Belantamab for Lupus

Recruiting at 4 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must be taking: Immunosuppressants, Steroids

Disqualifiers: Severe lupus flare, Unstable SLE, Catastrophic APS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but active autoimmune disease.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How is the drug Belantamab different from other lupus treatments?

Belantamab is unique because it is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill certain cells, a mechanism not commonly used in lupus treatments. This targeted approach may offer a novel way to manage lupus compared to traditional therapies that broadly suppress the immune system. ^{1 2 3 4 5}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for men and women aged 18 to 75 who have moderate to severe systemic lupus erythematosus (SLE), a chronic autoimmune disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

My lupus is moderate to severe.

I am using or willing to use contraception.

Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height^2), inclusive, and body weight of ≥40 kg

Exclusion Criteria

I have had a severe lupus flare-up recently that required immediate treatment.

My lupus symptoms are getting worse.

My lupus has caused permanent damage to one or more of my organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of belantamab

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Belantamab

Trial Overview The study is testing the safety of belantamab, a medication given through an IV infusion, in treating SLE. It will also monitor how the drug's levels change in the body over time and how the body responds to it.

Participant Groups

Group I: Belantamab Experimental Treatment 1 Intervention

Belantamab is already approved in United States, European Union for the following indications:

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

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

In a real-world study involving 331 patients with chronic liver disease, lusutrombopag demonstrated a high effectiveness, with 94% of patients avoiding preoperative platelet transfusions before invasive procedures.

The treatment was generally safe, with serious adverse events occurring in 8.76% of patients and only 3.32% experiencing adverse drug reactions, indicating a favorable safety profile for lusutrombopag.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance. Sasaki, R., Shiino, C., Imawari, M., et al.[2021]

In a post-marketing surveillance study involving 1033 patients with chronic liver diseases, lusutrombopag demonstrated high effectiveness, with 94.7% of patients avoiding preoperative platelet transfusions and 82.8% meeting the criteria for a significant increase in platelet count.

The safety profile of lusutrombopag was acceptable, with serious adverse reactions occurring in a small percentage of patients, and no increased risk observed in those with more severe liver disease (Child-Pugh class C) or during retreatment cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in patients who have chronic liver disease with thrombocytopenia and undergoing invasive procedures: Real-world post-marketing surveillance in Japan. Yoshiji, H., Suzuki, J., Imasaki, M., et al.[2023]

Eltrombopag, a thrombomimetic medication, has shown promising results in treating severe thrombocytopenia in a patient with systemic lupus who did not respond to conventional therapies.

The case highlights eltrombopag's potential for full recovery in lupus-associated thrombocytopenia, suggesting it may be a valuable treatment option for similar patients, although more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful platelet count recovery in lupus-associated thrombocytopenia with the thrombopoietin agonist eltrombopag. Scheinberg, P., Singulane, CC., Barbosa, LS., et al.[2021]

In a phase 3 study involving 66 patients with chronic liver disease and severe thrombocytopenia, lusutrombopag significantly increased platelet counts, with 43.2% of patients responding positively compared to only 4.5% in the placebo group.

Lusutrombopag not only reduced the need for platelet transfusions (72.7% of patients met criteria for avoiding transfusions) but also demonstrated a safety profile similar to placebo, with fewer bleeding events reported in the treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures. Ding, Z., Wu, H., Zeng, Y., et al.[2023]

In a study of 52 Hispanic patients with refractory systemic lupus erythematosus, the addition of anti-CD20 treatment (rituximab) to ongoing immunosuppressive therapy resulted in significant clinical improvements over 6 months, including a reduction in disease activity scores and remission in various symptoms.

Rituximab was particularly effective for patients with lupus nephritis, with 38.4% achieving complete renal response, and it also significantly increased platelet counts in those with autoimmune thrombocytopenia, demonstrating its potential as a valuable treatment option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-CD20 therapy in patients with refractory systemic lupus erythematosus: a longitudinal analysis of 52 Hispanic patients. Garcia-Carrasco, M., Mendoza-Pinto, C., Sandoval-Cruz, M., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in patients who have chronic liver disease with thrombocytopenia and undergoing invasive procedures: Real-world post-marketing surveillance in Japan. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Successful platelet count recovery in lupus-associated thrombocytopenia with the thrombopoietin agonist eltrombopag. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Anti-CD20 therapy in patients with refractory systemic lupus erythematosus: a longitudinal analysis of 52 Hispanic patients. [2022]