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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 medication called Guselkumab in individuals with Moderately to Severely Active Ulcerative Colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine, leading to symptoms like abdominal pain and diarrhea. The medication being tested, Guselkumab, is a type of treatment known as a monoclonal antibody, which is administered through an injection or infusion. It is designed to target specific proteins in the body to help reduce inflammation.

The purpose of this study is to evaluate how effective and safe Guselkumab is for people with this condition. Participants in the study will receive either Guselkumab or a placebo, which is a substance with no active medication. The study will follow a structured plan where participants will receive the treatment over a period of time, and their health will be monitored to assess the medication's impact on their ulcerative colitis symptoms.

Throughout the study, participants will undergo regular check-ups to track their progress and any changes in their condition. The goal is to determine if Guselkumab can provide relief from the symptoms of ulcerative colitis and improve the quality of life for those affected by this disease. The study is designed to ensure the safety and well-being of all participants while gathering important information about the potential benefits of this treatment.

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, eligibility is confirmed based on criteria such as age, diagnosis of ulcerative colitis for at least 3 months, and previous treatment history.

    Initial assessments include a review of medical history and laboratory tests to ensure all parameters meet the study requirements.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of guselkumab, a medication provided as a solution for injection in a pre-filled syringe.

    The medication is administered through subcutaneous use, which means it is injected under the skin.

  3. Step 3

    Treatment schedule

    The dosage of guselkumab is 100 mg/mL. The frequency and duration of administration are determined by the study protocol.

    Participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual medication.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to evaluate the efficacy and safety of the treatment. This includes clinical assessments and laboratory tests.

    The primary goal is to achieve a clinical response by Induction Week 12.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 9, 2027.

    Final assessments are conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

5 criteria

  • Must be a male or female who is 18 years of age or older.
  • Must have a documented diagnosis of Ulcerative Colitis (UC) for at least 3 months before the screening. Ulcerative Colitis is a condition that causes inflammation and sores in the colon.
  • Must have moderately to severely active UC, which is determined by a specific scoring system called the modified Mayo score. This score helps to measure the severity of the condition.
  • Must have a history of not responding well to or not being able to tolerate standard or advanced treatments as defined in the study protocol. This means previous treatments did not work well or caused side effects that were hard to handle.
  • Must have laboratory test results during screening that are within the limits set by the study protocol. This means certain blood tests and other tests must show results that are acceptable for the study.

Who cannot join the trial?

9 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics or other medications.
  • Patients who have received certain vaccines within a specific time frame before the study.
  • Patients who have a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have certain allergies or reactions to the study medication.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Guselkumab is a medication being studied for its effectiveness and safety in treating people with moderately to severely active ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the digestive tract. This medication works by targeting specific proteins in the body that are involved in the inflammatory process, potentially reducing symptoms and improving the quality of life for patients with this condition.

What is already known about the treatment

Guselkumab – Guselkumab is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active ulcerative colitis. It is a monoclonal antibody that targets interleukin-23 (IL-23), a protein involved in inflammatory processes. By inhibiting IL-23, guselkumab helps reduce inflammation in the colon, which is beneficial for patients with ulcerative colitis. It is classified as an immunosuppressive agent and is already approved for other inflammatory conditions, but its use in ulcerative colitis is still under investigation.

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 IVTrial ID2023-504718-31-00Protocol codeCNTO1959UCO3001Estimated enrolment1 471 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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