Recruiting

Belimumab

Sponsor:

Northwell Health

Code:

NCT03543839

Conditions

Lupus Erythematosus, Systemic

Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Belimumab

Belimumab/Placebo

Placebo

Study Details

Brief 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

Study ID

NCT03543839

Start date

Sep 15, 2020

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
  • History of a primary immunodeficiency
  • Have a significant IgG deficiency (IgG level < 400 mg/dL)
  • Have an IgA deficiency (IgA level < 10 mg/dL)
  • Have any other clinically significant abnormal laboratory value in the opinion of the investigator
  • Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months
  • Inability to comply with study and follow-up procedures

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Belimumab

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

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.

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sanita Kandasami, BS

516 562-2401skandasami@northwell.edu

Cynthia Aranow, MD

516 562-3845caranow@northwell.edu

Locations

Feinstein Institute

Recruiting

Manhasset, New York, United States, 11030

Contacts

Sanita Kandasami

516-562-2401skandasami@northwell.edu

Principal Investigator:

Cynthia Aranow, M.D.

More Information

Sponsor

Northwell Health

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • lupus
  • early lupus
  • belimumab
  • autoreactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-12.