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Monoclonal Antibodies

Belimumab for Pediatric Lupus (PLUTO Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria
Have active SLE disease (SELENA SLEDAI score ≥ 6)
Must not have
Have a planned surgical procedure
History of malignant neoplasm within the last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is testing a new drug for lupus in kids. They want to see if it's safe and works well.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Belimumab may cause side effects such as nausea, diarrhea, fever, stuffy nose and sore throat (nasopharyngitis), infusion reactions which could include pain or swelling where the IV is placed; allergic reactions; possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus according to ACR criteria.
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My lupus is currently active and severe.
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I am between 5 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery.
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I have not had cancer in the last 5 years.
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I haven't had B cell therapy or experimental treatments in the last year.
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I do not have any major health issues unrelated to my lupus.
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I have severe kidney disease due to lupus.
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I have an IgA deficiency.
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I have lupus affecting my brain or spinal cord.
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I have had a major organ transplant.
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I have been treated with belimumab (BENLYSTA®) before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With SLE Responder Index (SRI) Response at Week 52
Secondary study objectives
Area Under Curve of Belimumab at Steady State (AUC, ss)
Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+8 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,812 Previous Clinical Trials
8,382,155 Total Patients Enrolled
Human Genome Sciences Inc., a GSK CompanyIndustry Sponsor
13 Previous Clinical Trials
3,458 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,144,978 Total Patients Enrolled

Media Library

Belimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01649765 — Phase 2
Lupus Research Study Groups: Arm 2, Arm 1
Lupus Clinical Trial 2023: Belimumab Highlights & Side Effects. Trial Name: NCT01649765 — Phase 2
Belimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01649765 — Phase 2
~7 spots leftby Dec 2025
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