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Study on Vedolizumab for Patients with Active Ulcerative Colitis

Verified siteRegistered drugNo placebo
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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 ulcerative colitis, a condition that causes inflammation and sores in the lining of the large intestine. The trial will explore the effectiveness of a treatment using a medication called vedolizumab. Vedolizumab is available in two forms: a 300 mg powder that is mixed into a solution and given through an intravenous infusion, and a 108 mg solution that is injected using a pre-filled syringe.

The purpose of the study is to determine the best treatment target for people with moderately to severely active ulcerative colitis. Participants will be divided into groups to receive different treatment targets. The study will compare whether aiming for a more comprehensive remission, which includes being free from symptoms, endoscopic signs, and histological signs without the use of corticosteroids, is better than just aiming for symptom relief without corticosteroids. The study will follow participants for up to 80 weeks after they achieve their treatment target to see if there are any complications related to ulcerative colitis.

Throughout the study, participants will receive regular assessments to monitor their progress and any changes in their condition. The trial will also look at various health indicators, such as levels of certain proteins in the blood and stool, to understand the effects of the treatment. The goal is to find the most effective way to manage ulcerative colitis and improve the quality of life for those affected by this 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, the participant will be required to provide written informed consent. This confirms understanding and agreement to participate in the trial.

    Eligibility will be confirmed based on criteria such as age, diagnosis of ulcerative colitis, and other health assessments.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the current state of ulcerative colitis. This includes clinical, endoscopic, and histological evaluations.

    Tests for tuberculosis and hepatitis B and C will be performed if recent results are not available.

  3. Step 3

    Treatment administration

    Participants will receive vedolizumab, a medication used to treat ulcerative colitis.

    The medication will be administered in two forms: intravenous infusion of Entyvio 300 mg and subcutaneous injection of Entyvio 108 mg.

    The frequency and duration of administration will be determined by the study protocol and the participant's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored regularly to assess the effectiveness of the treatment and any side effects.

    Assessments will include changes in symptoms, endoscopic findings, and histological evaluations at specified intervals up to 96 weeks.

    Regular blood tests and other evaluations will be conducted to monitor health and response to treatment.

  5. Step 5

    Evaluation of treatment targets

    The trial aims to achieve specific treatment targets, such as corticosteroid-free symptomatic remission and endoscopic remission.

    Participants will be evaluated to determine if these targets are met, and adjustments to treatment may be made based on these evaluations.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until April 2026, with participants followed for up to 80 weeks after achieving treatment targets.

    Upon completion, participants will undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

10 criteria

  • You must be **18 years or older**.
  • You need to be **up to date with colorectal cancer checks** according to local guidelines. If not, you can have this check during the screening period.
  • You must have a **diagnosis of ulcerative colitis (UC)** confirmed by medical tests before the screening.
  • Your UC should be **moderately to severely active**, with specific scores on medical tests and a minimum affected area of 15 cm that can be seen using a special camera system.
  • You should be able to **participate fully** in all parts of the clinical trial.
  • You need to **provide written informed consent**, which means you agree to participate after understanding the trial details.
  • You must agree **not to join another investigation trial** during this study. However, some non-interventional trials might be allowed.
  • You need to have a **negative test for tuberculosis (TB)** and **hepatitis B and C** before starting the trial, unless you have negative results from the past 12 months.
  • If you are a **non-sterilized male** and sexually active with a female partner who can have children, you must agree to use **adequate contraception** from the time you sign the consent until 18 weeks after the last dose.
  • If you are a **female who can have children** and sexually active with a non-sterilized male partner, you must agree to use **adequate contraception** from the time you sign the consent until 18 weeks after the last dose.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery related to their ulcerative colitis.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of not responding to similar treatments in the past.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication.
  • 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.
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Investigated drugs

  • Corticosteroids

    are medications used to reduce inflammation in the body. In this trial, they are used to help manage symptoms of ulcerative colitis by reducing inflammation in the colon. The goal is to achieve remission without the need for ongoing corticosteroid use.

  • Symptomatic Treatment

    involves using medications or therapies to relieve the symptoms of ulcerative colitis, such as abdominal pain and diarrhea, without necessarily addressing the underlying inflammation.

  • Endoscopic Treatment

    refers to therapies aimed at improving the appearance of the colon lining as seen through an endoscope. This is used to assess and treat the inflammation and damage caused by ulcerative colitis.

  • Histological Treatment

    involves targeting the microscopic inflammation in the colon tissue. This approach aims to achieve remission by ensuring that the tissue appears normal under a microscope, indicating that the inflammation has been effectively treated.

What is already known about the treatment

Mesalamine – Mesalamine is typically administered orally in the form of tablets or capsules, and it can also be applied rectally as a suppository or enema. It is widely recognized in medical literature as a treatment for ulcerative colitis, a chronic inflammatory bowel disease. The main therapeutic indication for mesalamine is to reduce inflammation in the colon, helping to achieve and maintain remission in patients with ulcerative colitis. At the molecular level, mesalamine works by inhibiting the production of certain chemicals in the colon that cause inflammation. It is classified pharmacologically as an anti-inflammatory agent, specifically a 5-aminosalicylic acid derivative.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission, where symptoms may worsen and then improve. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to complications if not managed. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in genetically predisposed individuals. Environmental factors and gut microbiota may also play a role in its development and progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514183-21-00Protocol codeRP1706Estimated enrolment672 patientsSponsorAlimentiv Inc.

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