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Trial of Belimumab in Early Lupus

NCT03543839 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-14

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic
  • Lupus Erythematosus

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

Sponsors & Collaborators

Principal Investigators

  • Cynthia Aranow, MD · Feinstein Institute for Medical Research, Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543839 on ClinicalTrials.gov