Trial of Belimumab in Early Lupus

  • STATUS
    Recruiting
  • days left to enroll
    41
  • participants needed
    30
  • sponsor
    Northwell Health
Updated on 12 December 2021
corticosteroids
hydroxychloroquine
ds dna
belimumab
benlysta

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.

Description

This protocol proposes that early treatment of Systemic Lupus Erythematous (SLE) may prevent tissue damage and may even lead to long-term remission of disease. This concept is supported by reports of SLE-associated autoimmunity that are detected serologically many years prior to any constitutional symptoms or specific tissue inflammation and immune dysregulation precedes the development of clinically apparent SLE. Belimumab (Benlysta) is an FDA approved medication and is a monoclonal antibody directed against B cell-activating factor (BAFF)/ B Lymphocyte Stimulator (BLyS). B cells maturing in environments with high BAFF levels are more likely to be autoreactive B cells. This is a double-blind placebo controlled trial of belimumab, in patients with early lupus, ie lupus diagnosed within 2 years. Thirty subjects will be randomized (2:1) to receive subcutaneous belimumab weekly or placebo. After a year of treatment, subjects receiving belimumab will be rerandomized (1:1) to receive belimumab or placebo. The primary outcome is B cell autoreactivity. Clinical efficacy including disease activity, flares, attainment of low disease activity or remission as well as surrogate cardiovascular biomarkers will also be assessed.

Details
Condition Lupus Erythematosus, Systemic, Lupus Erythematosus
Treatment Placebo, belimumab, Belimumab/Placebo
Clinical Study IdentifierNCT03543839
SponsorNorthwell Health
Last Modified on12 December 2021

Eligibility

Yes No Not Sure

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
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, methotrexate, 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
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