Belimumab for Lupus

Not currently recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests belimumab, an immunosuppressive drug, for children aged 5 to 17 with systemic lupus erythematosus (SLE), a condition where the immune system attacks healthy tissues. The trial aims to assess how the body absorbs and reacts to the drug when administered via subcutaneous injection and to ensure its safety. Children experiencing active lupus symptoms and on stable lupus treatments may qualify for this study. Participants will receive belimumab injections based on body weight, aiming for results similar to those in adults. As a Phase 2 trial, this study measures belimumab's effectiveness in an initial, smaller group of children, contributing to important research.

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.

Is there any evidence suggesting that belimumab is likely to be safe for pediatric patients with lupus?

Research shows that belimumab is generally well tolerated by patients. Studies with adults who have systemic lupus erythematosus (SLE) indicate that this treatment usually doesn't cause serious side effects. However, belimumab is not recommended for people with severe active central nervous system lupus, which affects the brain and spinal cord.

Long-term studies have confirmed belimumab's safety, showing consistent results over time. According to current research, most patients can use belimumab without major problems. The FDA has approved belimumab for treating SLE in adults, and strong safety data supports its use.

While every treatment can have risks, several studies support belimumab's safety. Prospective trial participants can feel reassured by the existing research, but discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Belimumab is unique for treating lupus because it specifically targets and inhibits a protein called B-lymphocyte stimulator (BLyS), which plays a crucial role in the survival of antibody-producing B cells. This is different from standard treatments like corticosteroids and immunosuppressants, which broadly suppress the immune system and can come with significant side effects. Additionally, Belimumab is administered as a subcutaneous injection, offering a more convenient option compared to intravenous infusions of some other biologics. Researchers are excited because this targeted approach has the potential to reduce lupus symptoms with fewer side effects and greater patient convenience.

What evidence suggests that belimumab might be an effective treatment for lupus?

Research shows that belimumab effectively treats systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. Studies indicate that belimumab helps many patients reduce or stop using steroids, often needed to manage lupus symptoms. In everyday use, belimumab improves patients' quality of life, especially by reducing tiredness. A review of various studies supports belimumab's effectiveness in controlling lupus symptoms. Overall, belimumab serves as a helpful treatment option for managing SLE. ^{3 6 7 8 9}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

Citations

1. 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 ...

2. 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.

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869695/

Impact of Belimumab on Patient-Reported Outcomes in ... Belimumab has been shown to induce clinically important improvements in physical aspects of HRQoL and in fatigue, the latter being a common and major complaint ...

5. 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.

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

Safety of belimumab in adult patients with systemic lupus ... Additional safety data accrued from several randomized trials in specific patient populations further suggest that it is generally well tolerated. The BLISS-NEA ...

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 ...