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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

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Okawa Yasutoshi

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Okawa Yasutoshi

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

completed

July. 21, 2016

Interventional

randomized controlled trial double blind placebocontrol parallel assignment

treatment purpose

2

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

Pregnant or nursing.
Have received treatment with belimumab (BENLYSTA(Registered Trademark)) 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.

Both

Systemic Lupus Erythematosus

investigational material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material :

efficacy
Percentage of Participants With SLE Responder Index (SRI) Response at Week 52

safety
efficacy
pharmacokinetics
Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2
Percent Change From Baseline in ParentGA at Week 52
Percent Change From Baseline in PGA at Week 52
Percent Change From Baseline in SELENA SLEDAI at Week 52
Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52
Percent Change From Baseline in Proteinuria at Week 52
Percentage of Participants With a Sustained SRI Response
Percentage of Participants With a Sustained ParentGA Response
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss)
Area Under Curve of Belimumab at Steady State (AUC, ss)

+81-99-275-5553

Aug. 21, 2015