Trial of Belimumab in Early Lupus

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic, Lupus Erythematosus

In brief

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 facts

Study ID

NCT03543839

Run by

Northwell Health

People needed

30

Starts

2020-09-15

Expected to finish

2029-03-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE per current ACR classification criteria
• Date of SLE diagnosis within 2 years of screening
• ANA positive (with a titer ≥ 80)
• anti-ds DNA antibody positive
• Mild to moderate disease activity define by a SLEDAI-2K ≥4
• Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day.
• If on methotrexate, dose must be stable for 4 weeks
• Concomitant treatment with hydroxychloroquine unless documented inability to tolerate
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Negative serum pregnancy test (for women of child bearing potential)
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment

You may not qualify if…

• Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.
• Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.
• Active renal or nervous system disease or disease activity fulfilling BILAG A criteria
• Use of high dose steroids (>0.5 mg/kg/ day) within the 4 weeks prior to screening
• Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study
• Hemoglobin: < 8.0 gm/dL
• Platelets: < 50,000/mm
• ANC < 1.0 x 103/mm
• AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
• Creatinine clearance ≤ 25ml/min per 1.73 m2
• Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)
• History of positive HIV (HIV conducted during screening if applicable)
• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab
• Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
• Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
• Hospitalization for treatment of infection within 60 days of Day 0.
• Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
• History of serious recurrent or chronic infection
• Lack of peripheral venous access
• History of drug, alcohol, or chemical abuse within 365 days prior to Day 0
• Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative < 7 days prior to first dose and monthly)
• Lactation
• History of psychiatric disorder that would interfere with normal participation in this protocol
• Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Where it is running

• Feinstein Institute — Manhasset, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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