Belimumab for Lupus

(BE-EARLY Trial)

Recruiting at 146 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects and safety of belimumab (also known as Benlysta), a treatment for lupus, an autoimmune disease where the body attacks its own tissues. The researchers aim to assess belimumab's effectiveness both in the short term and over a longer period. The study seeks participants who have tested positive for certain antibodies, have had lupus for less than two years, and continue to experience symptoms despite ongoing treatment. Participants must also be free of major infections and certain other health conditions. As a Phase 4 trial, this research helps determine how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for belimumab?

Research shows that belimumab is generally safe for patients. Studies have found it does not cause serious side effects. Long-term research confirms belimumab remains safe for people with systemic lupus erythematosus (SLE), a type of lupus. However, it is not recommended for those with severe active lupus affecting the brain or spinal cord. In summary, belimumab is considered safe for most lupus patients, with no major safety concerns reported in the studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Belimumab is unique because it targets and blocks a specific protein called B-lymphocyte stimulator (BLyS), which plays a crucial role in the survival of B cells that can contribute to the autoimmune attack in lupus. Unlike traditional treatments for lupus, such as corticosteroids and immunosuppressants, which broadly suppress the immune system, Belimumab specifically reduces the number of abnormal B cells, potentially resulting in fewer side effects. Researchers are excited about this treatment because it offers a more targeted approach, which could lead to better management of lupus with an improved safety profile.

What is the effectiveness track record for belimumab in treating lupus?

Research has shown that belimumab effectively treats systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. Patients taking belimumab often achieve better results than those on a placebo, even when using low or high doses of prednisone, a type of steroid. Studies found that 86% of patients could reduce or stop using steroids over time with belimumab. Additionally, for those with lupus affecting the kidneys, belimumab combined with regular treatment improved kidney function. This treatment is already approved for SLE, demonstrating its effectiveness for many patients. Participants in this trial will receive belimumab to further evaluate its benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9314515/

Real-World Effectiveness of Belimumab in Systemic Lupus ... This study reports a systematic review and meta-analysis of the literature to evaluate the real-world effectiveness of belimumab for the treatment of SLE.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020763/

Outcomes of patients with systemic lupus erythematosus ... Belimumab yielded greater BICLA response frequencies than placebo irrespective of baseline glucocorticoid dose (>7.5 or ≤7.5 mg/day of a prednisone equivalent).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0011393X24000080

Usefulness of Belimumab in Adult Patients With Systemic ... The main objective of this study was to perform a meta-analysis to evaluate the efficacy of belimumab utilizing single indexes used in routine clinical ...

4. benlystahcp.com benlystahcp.com/lupus/efficacy/

Efficacy for Lupus | BENLYSTA (belimumab) for HCPs Real-world data. 86%. of patients reduced or discontinued steroids at Week 264,5. Real-world, observational cohort study, results are descriptive.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2001180

Two-Year, Randomized, Controlled Trial of Belimumab in ... In this trial involving patients with active lupus nephritis, more patients who received belimumab plus standard therapy had a primary efficacy renal response.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3389390/

Efficacy and Safety Data of Belimumab in Patients with ... Treatment with belimumab is well tolerated and has not been associated with significant toxicity. Keywords: lupus, BLyS, BAFF, belimumab, autoantibodies, B- ...

7. benlystahcp.com benlystahcp.com/safety/

Safety Profile | BENLYSTA (belimumab) for HCPs BENLYSTA is not recommended in patients with severe active central nervous system lupus. BENLYSTA is indicated for patients aged ≥5 with active systemic lupus ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01729455

NCT01729455 | Safety and Effectiveness of BENLYSTA ... Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry (SABLE). ClinicalTrials.gov ID NCT01729455.

9. lupus.bmj.com lupus.bmj.com/content/11/Suppl_2/A113.2

1501 Long-term safety of belimumab among adult patients ... Clinical trials and long-term extension (LTE) studies have demonstrated the consistent safety profile of belimumab in patients with SLE ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9679798/

Safety of belimumab in adult patients with systemic lupus ... A number of clinical trials have demonstrated the consistent safety and efficacy of belimumab in conjunction with ST in patients with SLE. Additional safety ...