Belimumab for Lupus

Recruiting at 15 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must be taking: Corticosteroids, Immunosuppressives, Anti-malarials, NSAIDs

Must not be taking: B-cell therapies, Anti-TNF, IVIG, others

Disqualifiers: Severe nephritis, Organ transplant, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called belimumab, given as an injection under the skin, in children with lupus. The goal is to see if it is safe and effective by calming down their overactive immune systems. Belimumab is approved for the treatment of lupus in adults with moderate disease activity.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, participants must be on a stable SLE treatment regimen for at least 30 days before starting the trial, which includes medications like corticosteroids, immunosuppressive agents, anti-malarials, and NSAIDs.

What data supports the effectiveness of the drug Belimumab for treating lupus?

Belimumab (Benlysta) has been shown in clinical trials to effectively reduce disease activity and flares in patients with active systemic lupus erythematosus (SLE) who have not responded well to standard treatments. It also helps lower the need for other medications and improves quality of life for these patients. ^{1 2 3 4 5}

Is belimumab safe for humans?

Belimumab, also known as Benlysta, has been studied for its safety in treating systemic lupus erythematosus (SLE). Research shows that it has a safety profile that supports its use in combination with standard therapy for SLE, and it has been approved by health authorities like the US FDA and the European Medicines Agency for this purpose. ^{2 4 6 7 8}

What makes the drug Belimumab unique for treating lupus?

Belimumab (Benlysta) is unique because it is the first drug approved in 50 years specifically for systemic lupus erythematosus (SLE) and works by targeting and inhibiting a protein that helps B cells survive and multiply, which are involved in the disease. It can be administered either intravenously or subcutaneously, offering flexibility in treatment. ^{1 2 3 4 5}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for children aged 5 to 17 with Systemic Lupus Erythematosus (SLE) who weigh at least 15 kg. They should have active SLE, positive autoantibody test results, and be on a stable treatment regimen for at least 30 days prior to the start of the study. Participants must not be pregnant or breastfeeding and agree to use effective contraception.

Inclusion Criteria

No contraceptive measures are required for male participants.

I meet at least 4 of the criteria for lupus.

I am either male or female.

Exclusion Criteria

I have severe kidney inflammation that might need treatment in the first 12 weeks of the trial.

I am on medication for a long-term infection like TB or herpes.

I've needed 3 or more steroid treatments for another condition in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of Belimumab based on body weight for 12 weeks

12 weeks

Weekly or bi-weekly visits depending on body weight

Open-label continuation

Optional continuation of treatment with Belimumab for participants who completed the initial treatment phase

40 weeks

Visits as per dosing schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Belimumab

Trial Overview The trial tests subcutaneous injections of Belimumab in pediatric patients with SLE. It aims to understand how the drug behaves in their bodies (pharmacokinetics), its safety profile, and how it affects disease activity (pharmacodynamics). The study includes an initial 12-week treatment phase followed by an optional 40-week continuation.

Participant Groups

Group I: Belimumab 200 mg Experimental Treatment 1 Intervention

Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

Belimumab is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in European Union as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Canada as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Japan as Benlysta for:

• Systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Belimumab is a monoclonal antibody that effectively targets and inhibits B-cell activating factor, leading to reduced B-cell levels and improved disease activity in patients with active systemic lupus erythematosus (SLE).

Clinical trials and post-marketing data indicate that belimumab is beneficial for lupus patients who continue to experience active disease despite receiving standard of care therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing experiences with belimumab in the treatment of SLE patients. Askanase, AD., Yazdany, J., Molta, CT.[2015]

In a study of 17 female patients with lupus nephritis treated with belimumab for a median of 36 months, all patients experienced resolution of arthralgia and skin manifestations, indicating its efficacy in managing these symptoms.

Belimumab treatment led to normalization of proteinuria in three patients and allowed for the reduction or complete withdrawal of corticosteroids in 35% of patients, demonstrating its potential to improve kidney function and reduce reliance on steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab may decrease flare rate and allow glucocorticoid withdrawal in lupus nephritis (including dialysis and transplanted patient). Binda, V., Trezzi, B., Del Papa, N., et al.[2021]

Belimumab (Benlysta®) is an effective treatment for adults with active, autoantibody-positive systemic lupus erythematosus (SLE), particularly for those who have high disease activity despite standard therapy.

In multinational trials, patients receiving belimumab showed significantly higher rates of achieving an SLE Responder Index response at 52 weeks compared to those receiving a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab: a guide to its use in systemic lupus erythematosus. Scott, LJ., Burness, CB., McCormack, PL.[2016]

Benlysta (belimumab) is the first new drug approved for systemic lupus erythematosus (SLE) in 50 years, providing a new treatment option for patients with this complex disease.

Clinical trials suggest that Benlysta is effective in reducing SLE activity and flares in patients who are antinuclear antibody-positive, potentially allowing for lower doses of background medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab and the clinical data. Shum, K., Askanase, A.[2021]

Belimumab is an effective add-on therapy for adults with active, autoantibody-positive systemic lupus erythematosus (SLE), showing significant reductions in disease activity and flare severity in phase III trials.

The treatment is generally well tolerated, has low rates of immunogenicity, and offers benefits such as steroid-sparing effects and improved quality of life, making it a convenient option for long-term management of SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab: A Review in Systemic Lupus Erythematosus. Blair, HA., Duggan, ST.[2019]

In a study involving 364 patients with systemic lupus erythematosus (SLE), long-term treatment with belimumab combined with standard therapy demonstrated a stable or declining incidence of adverse events over 4 years, indicating a favorable safety profile.

The most common side effects were mild, such as arthralgia and upper respiratory infections, and serious infusion reactions were rare, suggesting that belimumab can be safely administered for extended periods in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Merrill, JT., Ginzler, EM., Wallace, DJ., et al.[2013]

In a study of 38 Portuguese patients with Systemic Lupus Erythematosus (SLE), belimumab demonstrated significant effectiveness, with SLE Responder Index (SRI) response rates increasing from 51.9% at 6 months to 91.7% at 24 months, indicating a reduction in disease activity.

Belimumab was associated with a good safety profile, with only five patients experiencing adverse events, primarily infections, and the treatment led to a significant decrease in disease activity markers and daily steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. Fernandes, BM., Barreira, S., Fonseca, JE., et al.[2021]

Belimumab is an effective treatment for autoantibody-positive systemic lupus erythematosus (SLE) in adults, as demonstrated in phase III trials and real-world studies, showing its ability to inhibit B-lymphocyte stimulator.

The safety profile of belimumab is favorable, and there is ongoing research into its use for childhood-onset SLE and other specific SLE disease states, indicating its potential for broader applications in lupus treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab in systemic lupus erythematosus: a perspective review. Hui-Yuen, JS., Li, XQ., Askanase, AD.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Post-marketing experiences with belimumab in the treatment of SLE patients. [2015]

2. Italy pubmed.ncbi.nlm.nih.gov

Belimumab may decrease flare rate and allow glucocorticoid withdrawal in lupus nephritis (including dialysis and transplanted patient). [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Belimumab: a guide to its use in systemic lupus erythematosus. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Belimumab and the clinical data. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Belimumab: A Review in Systemic Lupus Erythematosus. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]

7. Portugal pubmed.ncbi.nlm.nih.gov

Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Belimumab in systemic lupus erythematosus: a perspective review. [2020]