A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus

114055

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

2012-09-07

2018-01-24

2028-04-05

Active (not recruiting)

Early phase I

93

Inclusion Criteria: * 5 years to 17 years of age at enrollment * Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. * Have active SLE disease (SELENA SLEDAI score ≥ 6). * Have positive anti-nuclear antibody (ANA) test results. * Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0. * Females of childbearing age are willing to use appropriate contraception * Subject age appropriate assent and parent or legal guardian informed consent to participate Exclusion Criteria: * Pregnant or nursing. * Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.) * Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year. * Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0. * Have received high dose prednisone or equivalent (\>1.5mg/kg/day) within 60 days of baseline. * Have received intravenous (IV) cyclophosphamide within 60 days of Day 0. * Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline. * Have severe lupus kidney disease. * Have active central nervous system (CNS) lupus. * Have had a major organ transplant. * Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE. * Have a planned surgical procedure. * History of malignant neoplasm within the last 5 years. * Have required management of acute or chronic infections in the past 60 days. * Have current drug or alcohol abuse or dependence. * Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C. * Have an IgA deficiency. * Have severe laboratory abnormalities. * Have had anaphylactic reaction to X-ray contrast agents or biologic agents. * Suicidal behavior or ideation. * Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 93, 'type': 'ACTUAL'}}

2022-11-16