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Study on the Long-term Safety of Guselkumab for Children with Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

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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 Guselkumab in children and teenagers who have certain conditions. These conditions include Juvenile Psoriatic Arthritis, which is a type of arthritis that affects children and causes joint pain and swelling, Ulcerative Colitis, a disease that causes inflammation and sores in the colon, and Crohn's Disease, which is another type of inflammatory bowel disease that can affect any part of the gastrointestinal tract.

The treatment being studied is Guselkumab, 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 aims to observe how safe this medication is when used over a long period in young patients with these conditions. Participants in the study will receive the medication and be monitored by healthcare professionals to ensure their safety and to gather information about any side effects they might experience.

The study will take place over a period of time, allowing researchers to collect data on the long-term effects of Guselkumab. Participants will continue to receive the medication as part of their treatment plan, and their health will be regularly checked by the study team. This research is important to understand how well the medication works and how safe it is for children and teenagers with these specific health conditions.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after completing the dosing planned in the primary pediatric guselkumab study.

    Continued benefit from guselkumab therapy must be observed by the investigator.

  2. Step 2

    Medication administration

    The medication used in this study is guselkumab, provided as a solution for injection in a pre-filled syringe.

    The administration route is subcutaneous use, meaning the injection is given under the skin.

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

  3. Step 3

    Monitoring and safety evaluation

    The main objective is to evaluate the long-term safety of guselkumab in pediatric participants with conditions such as juvenile psoriatic arthritis, moderately to severely active ulcerative colitis, or Crohn's disease.

    No primary or secondary endpoints will be collected, focusing solely on safety.

  4. Step 4

    Study duration

    The estimated end date for the study is December 12, 2031.

    The recruitment for the study is expected to start on October 21, 2024.

Who can join the trial?

5 criteria

  • The patient must have completed the planned treatment in the initial study involving the medication called guselkumab.
  • The patient must have shown improvement from continuing guselkumab treatment, as determined by the doctor overseeing the study.
  • Before joining the study, the patient must either be unable to have children or, if able to have children, must not be sexually active, or must use a very effective form of birth control. This must continue while receiving the study treatment and for 12 weeks after the last dose.
  • The patient's parent(s) or legal guardian must sign a form indicating they understand the study's purpose and procedures and agree to let the child participate. Children who can understand the study must also agree to participate. If a child becomes an adult during the study, they will have the chance to sign an adult consent form to continue participating.
  • The patient must be willing and able to follow the lifestyle rules specified in the study plan.

Who cannot join the trial?

9 criteria

  • Patients who do not have **juvenile psoriatic arthritis (jPsA)**, **moderately to severely active ulcerative colitis (UC)**, or **moderately to severely active Crohn's disease (CD)** cannot participate. These are specific conditions that the study is focusing on.
  • Patients who are not within the age range specified by the study. The study is looking for participants in certain age groups.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • Patients who have a history of certain infections or diseases that could affect the study results.
  • Patients who have allergies or reactions to the study medication or similar medications.
  • Patients who have used certain medications recently that might interfere with the study treatment.
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Investigated drugs

Guselkumab is a medication being studied for its long-term safety in children with certain inflammatory conditions. It is used to help manage symptoms in pediatric patients who have moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. The study aims to understand how safe this medication is for children over an extended period.

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its long-term safety in treating pediatric patients with juvenile psoriatic arthritis, moderately to severely active ulcerative colitis, and Crohn's disease. The medication works by targeting a specific protein in the immune system called interleukin-23, which plays a role in inflammation. Guselkumab is classified as a monoclonal antibody, a type of biologic therapy used to modulate the immune response.

Investigated diseases

  • Juvenile Psoriatic Arthritis

    This is a type of arthritis that affects children and is associated with psoriasis, a skin condition. It causes joint pain, swelling, and stiffness, often accompanied by patches of red, scaly skin. The disease can affect any joint and may lead to joint damage over time. Symptoms can vary in severity and may come and go, with periods of flare-ups and remission. It can also affect the nails and cause changes such as pitting or separation from the nail bed.

  • Moderately to Severely Active Ulcerative Colitis

    This is a chronic inflammatory condition affecting the colon and rectum. It causes inflammation and ulcers in the lining of the large intestine, leading to symptoms like abdominal pain, diarrhea, and rectal bleeding. The disease often 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 involves an abnormal immune response in the gut.

  • Moderately to Severely Active Crohn's Disease

    This is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract, from the mouth to the anus. It causes inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, and weight loss. The disease is characterized by periods of active symptoms and remission. Over time, it can lead to complications like strictures, fistulas, or malnutrition. The exact cause is not fully understood, but it involves an abnormal immune response.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509560-16-00Protocol codeCNTO1959ISD3001Estimated enrolment178 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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