NCT03543839

Trial of Belimumab in Early Lupus

Pilot Trial of Belimumab in Early Lupus

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.

Detailed description

This protocol proposes that early treatment of Systemic Lupus Erythematous (SLE) may prevent tissue damage and may even lead to long-term remission of disease. This concept is supported by reports of SLE-associated autoimmunity that are detected serologically many years prior to any constitutional symptoms or specific tissue inflammation and immune dysregulation precedes the development of clinically apparent SLE. Belimumab (Benlysta) is an FDA approved medication and is a monoclonal antibody directed against B cell-activating factor (BAFF)/ B Lymphocyte Stimulator (BLyS). B cells maturing in environments with high BAFF levels are more likely to be autoreactive B cells. This is a double-blind placebo controlled trial of belimumab, in patients with early lupus, ie lupus diagnosed within 2 years. Thirty subjects will be randomized (2:1) to receive subcutaneous belimumab weekly or placebo. After a year of treatment, subjects receiving belimumab will be rerandomized (1:1) to receive belimumab or placebo. The primary outcome is B cell autoreactivity. Clinical efficacy including disease activity, flares, attainment of low disease activity or remission as well as surrogate cardiovascular biomarkers will also be assessed.

Conditions

• Lupus Erythematosus, Systemic
• Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab	Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years
BIOLOGICAL	Belimumab/Placebo	Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.
OTHER	Placebo	Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years

Timeline

• Start date: 2020-09-15
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2018-06-01
• Last updated: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study