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Study on Belimumab for Children with Systemic Lupus Erythematosus (SLE)

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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 a disease called Systemic Lupus Erythematosus (SLE), which is a condition where the immune system mistakenly attacks healthy tissues in the body. The trial is testing a treatment called Belimumab, which is a type of medication known as a monoclonal antibody. This medication is designed to target and block a specific protein in the body that is involved in the immune response, potentially helping to reduce the symptoms of SLE. The study will also use a placebo for comparison purposes.

The purpose of the study is to evaluate how effective and safe Belimumab is for children with Systemic Lupus Erythematosus. Participants in the study will receive either the medication or a placebo, along with their usual treatment for SLE. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to understand how the medication affects the body, its safety, and its impact on the quality of life of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how Belimumab works in children with Systemic Lupus Erythematosus. The study will help determine if this treatment can be a beneficial addition to the standard therapy for managing SLE in pediatric patients. The results will contribute to a better understanding of the treatment options available for this condition.

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 will be required to sign a consent form. This form confirms understanding of the study requirements and agreement to comply with the procedures.

    The participant must meet specific criteria, such as being between 5 to 17 years old and having a confirmed diagnosis of systemic lupus erythematosus (SLE).

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's health status. This includes confirming active SLE disease with a SELENA SLEDAI score of 6 or higher.

    The participant must have positive autoantibody test results, which are specific blood tests that help confirm the presence of SLE.

  3. Step 3

    Treatment regimen

    The participant will receive a medication called belimumab, administered through an intravenous infusion. This means the medication is given directly into a vein.

    The dosage and frequency of belimumab will be determined by the study protocol, and it will be given alongside the participant's existing stable SLE treatment regimen.

  4. Step 4

    Ongoing monitoring

    Throughout the study, the participant's health will be closely monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment.

    The participant will be evaluated for any changes in their SLE symptoms and overall health, using various assessment tools and questionnaires.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation will be conducted. This will assess the participant's response to the treatment and any changes in their quality of life.

    The study aims to determine the efficacy of belimumab in treating pediatric SLE and its impact on the participant's health and well-being.

Who can join the trial?

7 criteria

  • Participants must be between 5 and 17 years old.
  • Participants must have or have had at least 4 of the 11 criteria set by the American College of Rheumatology for classifying **Systemic Lupus Erythematosus (SLE)**, which is a condition where the immune system attacks the body's own tissues.
  • Participants must have active SLE, shown by a **SELENA SLEDAI score** of 6 or higher. This score is a way to measure the activity of the disease.
  • Participants must have clear positive results from an **autoantibody test**. This means having an **ANA titre** of 1:80 or higher, or a positive **anti-dsDNA** test, which are tests that help confirm the presence of SLE.
  • Participants must be on a stable treatment plan for SLE. This means their medication doses have not changed for at least 30 days before starting the study. Medications can include corticosteroids, immunosuppressive drugs, anti-malarials, and NSAIDs.
  • If a participant is a sexually active female, she must not be pregnant or nursing. She must either be unable to have children or agree to use effective birth control methods during the study.
  • The participant must sign a form showing they agree to take part in the study, and their parent or guardian must also give written consent. This means they understand what the study involves and agree to follow the study's rules and attend required visits.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other experimental drug within the last 30 days.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Belimumab is a human monoclonal antibody used in this trial to treat pediatric patients with systemic lupus erythematosus (SLE). It works by targeting and inhibiting a specific protein in the body called BLyS, which is involved in the production of antibodies. By reducing the activity of BLyS, belimumab helps to decrease the abnormal immune response seen in lupus, potentially improving symptoms and quality of life for patients.

What is already known about the treatment

Belimumab – Belimumab is administered as an intravenous infusion or subcutaneous injection. It is currently being studied in clinical trials for its effectiveness in treating pediatric patients with Systemic Lupus Erythematosus (SLE). The main therapeutic indication for belimumab is to reduce disease activity in patients with SLE. At the molecular level, belimumab works by targeting and inhibiting the activity of a protein called B-lymphocyte stimulator (BLyS), which plays a role in the survival of B cells that contribute to the autoimmune response in lupus. It is classified pharmacologically as a human monoclonal antibody.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever. The disease can progress with periods of flares, where symptoms worsen, and remissions, where symptoms improve. The severity and progression of SLE can vary widely among individuals. It is more common in women and can develop at any age, though it often starts in young adulthood.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-512730-15-00Protocol code114055Estimated enrolment77 patientsSponsorGlaxosmithkline Research & Development Limited

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