Clinical Trial

Trial of Belimumab in Early Lupus

Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2018-05-31; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2020-10-18
Trial Details
NCT Number NCT03543839
Lead Sponsor Northwell Health
Collaborators: GlaxoSmithKline
Conditions Lupus Erythematosus, Systemic, Lupus Erythematosus
Enrollment 30 participants
Start Date 2020-09-15
Primary Completion 2028-09 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-12