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Study on Long-term Safety of Ustekinumab for Children with Crohn's Disease, Juvenile Psoriatic Arthritis, or 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 long-term safety of a medication called ustekinumab, which is used to treat certain inflammatory diseases in children and teenagers aged 2 to under 18 years. The diseases being studied include Crohn's Disease, Juvenile Psoriatic Arthritis, and Ulcerative Colitis. These conditions are characterized by inflammation in different parts of the body, such as the digestive tract and joints. The medication, known by the brand name Stelara, is given as a solution for injection under the skin.

The purpose of this study is to gather information on the long-term safety of ustekinumab in young patients who have already participated in a previous study with this medication. Participants will continue to receive the medication over a period of time, and their health will be monitored to ensure the treatment remains safe. The study will involve regular check-ups and assessments to track any side effects or changes in the participants' conditions.

Throughout the study, researchers will pay close attention to any adverse events, which are unexpected medical problems that may occur during treatment. They will also monitor for any reactions at the injection site and any changes in the participants' health that might indicate a worsening of their disease. The study aims to provide valuable information about the long-term use of ustekinumab in managing these chronic conditions in young patients.

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 must have completed the dosing planned in the primary pediatric ustekinumab study. The participant should have shown a benefit from continued ustekinumab therapy, such as a clinical response or remission, as defined in the primary study.

  2. Step 2

    Informed consent

    The parent(s), legal guardian(s), or legally acceptable representative must sign an informed consent form (ICF) indicating understanding of the study's purpose and procedures. Children capable of understanding the study, typically aged 7 and older, must also provide assent. Adolescents reaching the age of majority during the study will have the opportunity to sign an adult ICF.

  3. Step 3

    Medication administration

    The participant will receive ustekinumab, which is administered as a solution for injection. The medication is given through subcutaneous use, meaning it is injected under the skin. The specific dosage and frequency will be determined based on the participant's previous treatment in the primary study.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the participant will be monitored for any adverse events (AEs), serious adverse events (SAEs), and any reactions at the injection site. Regular clinical laboratory tests, including hematology and chemistry, will be conducted to ensure safety. The participant's condition will be assessed to check for any worsening of the disease or need for additional therapy.

  5. Step 5

    Study duration

    The study is a long-term extension, estimated to end by December 15, 2027. The participant will continue to receive treatment and monitoring as outlined in the study protocol until the study concludes or until it is determined that the participant should discontinue for any reason.

Who can join the trial?

6 criteria

  • Must be a male or female between the ages of 2 and 17 years old.
  • Must have completed the planned treatment in the initial pediatric study with ustekinumab, which is a type of medication.
  • Must have shown a benefit from continuing ustekinumab treatment, meaning there was a positive response or improvement in their condition as determined in the initial study.
  • A parent, legal guardian, or legally acceptable representative must sign a form indicating they understand the study and agree to allow the child to participate. This is called an Informed Consent Form (ICF).
  • Children who are capable of understanding the study, usually those 7 years and older, must also agree to participate. This is called giving assent.
  • If a child reaches adulthood during the study, they will have the chance to sign an adult consent form to continue participating.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • 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 with a history of severe allergic reactions to medications.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients with certain blood disorders or abnormalities.
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Investigated drugs

Ustekinumab is a medication used in this clinical trial. It is designed to help manage certain inflammatory conditions by targeting specific proteins in the immune system that can cause inflammation. This medication is often used to treat conditions like psoriasis, psoriatic arthritis, and Crohn's disease. In this trial, the focus is on understanding the long-term safety of using Ustekinumab in children and teenagers who are between 2 and 18 years old. The goal is to see how well the medication works over a longer period and to ensure it is safe for young patients to use. Participants in the trial will receive Ustekinumab to help control their symptoms and improve their quality of life while researchers monitor any side effects or issues that may arise during the study.

What is already known about the treatment

Ustekinumab – Ustekinumab is administered as an injection, typically under the skin, and is used to treat several inflammatory conditions. It is currently recognized in medical literature as a treatment for conditions like moderately to severely active Crohn's disease, juvenile psoriatic arthritis, and moderately to severely active ulcerative colitis. The medication works by targeting specific proteins in the immune system that cause inflammation, helping to reduce symptoms and manage the disease. Ustekinumab is classified as a monoclonal antibody, which is a type of drug designed to interact with the immune system.

Investigated diseases

  • Crohn's Disease

    Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract. It can affect any part of the digestive system, from the mouth to the anus, but most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease often progresses with periods of remission and flare-ups. Over time, it can cause complications like strictures, fistulas, and abscesses. The exact cause of Crohn's Disease is unknown, but it involves an abnormal immune response.

  • Juvenile Psoriatic Arthritis

    Juvenile Psoriatic Arthritis is a type of inflammatory arthritis that affects children and is associated with the skin condition psoriasis. It causes joint pain, swelling, and stiffness, often in the fingers and toes, and can also lead to changes in the nails. The disease can progress to involve larger joints and the spine. Symptoms may appear in cycles, with periods of increased activity followed by times of remission. The skin symptoms of psoriasis, such as red patches with silvery scales, may precede or follow the onset of arthritis. The exact cause is not fully understood, but it involves genetic and immune system factors.

  • Ulcerative Colitis

    Ulcerative Colitis is a chronic inflammatory condition that affects the colon and rectum. It causes inflammation and ulcers in the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The progression of Ulcerative Colitis is marked by periods of exacerbation and remission. Over time, it can lead to complications such as severe bleeding, perforation of the colon, and increased risk of colon cancer. The exact cause is unknown, but it involves an abnormal immune response in the gut.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501067-40-00Protocol codeCNTO1275ISD3001Estimated enrolment189 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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