Trial of Belimumab in Early Lupus
This two year study will assess 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 Start (Actual) 15 September 2020
🗓️ Primary Completion (Estimated) August 2026
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Manhasset, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 April 2018
  • First Submitted that Met QC Criteria 31 May 2018
  • First Posted 1 June 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 February 2024
  • Last Update Posted 14 February 2024
  • Last Verified February 2024