GSK4527363 for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for lupus called GSK4527363 (also known as Belimumab). It aims to assess the safety, tolerability, and bodily response to this treatment. The trial consists of three parts: healthy individuals, individuals with active lupus, and healthy participants of Chinese and Japanese descent. Suitable candidates include those with a confirmed lupus diagnosis or healthy individuals of Chinese or Japanese descent. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive it.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants with active infections or those on suppressive therapy for chronic infections may not be eligible, so it's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that belimumab is generally safe for patients. Studies have found that it does not cause serious harm to the body. People with lupus who have used belimumab have experienced consistent safety, even in long-term studies, suggesting it is safe for many patients.
In contrast, GSK4527363 remains in the early stages of testing, so information about its safety in humans is limited. Early studies are needed to assess tolerance and identify any possible side effects. As it is in early trials, researchers are still gathering safety data. However, this trial marks an important first step in understanding the safety of GSK4527363 for people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GSK4527363 for lupus because it potentially offers a novel approach to treating the disease. Unlike current treatments like corticosteroids and immunosuppressants, which broadly dampen the immune system, GSK4527363 specifically targets and modulates the pathways involved in lupus. This targeted approach could lead to fewer side effects and more effective disease management. Additionally, GSK4527363 may work alongside existing treatments like belimumab, potentially enhancing therapeutic outcomes for patients with lupus.
What evidence suggests that this trial's treatments could be effective for lupus?
Research has shown that belimumab, one of the treatments in this trial, effectively treats systemic lupus erythematosus (SLE). Patients taking belimumab experience better health outcomes compared to those on a placebo. It reduces disease activity, even for those using various steroid doses.
GSK4527363, another treatment option in this trial, is a newer therapy with limited data from human studies. It aims to adjust the immune system, crucial for treating diseases like SLE. Early research examines its mechanism in the body and potential effects on the immune system.678910Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for healthy individuals and those with active Systemic Lupus Erythematosus (SLE). Participants must have a BMI of 18-32 kg/m^2, weigh at least 45 kg, and not be able to bear children. Part C specifically requires participants of Chinese or Japanese descent who haven't lived outside their country for more than 10 years.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GSK4527363 or placebo to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belimumab
- GSK4527363
Trial Overview
The study tests GSK4527363's safety and effects in different groups: healthy people, SLE patients, and healthy individuals of Chinese/Japanese ancestry. It compares the new drug against Belimumab and a placebo to see how it's tolerated and how it affects the body.
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
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
Citations
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).
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 ...
COMPARATIVE ANALYSIS OF BELIMUMAB, ...
This study aimed to evaluate the clinical and analytical outcomes in SLE patients treated with Belimumab, Anifrolumab, and Rituximab over a 1-year period.
Real-world effectiveness of intravenous belimumab in adults ...
Patients with SLE receiving IV belimumab for 6 months in real-world settings in the Russian Federation experienced overall clinical improvements and reductions ...
Efficacy of belimumab in patients with systemic lupus ...
A greater response with belimumab was seen in patients with a baseline SELENA-SLEDAI score ≥10 versus ≤9 and patients with low C3/C4 levels and ...
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- ...
Safety of belimumab in adult patients with systemic lupus ...
This post hoc pooled analysis of clinical studies evaluated the safety profile of belimumab versus placebo in adults with SLE.
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 ...
Disease Control and Safety of Belimumab Plus Standard ...
To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated ...
Impact of Belimumab on Organ Damage in Systemic Lupus ...
Accumulated data from a range of studies demonstrate that belimumab reduces key drivers of organ damage including disease activity, severe ...
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