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Study on the Effectiveness and Safety of Guselkumab for Children 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 children and teenagers with a condition known as Ulcerative Colitis. Ulcerative Colitis is a disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The medication being tested, Guselkumab, is a type of treatment known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can help the immune system fight diseases.

The purpose of this study is to evaluate how effective and safe Guselkumab is for young patients with moderately to severely active Ulcerative Colitis. The study will involve an initial phase where participants receive the treatment openly, followed by a phase where neither the participants nor the researchers know who is receiving Guselkumab and who is receiving a placebo. This helps ensure that the results are not biased. The study will last for a period of time, during which participants will receive the treatment and be monitored for any changes in their condition.

Participants in the study will receive Guselkumab through injections, either under the skin or into a vein, depending on the specific formulation used. The study aims to see if Guselkumab can help achieve clinical remission, which means reducing the symptoms of Ulcerative Colitis to a minimal level. The trial will also look at the safety of the medication and how it is processed in the body. This research is important for understanding if Guselkumab can be a beneficial treatment option for young people with this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Induction phase
The trial begins with the induction phase, where the medication guselkumab is administered. This phase is designed to evaluate the initial response to the treatment.
During this phase, guselkumab is given as a solution for injection using a pre-filled syringe. The administration is done subcutaneously (under the skin).
Step 2
Maintenance phase
Following the induction phase, participants who respond to the treatment enter the maintenance phase. This phase is conducted in a double-blind manner, meaning neither the participant nor the researchers know who is receiving the active medication or a placebo.
The goal of this phase is to maintain the response achieved during the induction phase. The medication continues to be administered subcutaneously.
Step 3
Evaluation of efficacy and safety
Throughout the trial, the efficacy and safety of guselkumab are closely monitored. This includes regular assessments to determine the impact of the medication on ulcerative colitis symptoms.
The primary endpoint is to achieve clinical remission by Week 56, as measured by a modified Mayo score, which evaluates the severity of the condition.
Step 4
End of trial
The trial is expected to conclude by August 2028. At the end of the trial, the overall results will be analyzed to determine the long-term effectiveness and safety of guselkumab in treating pediatric participants with moderately to severely active ulcerative colitis.

Who can join the trial?

7 criteria

Participants must be between 2 and 17 years old at the time they first receive the study treatment.
Participants must weigh at least 10 kilograms when they agree to join the study.
A report confirming a diagnosis of **Ulcerative Colitis (UC)** must be available. If not, a test called an endoscopy, done within 3 weeks before starting the study treatment, must confirm the diagnosis.
Participants must have **moderately to severely active UC**. This is determined by a specific score from tests and evaluations, including a video review of an endoscopy.
Participants must have either:
- Previously tried and not responded well to certain advanced treatments for UC, or could not tolerate them. These treatments include TNFα antagonists, vedolizumab, ozanimod, or JAK inhibitors.
- Not used advanced treatments before but have a history of not responding well to or not tolerating other UC medications like oral or IV corticosteroids, aminosalicylates, or immunomodulators.
- A history of needing corticosteroids regularly, known as **corticosteroid dependence**.

Who cannot join the trial?

10 criteria

Patients who have a different condition than Ulcerative Colitis cannot participate. Ulcerative Colitis is a condition that causes inflammation and sores in the colon and rectum.
Patients who are not within the specified age range for the study cannot participate. The study is for pediatric participants, which means it is for children.
Patients who have not responded to the initial treatment phase, known as induction therapy, cannot participate. Induction therapy is the first step in treatment to see if the medication works for the patient.
Patients who are not considered to have moderately to severely active Ulcerative Colitis cannot participate. This means the condition must be at a certain level of activity or severity.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other health conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have a history of certain infections or diseases that could affect the study cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to join this study.

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Verified sites

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Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

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Investigated drugs

Guselkumab is a medication being studied for its effectiveness in treating children with moderately to severely active ulcerative colitis. It works by targeting specific proteins in the immune system to help reduce inflammation in the colon. This trial aims to see how well it works and how safe it is for children who respond to initial treatment.

Guselkumab

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating ulcerative colitis, particularly in pediatric patients with moderate to severe cases. The medication works by targeting a specific protein in the immune system called interleukin-23, which plays a role in inflammation. By blocking this protein, guselkumab helps reduce inflammation in the colon. It is classified as a monoclonal antibody, a type of medication designed to target specific components of the immune system.

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 flare-ups and remissions. 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.