Active not recruitingPHASE2INTERVENTIONAL

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

This study is investigating a new way to give belimumab, a medicine for Systemic Lupus Erythematosus (SLE), to children aged 5 to 17. Instead of an IV drip, it's given as an injection under the skin. The main goals are to check how the body handles the medicine, how safe it is, and its effects, while children continue their usual lupus treatments. This research helps decide if this injection can be used for children with lupus, building on what we know from adult studies and other studies in children. It's hoped that the injection will work similarly to how it does in adults, offering a potentially easier way to manage their condition.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

28 Nov 2019

Estimated completion

26 Apr 2027

Systemic Lupus Erythematosus

Results

Results from this study

Posted March 2024

Results have been published for this study.

Primary outcome

Observed Belimumab Concentrations at Week 12

Blood samples were collected for measurement of serum concentrations of belimumab. Observed belimumab concentrations at Week 12 is presented.

Full results on the registry

What is this study about?

This study is about a medicine called belimumab, which is used to treat Systemic Lupus Erythematosus, often just called lupus. Lupus is a long-term illness where the body's immune system mistakenly attacks its own tissues and organs. While belimumab is already used for lupus, this study is exploring a new way to give it to children and teenagers aged 5 to 17.

Currently, belimumab can be given as a drip into a vein (called intravenous or IV). This study is looking at giving it as a simple injection under the skin (called subcutaneous or SC). This might be more convenient for patients and their families. The main aim is to understand how the body uses and reacts to this type of injection, to make sure it's safe and works well, similar to how adults with lupus use it.

The researchers want to see if the dose and way it's given will lead to similar levels of the medicine in children's bodies as it does in adults. This helps them bridge the information from adult studies to children, potentially making this injection an option for younger lupus patients in the future. Participants will continue to take their usual lupus medicines alongside the study drug.

Key takeaways

Exploring an injection version of belimumab for children 5-17 with lupus.
Aims to check safety, how the body uses the medicine, and its effects.
Participants continue their usual lupus treatments.
Total study duration is about 68 weeks.
Could offer a more convenient way to take belimumab in the future.

Who may be eligible?

To join this study, children and teenagers must be aged between 5 and 17 years old. They need to have been diagnosed with Systemic Lupus Erythematosus (lupus) and currently have active symptoms of the disease, which will be checked by the study doctors.

They also need to be taking stable doses of their current lupus medications for at least 30 days before starting the study. This could include steroids, other immune-suppressing medicines, anti-malarials, or anti-inflammatory drugs. Participants must also weigh at least 15 kilograms (about 2 stone 5 pounds).

There are also specific blood test results related to lupus that participants need to have to be eligible. The study team will review all these details carefully with the patient and their family to ensure they meet all the requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 5 and 17 years old?
Do you have a confirmed diagnosis of lupus (SLE)?
Are you currently experiencing active lupus symptoms?
Have you been on your usual lupus medicines for at least 30 days?
Do you weigh at least 15 kilograms (around 2 stone 5 pounds)?

Answer every question to see your result.

What does participation involve?

If you join this study, it will be divided into a few parts. Firstly, there's a 12-week treatment phase where participants will receive the belimumab injection under the skin. The amount of medicine given will depend on the child's body weight. Following this, there's an optional 40-week continuation phase, where you can choose to keep receiving the medicine. During this longer phase, the dose might be adjusted if the child's weight changes.

Throughout the study, regular visits to the clinic will be needed to check on progress, conduct assessments like blood tests to monitor the medicine's levels and effects, and ensure safety. Participants will continue to take their usual lupus medicines as well. After the treatment phases, there will be a 16-week follow-up period to monitor health. The total time commitment for the study, including follow-up, will be about 68 weeks (just over a year).

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that participants might receive a new way of taking their lupus medicine that could be more convenient for them in the future. The information gathered will also help countless other children with lupus if the treatment proves safe and effective. As with any medication, there may be side effects, which the study team will monitor closely. There might also be discomfort from injections or blood tests, and the medicine might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

GSK Investigational Site
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Cincinnati, United States
GSK Investigational Site
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Rosario, Argentina
GSK Investigational Site
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Berlin, Germany
GSK Investigational Site
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Saint Augustin, Germany
GSK Investigational Site
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Kagoshima, Japan
GSK Investigational Site
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Kanagawa, Japan
GSK Investigational Site
Verified postcode
San Luis Potosí City, Mexico
GSK Investigational Site
Verified postcode
Rotterdam, Netherlands
GSK Investigational Site
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Barcelona, Spain
GSK Investigational Site
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Madrid, Spain
GSK Investigational Site
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Valencia, Spain

Common questions

What is lupus?

Lupus, or Systemic Lupus Erythematosus (SLE), is a long-term condition where your body's immune system mistakenly attacks its own tissues and organs. It can cause inflammation and damage to various body parts.

What is belimumab?

Belimumab is a medicine used to treat lupus. It works by targeting specific parts of the immune system that cause inflammation in lupus.

What's the difference between SC and IV injection?

IV (intravenous) means the medicine is given directly into a vein, usually as a drip over time. SC (subcutaneous) means the medicine is injected under the skin, which is often quicker and potentially easier to do at home or in a clinic.

Will I still take my regular lupus medicine?

Yes, all participants in this study will continue to take their usual lupus medications alongside the study drug as prescribed by their doctor.

How long will the study last?

The study will last about 68 weeks in total, which includes an initial treatment period, an optional longer treatment period, and a follow-up phase.