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

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What is this study about?

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 study involves a treatment called belimumab, which is a type of medication known as a monoclonal antibody. This medication is designed to help manage the symptoms of SLE by targeting specific proteins in the immune system that contribute to the disease.

The purpose of this study is to understand how belimumab works in children with SLE when it is given as an injection under the skin. Participants in the study will receive the medication in a pre-filled pen, which is a device that makes it easier to administer the injection. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. 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.

Throughout the study, researchers will collect information on how the body processes belimumab and how safe it is for use in children with SLE. They will also look at how the treatment affects certain markers in the blood that are related to the disease. This information will help doctors understand more about the potential benefits and risks of using belimumab in young patients with SLE, and could lead to improved treatment options in the future.

1 Joining the study

Upon joining the study, the participant must meet specific criteria, including age between 5 and 17 years, a diagnosis of systemic lupus erythematosus (SLE), and a stable treatment regimen for at least 30 days prior to the start of the study.

The participant must weigh at least 15 kg and, if female, must not be pregnant or breastfeeding. Written consent is required from the participant and their guardian.

2 Initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline health metrics. This includes a review of medical history, current medications, and a physical examination.

3 Medication administration

The participant receives belimumab, a medication administered subcutaneously. The dosage is 200 mg, provided in a pre-filled pen for injection.

The medication is administered according to the study schedule, which is designed to evaluate its effects in combination with the participant’s standard therapy.

4 Regular monitoring

Throughout the study, the participant undergoes regular monitoring to assess the medication’s effects. This includes measuring belimumab concentrations at Week 12 and evaluating steady-state pharmacokinetic parameters.

The participant is also monitored for any adverse events or changes in health status.

5 Follow-up assessments

Follow-up assessments are conducted at Weeks 12 and 52 to evaluate changes in specific biomarkers and overall health.

These assessments help determine the medication’s impact on the participant’s condition and any potential side effects.

6 Completion of the study

The study is expected to conclude by April 2025. Upon completion, the participant’s health and response to the medication are thoroughly evaluated.

The results contribute to understanding the medication’s safety and effectiveness in treating pediatric SLE.

Who Can Join the Study?

The participant must be between 5 and 17 years old at the start of the study.
The participant must meet the 1997 American College of Rheumatology criteria for Systemic Lupus Erythematosus (SLE), which means having or having had at least 4 out of 11 specific criteria for SLE.
The participant must have active SLE, shown by a SELENA SLEDAI score of 6 or higher during screening. This score is a way to measure how active the disease is.
The participant must have a positive autoantibody test during the screening period. This means having an ANA titre of 1:80 or higher, or a positive anti-dsDNA test, which are specific blood tests used to help diagnose SLE.
The participant must be on a stable SLE treatment plan for at least 30 days before the study starts. This can include medications like corticosteroids, immunosuppressive drugs, anti-malarials, or NSAIDs. No new SLE treatments should be started within 30 days of the study.
The participant must weigh at least 15 kg (about 33 pounds).
Both male and female participants can join. Female participants must not be pregnant or breastfeeding. If they can have children, they must use a highly effective birth control method during the study and for 16 weeks after the last dose of the study drug. They must also have a negative pregnancy test before starting the study.
The participant and their parent or legal guardian must sign a consent form, showing they understand the study requirements and agree to follow the study procedures.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	06.02.2020
Spain	Not recruiting	06.02.2020

Trial locations

Investigated drugs:

Belimumab

Belimumab is a human monoclonal antibody used in this trial. It is designed to target and inhibit a specific protein called BLyS, which is involved in the survival of certain immune cells. By blocking BLyS, belimumab helps reduce the activity of the immune system, which can be beneficial for patients with systemic lupus erythematosus (SLE), an autoimmune disease where the immune system attacks the body’s own tissues. In this trial, belimumab is administered subcutaneously, meaning it is injected under the skin, to evaluate its effects on children with SLE.

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 vary greatly in severity and may have periods of flares and remissions. Over time, SLE can lead to inflammation and damage in the affected organs. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.

Trial ID:

2023-509413-37-00

Protocol code:

200908

NCT ID:

NCT04179032

Trial Phase:

Therapeutic exploratory (Phase II)

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

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