Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2022
• Main ID: NCT01649765
• Date of registration: 23/07/2012
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy PLUTO
• Scientific title: 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
• Date of first enrolment: September 7, 2012
• Target sample size: 93
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01649765
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Canada, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 5 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: belimumab 10mg/kg

Other: placebo

Primary Outcome(s)

Percentage of Participants With SLE Responder Index (SRI) Response at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Area Under Curve of Belimumab at Steady State (AUC, ss) [Time Frame: 28-days dosing interval at steady state]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to 60 weeks]

Percent Change From Baseline in PGA at Week 52 [Time Frame: Baseline (Day 0) and Week 52]

Percent Change From Baseline in SELENA SLEDAI at Week 52 [Time Frame: Baseline (Day 0) and Week 52]

Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss) [Time Frame: 28-days dosing interval at steady state]

Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52 [Time Frame: Baseline (Day 0) and Week 52]

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 [Time Frame: Week 52]

Percentage of Participants With a Sustained SRI Response [Time Frame: Up to 52 weeks]

Percent Change From Baseline in ParentGA at Week 52 [Time Frame: Baseline (Day 0) and Week 52]

Percentage of Participants With a Sustained ParentGA Response [Time Frame: Up to 52 weeks]

Percent Change From Baseline in Proteinuria at Week 52 [Time Frame: Baseline (Day 0) and Week 52]

Secondary ID(s)

2011-000368-88

114055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Human Genome Sciences Inc., a GSK Company

Results

• Results available: Yes
• Date Posted: 15/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01649765