Belimumab for Pediatric Lupus

(PLUTO Trial)

Recruiting in Palo Alto (17 mi)

+28 other 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

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.

Exclusion Criteria

Pregnant or nursing

I am scheduled for surgery.

I have not had cancer in the last 5 years.

Participant Groups

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.

Group I: Arm 1 Experimental Treatment 1 Intervention

belimumab 10mg/kg IV monthly

Group II: Arm 2 Placebo Group 1 Intervention

Normal Saline IV monthly

Belimumab is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Benlysta for:

• Systemic lupus erythematosus (SLE)

🇪🇺 Approved in European Union as Benlysta for:

• Systemic lupus erythematosus (SLE)

🇨🇦 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

Research Locations Nearby Select from list below to view details:

GSK Investigational Site Augusta, GA

GSK Investigational Site Bronx, NY

GSK Investigational Site Cincinnati, OH

GSK Investigational Site Calgary, Canada

More Trial Locations

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

Human Genome Sciences Inc., a GSK Company Industry Sponsor

References