflammation in the gut. In this study, the focus is on reducing the dosage of vedolizumab to see if it remains effective in managing the disease while potentially minimizing side effects.

Vedolizumab

What is already known about the treatment

Vedolizumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating inflammatory bowel disease (IBD). Vedolizumab is primarily used to manage conditions like ulcerative colitis and Crohn's disease. It works by blocking a specific protein that causes inflammation in the gut, helping to reduce symptoms and maintain remission. Vedolizumab is classified as a monoclonal antibody, which targets specific molecules in the immune system to prevent inflammation.

Investigated diseases

Inflammatory Bowel Disease – This term refers to a group of disorders that cause chronic inflammation in the digestive tract. The two main types are Crohn's disease and ulcerative colitis. Inflammatory bowel disease often involves periods of active symptoms, known as flare-ups, and periods of remission, where symptoms may decrease or disappear. Symptoms can include abdominal pain, diarrhea, weight loss, and fatigue. The exact cause is unknown, but it is believed to involve an immune system malfunction. Over time, the inflammation can lead to complications such as bowel obstruction or malnutrition.