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Study on the Effectiveness and Safety of Guselkumab for Children with Moderate to Severe Crohn's Disease

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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 Crohn's Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The trial is specifically looking at children with moderately to severely active Crohn's Disease. The treatment being tested is called Guselkumab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to substances in the body, including cancer cells, and are used to treat various diseases. In this study, Guselkumab is given as an injection under the skin or as an infusion into a vein.

The purpose of the study is to evaluate how effective and safe Guselkumab is for children with Crohn's Disease. Participants in the study will receive either Guselkumab or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see if the participants achieve clinical remission, meaning their symptoms improve significantly, and to check for any changes in the inflammation of the digestive tract.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how well the treatment works. The study aims to provide valuable insights into the potential benefits of Guselkumab for treating Crohn's Disease in children, which could lead to better treatment options in the future.

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

    Initial treatment phase

    The trial begins with the administration of guselkumab, a medication used to treat Crohn's Disease. This medication is given as a solution for injection using a pre-filled syringe.

    The injection is administered subcutaneously, which means it is injected under the skin. The dosage is 100 mg/mL.

  2. Step 2

    Maintenance therapy

    Participants who respond to the initial treatment continue with maintenance therapy using guselkumab.

    The goal of this phase is to maintain the clinical response achieved during the initial treatment phase.

  3. Step 3

    Evaluation of efficacy and safety

    The main objective of the trial is to evaluate the efficacy and safety of guselkumab in pediatric participants with Crohn's Disease.

    This evaluation occurs at the end of the maintenance therapy phase, specifically at Week 52.

  4. Step 4

    Clinical remission assessment

    At Week 52, the trial assesses whether participants have achieved clinical remission, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score of 10 or less.

    An endoscopic response is also evaluated, which involves a 50% reduction from the baseline Simple Endoscopic Score for Crohn's Disease (SES-CD).

Who can join the trial?

6 criteria

  • Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, which means they have inflammation in the digestive tract. This must be confirmed by medical tests in the past.
  • Participants must have moderately to severely active CD, which is determined by a specific score called the Pediatric Crohn's Disease Activity Index (PCDAI) that is greater than 30.
  • Participants must have had an endoscopy, a procedure where a doctor looks inside the digestive tract, showing active CD. This is measured by a score called the Simple Endoscopic Score for Crohn's Disease (SES-CD) that is 6 or higher, or 4 or higher if the disease is only in the ileum, a part of the small intestine.
  • Participants must have tried other CD medications before, such as immunomodulators, corticosteroids, or biologic therapy/JAK inhibitors, and have not responded well, lost response, or could not tolerate these treatments.
  • Participants can be of any gender.
  • Participants must be part of a vulnerable population, which means they may need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients who have a different condition than Moderately to Severely Active Crohn's Disease cannot participate.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who have not shown a positive response to the treatment by Week 12 cannot participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other health conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study cannot participate.
  • Patients who have a history of certain medical conditions that could affect the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
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Investigated drugs

Guselkumab is a medication being studied for its effectiveness and safety in treating pediatric Crohn's Disease. It works by inhibiting a specific part of the immune system known as the IL-23 pathway, which is thought to play a role in the inflammation associated with Crohn's Disease. The trial aims to see how well this medication helps children who have shown improvement after 12 weeks of treatment.

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active Crohn's Disease, particularly in pediatric patients. It is a monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammatory processes. By inhibiting IL-23, guselkumab helps reduce inflammation and immune response, which are key factors in Crohn's Disease. It is classified as an immunosuppressive agent and is being evaluated for its safety and efficacy in maintaining clinical response in patients.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can vary in severity, with some individuals experiencing mild symptoms and others having more severe manifestations. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504735-41-00Protocol codeCNTO1959PBCRD3007Estimated enrolment88 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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