Trial of Belimumab in Early Lupus

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT03543839
Phase
PHASE4
Status
Recruiting
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Conditions

  • Lupus Erythematosus
  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2020
Status verified
Feb 2024
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Belimumab
    Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years
  • Experimental: Belimumab/Placebo
    Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 1 year and then placebo injections subcutaneously for 1 year.
  • Placebo Comparator: Placebo
    Subjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years

Primary Outcome Measure

Frequency of anergic autoreactive naïve B cells [ Time Frame: Assessment at year 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Feinstein InstituteManhassetNew York11030
Sanita Kandasami
[email protected]
516-562-2401
Cynthia Aranow, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Feinstein Institute· Manhasset, NY

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