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Study on the Effectiveness and Safety of Guselkumab for Patients with Moderate to Severe Ulcerative Colitis

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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 effects of a treatment for ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The treatment being tested is called guselkumab, which is a type of medication known as a monoclonal antibody. This medication is given as an injection under the skin using a pre-filled syringe. The study also includes a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how effective and safe guselkumab is for people with moderately to severely active ulcerative colitis. Participants in the study will receive either the medication or a placebo. The study will last for a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment.

Throughout the study, researchers will assess whether participants achieve clinical remission, which means a significant reduction or disappearance of symptoms. The study aims to provide valuable information about the potential benefits of guselkumab for individuals living with ulcerative colitis.

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

    Joining the study

    Upon joining the study, the participant will be assessed to confirm a documented diagnosis of ulcerative colitis for at least 3 months prior to the baseline.

    The participant must have moderately to severely active ulcerative colitis as assessed by the modified mayo score.

    The participant must have demonstrated an inadequate response to or intolerance of conventional therapies or advanced therapies.

  2. Step 2

    Treatment initiation

    The participant will begin treatment with guselkumab, administered as a subcutaneous injection.

    The medication is provided in a pre-filled syringe with a concentration of 100 mg/mL.

    The treatment aims to evaluate the efficacy of guselkumab in achieving clinical remission by week 12.

  3. Step 3

    Treatment administration

    The participant will receive the guselkumab injection according to the study protocol.

    The frequency and dosage will be determined by the study guidelines and monitored by the study team.

  4. Step 4

    Monitoring and assessment

    Throughout the study, the participant's health and response to the treatment will be regularly monitored.

    Assessments will focus on the participant's progress towards clinical remission and any side effects experienced.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 4, 2025.

    Upon completion, the participant's overall response to the treatment will be evaluated to determine the efficacy and safety of guselkumab for ulcerative colitis.

Who can join the trial?

5 criteria

  • You must have a documented diagnosis of ulcerative colitis (UC) for at least 3 months before starting the study. Ulcerative colitis is a condition that causes inflammation and sores in the colon.
  • Your UC must be moderately to severely active, which is determined by a specific scoring system called the modified Mayo score. This score helps doctors understand how active your UC is.
  • You must have shown an inadequate response to or intolerance of conventional treatments or advanced therapies. Conventional treatments include medications like 6-MP, AZA, or corticosteroids. Advanced therapies include medications like TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors. This means that these treatments did not work well for you or you could not tolerate them.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from a vulnerable population, which means it considers people who might need extra care or protection.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat people with moderately to severely active ulcerative colitis. It is given as an injection under the skin. The goal of using guselkumab in this study is to see how well it works in helping patients achieve clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis.

What is already known about the treatment

Guselkumab – This medication is administered through subcutaneous injection. It is currently being studied in clinical trials for its effectiveness in treating moderate to severely active ulcerative colitis. The main therapeutic indication is to achieve clinical remission in patients with this condition. Guselkumab works by targeting and inhibiting a specific protein in the immune system, which helps reduce inflammation. It is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific pathways in the immune response.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504719-34-00Protocol codeCNTO1959UCO3004Estimated enrolment317 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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