Trial of Belimumab in Early Lupus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03543839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwell Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Cynthia Aranow, MD
Principal Investigator Affiliation Feinstein Institute for Medical Research, Northwell Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Erythematosus, Systemic, Lupus Erythematosus
Additional Details

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.

Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Feinstein Institute, Manhasset, New York

Status

Address

Feinstein Institute

Manhasset, New York, 11030