Evaluating belimumab for early lupus treatment
Pilot Trial of Belimumab in Early Lupus
This study is testing if the drug belimumab can help people who have been diagnosed with lupus in the last two years feel better and possibly stay in remission.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | rituximab, belimumab, methotrexate, cyclophosphamide |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT03543839 on ClinicalTrials.gov |
What this trial studies
This two-year study investigates the effects of belimumab (Benlysta) on patients diagnosed with early lupus, defined as lupus diagnosed within the last two years. Participants will be randomly assigned to receive either belimumab or a placebo for the first year, followed by a rerandomization for those on belimumab to continue or switch to placebo in the second year. The study aims to assess clinical outcomes, immune system effects, and the potential for long-term remission by targeting autoreactive B cells. The primary focus is on B cell autoreactivity, alongside evaluating disease activity and cardiovascular biomarkers.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with systemic lupus erythematosus within the last two years who meet specific serological and disease activity criteria.
Not a fit: Patients who have previously been treated with disease-modifying drugs or biologics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved management of early lupus and potentially prevent long-term tissue damage.
How similar studies have performed: Other studies have shown promise in early intervention for lupus, but this specific approach with belimumab is relatively novel.
Eligibility criteria
Show full 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. * 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
Where this trial is running
Manhasset, New York
- Feinstein Institute — Manhasset, New York, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia Aranow, MD — Feinstein Institute for Medical Research, Northwell Health
- Study coordinator: Sanita Kandasami, BS
- Email: skandasami@northwell.edu
- Phone: 516 562-2401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.