Can a lupus drug help when given early?
NCT ID NCT03543839
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests the drug belimumab (Benlysta) in 30 people who were diagnosed with lupus within the last two years. Participants will receive either the drug or a placebo for one year, and then some may switch to placebo in the second year. The goal is to see if early treatment can control the disease and change how the immune system behaves.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belimumab (Benlysta)
- What this could lead to
- If it works, this could point toward a treatment that controls lupus early on, potentially reducing long-term damage.
- What could go wrong
- This is a small pilot trial with only 30 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects like infections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Feinstein Institute
RECRUITINGManhasset, New York, 11030, United States
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