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Study on the Effectiveness and Safety of PB016 and Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis

Fast replyRegistered 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 a condition called ulcerative colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study is comparing two treatments: an investigational treatment known as PB016 and a licensed treatment called Entyvio. Both treatments involve the use of a substance called vedolizumab, which is a type of protein designed to help reduce inflammation in the gut.

The purpose of the study is to evaluate how well PB016 works and how safe it is compared to Entyvio in people with moderately to severely active ulcerative colitis. Participants in the study will receive one of these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 46 weeks, during which participants will be monitored to see how their condition responds to the treatment. The study will also look at the safety of the treatments and any potential side effects.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. This includes monitoring changes in symptoms and any improvements in their condition. The study aims to provide valuable information on the potential benefits and risks of using PB016 compared to Entyvio for treating ulcerative colitis, helping to improve future treatment options for this condition.

The research process

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

  1. Step 1

    Initial visit and randomization

    Upon joining the study, participants will attend an initial visit where eligibility is confirmed. This includes a review of medical history and current medications.

    Participants will be randomly assigned to receive either the investigational treatment PB016 or the licensed treatment Entyvio®.

  2. Step 2

    Treatment administration

    Participants will receive the assigned treatment through an intravenous (IV) infusion. This involves administering the medication directly into a vein.

    The treatment consists of vedolizumab, administered as a 300 mg dose in the form of a solution for infusion.

  3. Step 3

    Induction phase

    The initial phase of the study, known as the induction phase, lasts for 6 weeks. During this time, the effectiveness of the treatment in reducing symptoms will be evaluated.

    Participants will have regular check-ups to monitor their response to the treatment and any side effects.

  4. Step 4

    Maintenance phase

    Following the induction phase, participants who respond to the treatment will enter the maintenance phase, which continues up to 52 weeks.

    During this phase, the ongoing effectiveness and safety of the treatment will be assessed through regular visits and evaluations.

  5. Step 5

    End of study

    At the end of the study period, participants will have a final evaluation to assess the overall impact of the treatment on their condition.

    Participants will be informed about the results of the study and any further steps regarding their treatment.

Who can join the trial?

12 criteria

  • Age between 18 and 80 years at the time of screening.
  • Females who can have children must not be pregnant or breastfeeding. They should either be unable to have children or use highly effective birth control methods.
  • Male participants who are sexually active with women who can have children must use highly effective birth control methods and must not donate sperm for 30 days after the last dose of the study drug.
  • Must have been diagnosed with moderate to severe ulcerative colitis (UC) at least 6 months before screening. This diagnosis should be confirmed by medical tests and a doctor.
  • Must have active UC with a specific score (Mayo score of 6 to 12) and a certain level of inflammation in the colon, confirmed by a central reader within 28 days before starting the study.
  • Must have UC that affects more than 15 cm of the colon beyond the rectum.
  • If you have extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, you must have had a colonoscopy within 12 months before the initial screening visit.
  • If you have a family history of colorectal cancer, personal risk factors, are over 45 years old, or have other known risk factors, you must be up-to-date with colorectal cancer screenings.
  • Must have shown an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunomodulators, or Tumor Necrosis Factor alpha (TNFα) antagonists.
  • May be taking certain medications, such as oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, probiotics, antidiarrheals, azathioprine, or 6-mercaptopurine, as long as the dose has been stable for a specified period before starting the study.
  • Must be able to participate in all aspects of the clinical study.
  • Must voluntarily agree to participate and provide informed consent.

Who cannot join the trial?

15 criteria

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients who have a history of severe allergic reactions to any medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years, except for certain skin cancers.
  • Patients who have had a major surgery within the last 12 weeks.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of liver disease.
  • Patients who have a history of kidney disease.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of blood disorders.
  • Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who are currently taking medications that could interfere with the study.
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Investigated drugs

  • PB016

    is an experimental medication being tested in this clinical trial. It is designed to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. The goal of this medication is to reduce the symptoms of ulcerative colitis, such as abdominal pain and diarrhea, and help patients achieve remission, which means the symptoms are reduced or disappear.

  • Entyvio®

    is a medication already used to treat ulcerative colitis. It works by targeting specific proteins in the body to reduce inflammation in the colon. This medication is used to help patients with ulcerative colitis feel better by decreasing symptoms and helping them maintain remission over time. In this trial, Entyvio® is being compared to PB016 to see if they have similar effects on patients with ulcerative colitis.

What is already known about the treatment

  • PB016

    PB016 is administered through an intravenous (IV) infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. The medication works by targeting specific proteins in the immune system to reduce inflammation and help achieve remission of symptoms. PB016 is classified as a biologic therapy, which means it is made from living organisms or their cells.

  • Entyvio®

    Entyvio® is also given as an intravenous (IV) infusion, allowing the medication to enter the bloodstream directly. It is an established treatment for ulcerative colitis, a chronic inflammatory bowel disease. Entyvio® works by blocking a specific protein that causes inflammation in the gut, helping to reduce symptoms and maintain remission. It belongs to a class of drugs known as integrin receptor antagonists, which are designed to target and block certain pathways in the immune system.

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 the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements. Over time, the disease can lead to complications such as severe bleeding or perforation of the colon.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502778-18-00Protocol codePB016-03-01Estimated enrolment1 054 patientsSponsorPolpharma Biologics S.A.

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