Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

• Status: Active, not recruiting
• Trial end date: 2028-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Human Genome Sciences Inc., a GSK Company
• Treatments: Belimumab

Criteria

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.