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RECRUITING
NCT03543839
PHASE4

Trial of Belimumab in Early Lupus

Sponsor: Northwell Health

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.

Official title: Pilot Trial of Belimumab in Early Lupus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2020-09-15

Completion Date

2026-12

Last Updated

2024-02-14

Healthy Volunteers

No

Interventions

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

Locations (1)

Feinstein Institute

Manhasset, New York, United States