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Study on Ustekinumab 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 ustekinumab in children 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 study aims to understand how well ustekinumab works in helping children achieve remission, which means reducing or eliminating the symptoms of the disease.

Participants in the study will receive ustekinumab in two different forms. Initially, it will be given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. This is followed by regular doses given as a subcutaneous injection, which is an injection under the skin. The study will also include a comparison with a placebo, which is a substance with no active medication, to help understand the true effects of ustekinumab.

The study will take place over a period of time, during which participants will receive the medication and be monitored for any changes in their condition. The goal is to evaluate the safety and effectiveness of ustekinumab in managing ulcerative colitis in children, as well as to study how the body processes the medication. This research is important for developing better treatments for children 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
Initial treatment
Upon joining the study, the first step involves receiving an initial treatment with the medication ustekinumab. This is administered through an intravenous infusion, which means the medication is given directly into a vein. The specific product used is STELARA 130 mg concentrate for solution for infusion.
Step 2
Maintenance treatment
Following the initial treatment, the next phase is the maintenance treatment. This involves receiving ustekinumab through a subcutaneous injection, which means the medication is injected under the skin. The products used are either STELARA 90 mg solution for injection in pre-filled syringe or STELARA 45 mg solution for injection.
The frequency and dosage of these injections will be determined by the study protocol and communicated by the healthcare team.
Step 3
Monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate the effectiveness and safety of the treatment. This includes physical examinations, medical history reviews, and vital sign checks.
Participants will also undergo endoscopic evaluations to assess the condition of the colon, ensuring the treatment is working as intended.
Step 4
Completion of study
The study is expected to continue until June 2025. Upon completion, participants will undergo final assessments to determine the overall impact of the treatment on their condition.
The primary goal is to achieve clinical remission by Week 8, which means the symptoms of ulcerative colitis are significantly reduced or absent.

Who can join the trial?

5 criteria

The patient must be medically stable based on a physical exam, medical history, and vital signs. Any unusual findings should be related to the condition being studied and noted by the doctor.
The patient must have been diagnosed with Ulcerative Colitis (UC) before the screening.
The patient must have moderately to severely active UC, which means having a specific score (Mayo score) between 6 and 12, and a certain result from an endoscopy test.
If the patient has had extensive colitis for 8 years or more, or disease limited to the left side of the colon for 10 years or more, they must have had a full colonoscopy within the last year to check for abnormal cell growth (dysplasia) or have one during the screening period. The results must show no dysplasia before starting the study treatment.
Females who can have children must have a negative pregnancy test at the screening and before starting the study treatment.

Who cannot join the trial?

10 criteria

Patients with any other significant health condition 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 any other investigational drug within a certain period before the study.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of certain types of cancer.
Patients who have a history of certain blood disorders.
Patients who have a history of certain liver or kidney diseases.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures or follow-up visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Cliniques Universitaires Saint-Luc
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Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
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Leuven, Belgium
Semmelweis University
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Budapest, Hungary

Trial locations

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Investigated drugs

Ustekinumab is a medication used in this clinical trial to help treat children with a condition called ulcerative colitis, which causes inflammation and sores in the large intestine. This medication works by targeting specific proteins in the body that are involved in the inflammation process. By doing so, it helps reduce the symptoms of ulcerative colitis, such as abdominal pain and diarrhea, and aims to bring the disease into remission, meaning the symptoms are reduced or disappear. In this study, the medication is first given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein, and then it is given as an injection under the skin to maintain its effects over time. The trial is designed to assess how well this medication works, how safe it is for children, and how the body processes it.

Ustekinumab

What is already known about the treatment

Ustekinumab – Ustekinumab is administered as an intravenous infusion initially, followed by subcutaneous injections for maintenance. It is currently being studied in clinical trials for its effectiveness and safety in treating children with moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. Ustekinumab works by targeting specific proteins in the immune system that contribute to inflammation, helping to reduce symptoms and promote remission. It is classified as a monoclonal antibody, a type of medication 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 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.