Belimumab for Lupus

(BE-EARLY Trial)

Recruiting at 135 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: GlaxoSmithKline

Must not be taking: Belimumab, Anifrolumab, Rituximab, others

Disqualifiers: Malignancy, Uncontrolled diseases, Infections, 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: 52 weeks

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does list certain medications and treatments that are not allowed before or during the study. It's best to discuss your specific medications with the study team to see if they are permitted.

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

Belimumab has been shown to effectively reduce disease activity and flares in patients with active lupus, even when standard treatments are not enough. Clinical trials have demonstrated that it helps control symptoms and improve quality of life for those with systemic lupus erythematosus (SLE). ^{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 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 Evaluation Agency. ^{2 4 6 7 8}

What makes the drug Belimumab unique for treating lupus?

Belimumab is unique because it is the first drug approved in 50 years specifically for systemic lupus erythematosus (SLE), and it works by targeting and inhibiting a protein that helps B cells survive and multiply, which are involved in the disease. It offers flexibility in administration, as it can be given intravenously or as a self-administered injection, and it helps reduce disease activity and flares in patients who do not respond to standard treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for adults with early-stage Systemic Lupus Erythematosus (SLE) who have ongoing symptoms despite treatment. Participants must meet certain criteria, including a specific SLE disease activity score or be on a stable dose of steroids. Women capable of having children must use effective contraception, and all participants should have been diagnosed within the last two years.

Inclusion Criteria

My lupus has not caused any long-term damage according to the SLICC/ACR Damage Index.

My lupus is active, or I'm on high-dose steroids for it.

I am able to understand and sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belimumab for the treatment of early systemic lupus erythematosus

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants continue to be monitored for long-term efficacy and safety of belimumab

2 years

Treatment Details

Interventions

• Belimumab

Trial Overview The study is testing the safety and effectiveness of Belimumab in treating SLE over three years. It's an open-label trial, meaning both researchers and participants know what treatment is being given, focusing on those who've recently been diagnosed and are still experiencing active symptoms.

Participant Groups

Group I: Belimumab (GSK1550188) Experimental Treatment 1 Intervention

Participants will receive GSK1550188.

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

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

8. Portugal pubmed.ncbi.nlm.nih.gov

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