Belimumab for Lupus
(BE-EARLY Trial)
Recruiting in Palo Alto (17 mi)
+114 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: GlaxoSmithKline
Must not be taking: Belimumab, Anifrolumab, Rituximab, others
Disqualifiers: Malignancy, Uncontrolled diseases, Infections, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
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.
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).
12345Is 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.
24678What 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.
12345Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Belimumab (GSK1550188)Experimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteTucson, AZ
GSK Investigational SiteApple Valley, CA
GSK Investigational SiteBeverly Hills, CA
GSK Investigational SiteFontana, CA
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKlineLead Sponsor
References
Post-marketing experiences with belimumab in the treatment of SLE patients. [2015]Belimumab (Benlysta) is a human recombinant monoclonal antibody that targets and inhibits soluble B-lymphocyte stimulator, also known as B-cell activating factor, a proliferation and survival factor for B cells. The published clinical trials data showed that in patients with active systemic lupus erythematosus (SLE), belimumab effectively reduced peripheral B-cell levels and improved disease activity. This article reviews the belimumab clinical trials and the post-marketing experience with belimumab in the treatment of those lupus patients with persistent active disease despite current standard of care (SOC) therapy.
Belimumab may decrease flare rate and allow glucocorticoid withdrawal in lupus nephritis (including dialysis and transplanted patient). [2021]Belimumab (Benlysta) is currently approved for the treatment of active Lupus despite standard therapy. Few data are available on the efficacy of this drug in lupus nephritis (LN).
Belimumab: a guide to its use in systemic lupus erythematosus. [2016]Belimumab (Benlysta®), a fully human recombinant IgG1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells, is indicated for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite receiving standard therapy. In multinational trials, significantly more belimumab recipients than placebo recipients achieved an SLE Responder Index response at 52 weeks.
Belimumab and the clinical data. [2021]Benlysta (belimumab) is a fully human recombinant monoclonal IgG antibody that neutralizes soluble B-lymphocyte stimulator and inhibits its biologic activity. Benlysta was recently approved by the US Food and Drug Administration to treat systemic lupus erythematosus (SLE). The current review discusses the data from the belimumab clinical trials and the role of this new medication in the treatment of SLE. We propose that Benlysta should be used in antinuclear antibody-positive patients with active disease in whom the goal of therapy is to decrease SLE activity, reduce flares, and help lower background medications. With this being the first drug approved for treatment of SLE in 50 years, patients have more treatment options, while researchers have a greater understanding of SLE and clinical trial design in such a heterogeneous disease.
Belimumab: A Review in Systemic Lupus Erythematosus. [2019]Belimumab (Benlysta®) is a human immunoglobulin G1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells. It is the only biological agent currently approved for the treatment of non-renal systemic lupus erythematosus (SLE). Belimumab is approved in the EU, the USA and other countries as add-on therapy in adult patients with active, autoantibody-positive SLE despite standard therapy. In phase III trials, treatment with IV or SC belimumab plus standard therapy was effective in terms of reducing overall disease activity and reducing the incidence and severity of flares, without worsening of patients' overall condition or the development of significant disease activity in new organ systems. Sustained disease control was maintained during longer-term (up to 10 years) treatment with IV belimumab. Belimumab also demonstrated steroid-sparing effects and was associated with clinically meaningful improvements in health-related quality of life and fatigue. Belimumab was generally well tolerated in clinical trials, with low rates of immunogenicity. In view of the flexibility regarding the route of administration and the convenience of the once-weekly, self-administered, SC regimen, add-on therapy with belimumab is a useful treatment option for patients with active, autoantibody-positive SLE despite standard therapy.
Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]To evaluate the safety profile of long-term belimumab therapy combined with standard therapy for systemic lupus erythematosus (SLE) in patients with active disease.
Belimumab in systemic lupus erythematosus: a perspective review. [2020]Belimumab (Benlysta(®)) is a fully humanized monoclonal antibody that inhibits B-lymphocyte stimulator (also known as B cell activating factor of the tumor necrosis factor family) and was approved by the US Food and Drug Administration and the European Medicines Evaluation Agency for treatment of autoantibody-positive systemic lupus erythematosus (SLE) in adults. This review discusses the key findings of the phase III trials, post hoc analyses, and real-world postmarketing use of belimumab in the routine care of SLE patients. It also highlights the safety profile of belimumab and gives insight into its potential use to treat childhood-onset SLE. It concludes with a discussion of the current clinical trials investigating belimumab in specific SLE disease states and a look to the future with novel targeted B-cell therapies.
Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. [2021]To evaluate belimumab effectiveness and safety in real-life Portuguese patients with Systemic Lupus Erythematosus (SLE).