Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT01649765

Run by

GlaxoSmithKline

People needed

93

Starts

2012-09-07

Expected to finish

2025-09-30

Last updated by the study team

2026-04-20

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Rosario, Argentina
• GSK Investigational Site — Santa Fe, Argentina
• GSK Investigational Site — Calgary, Alberta, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Aichi, Japan
• GSK Investigational Site — Kagoshima, Japan
• GSK Investigational Site — Miyagi, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — San Luis Potosí City, Mexico
• GSK Investigational Site — Lima, Peru
• GSK Investigational Site — Lima, Peru
• GSK Investigational Site — Surco, Peru
• GSK Investigational Site — Lodz, Poland
• GSK Investigational Site — Warsaw, Poland
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Tolyatti, Russia

Full record on ClinicalTrials.gov

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