RECRUITING

Trial of Belimumab in Early Lupus

Conditions

Lupus Erythematosus, Systemic Lupus Erythematosus lupus early lupus belimumab autoreactivity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Trial of Belimumab in Early Lupus

Quick Facts

Study Start:2020-09-15

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03543839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sanita Kandasami, BS

CONTACT

516 562-2401

skandasami@northwell.edu

Cynthia Aranow, MD

CONTACT

516 562-3845

caranow@northwell.edu

Principal Investigator

Cynthia Aranow, MD

PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research, Northwell Health

Study Locations (Sites)

Feinstein Institute

Manhasset, New York, 11030

United States

Collaborators and Investigators

Sponsor: Northwell Health

Cynthia Aranow, MD, PRINCIPAL_INVESTIGATOR, Feinstein Institute for Medical Research, Northwell Health

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

Study Start Date2020-09-15

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-09-15

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

lupus
early lupus
belimumab
autoreactivity

Additional Relevant MeSH Terms

Lupus Erythematosus, Systemic
Lupus Erythematosus