Belimumab for Pediatric Lupus
(PLUTO Trial)
Recruiting at 28 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: GlaxoSmithKline
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
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
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for children aged 5-17 with active systemic lupus erythematosus (SLE), meeting specific criteria. They must have a positive ANA test, an SELENA SLEDAI score ≥ 6, and be on stable SLE treatment for at least 30 days. Girls able to have babies must agree to use birth control. Kids can't join if they've had certain treatments like belimumab or rituximab, recent high-dose steroids or IV cyclophosphamide, severe kidney disease from lupus, major organ transplants, certain infections or diseases not from SLE.Inclusion Criteria
I, or my child, have agreed to participate and a parent or guardian has given consent.
I am willing to use birth control.
I have been on a steady lupus treatment for at least 30 days.
See 4 more
Exclusion Criteria
Pregnant or nursing
I am scheduled for surgery.
I have not had cancer in the last 5 years.
See 18 more
Treatment Details
Interventions
- Belimumab (Monoclonal Antibodies)
Trial OverviewThe study tests the safety and effectiveness of belimumab (an intravenous medication) in kids with lupus compared to a placebo. Belimumab will be given alongside standard therapies that participants are already using for their condition.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
belimumab 10mg/kg IV monthly
Group II: Arm 2Placebo Group1 Intervention
Normal Saline IV monthly
Belimumab is already approved in Canada, Japan for the following indications:
Approved in Canada as Benlysta for:
- Systemic lupus erythematosus (SLE)
Approved in Japan as Benlysta for:
- Systemic lupus erythematosus (SLE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Human Genome Sciences Inc., a GSK Company
Industry Sponsor
Trials
14
Recruited
3,600+