RecruitingPhase 4NCT03543839

Trial of Belimumab in Early Lupus

Pilot Trial of Belimumab in Early Lupus


Sponsor

Northwell Health

Enrollment

30 participants

Start Date

Sep 15, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Belimumab, a biological treatment called Belimumab/Placebo, and others for people with lupus erythematosus and lupus erythematosus, systemic. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBelimumab

Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years

BIOLOGICALBelimumab/Placebo

Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.

OTHERPlacebo

Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years


Locations(1)

Feinstein Institute

Manhasset, New York, United States

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NCT03543839


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