Last updated: 07/17/2024 15:36:57
Pediatric Lupus trial of belimumab plus background standard therapyPLUTO
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with SLE Responder Index (SRI) response at Week 52
Timeframe: Week 52
Secondary outcomes:
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
Timeframe: Week 52
Percent change from Baseline in ParentGA at Week 52
Timeframe: Baseline (Day 0) and Week 52
Percent change from Baseline in PGA at Week 52
Timeframe: Baseline (Day 0) and Week 52
Percent change from Baseline in SELENA SLEDAI at Week 52
Timeframe: Baseline (Day 0) and Week 52
Percent change from Baseline in PedsQL Physical Functioning Domain Score at Week 52
Timeframe: Baseline (Day 0) and Week 52
Percent change from Baseline in proteinuria at Week 52
Timeframe: Baseline (Day 0) and Week 52
Percentage of participants with a sustained SRI response
Timeframe: Up to 52 weeks
Percentage of participants with a sustained ParentGA response
Timeframe: Up to 52 weeks
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 60 weeks
Maximum concentration at steady state (Cmax, ss) and minimum concentration at steady state (Cmin, ss)
Timeframe: 28-days dosing interval at steady state
Area under curve of Belimumab at steady state (AUC, ss)
Timeframe: 28-days dosing interval at steady state
Interventions:
Enrollment:
93
Primary completion date:
2018-24-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
HI Brunner, C Abud Mendoza, DO Viola, I Calvo Penades, DM Levy, J Anton, JE Calderon, VG Chasnyk, MA Ferrandiz, VA Keltsev, ME Paz Gastanaga, M Shishov, AL Boteanu, M Henrickson, D Bass, K Clark, A Hammer, B Ji, A Nino, DA Roth, H Struemper, M-L Wang, A Martini, DJ Lovell, N Ruperto. The safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: Results from a randomised, placebo-controlled trial. Ann Rheum Dis. 2020;
DOI: 10.1136/annrheumdis-2020-217101
PMID: 32699034
Hermine Brunner, Carlos Abud-Mendoza, Masaaki Mori, Clarissa Pilkington, Reema Syed, Syuij Takei, Diego Viola, Richard Furie, Sandra Navarra, Fengchun Zhang, Damon Bass, Gina Eriksson, Anne Hammer, Beulah Ji, Mo Okily, David Roth, Holly Quasny, Nicolino Ruperto.Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison.RMD Open.2021;7(e001747)
DOI: 10.1136/rmdopen-2021-001747
PMID: 34531304
Xuan Zhou, Tsung-I Lee, Min Zhu, Peiming Ma.Prediction of Belimumab Pharmacokinetics to Chinese Pediatric Patients with Systemic Lupus Erythematosus.Drugs R D.2021;
DOI: 10.1007/s40268-021-00363-2
PMID: 34628605
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Human Genome Sciences Inc., a GSK Company
Study date(s)
September 2012 to December 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 17 years
Accepts healthy volunteers
No
- 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.
- Pregnant or nursing.
- Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.)
Inclusion and exclusion criteria
Inclusion criteria:
- 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
5 years to 17 years of age at enrollment
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.
Trial location(s)
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Esplugues de Llobregat. Barcelona, Spain, 08950
Status
Unmapped
Showing 1 - 6 of 32 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Recruitment complete
Actual primary completion date
2018-24-01
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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