Belimumab for Lupus

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called belimumab, given as an injection under the skin, in children with lupus. The goal is to see if it is safe and effective by calming down their overactive immune systems. Belimumab is approved for the treatment of lupus in adults with moderate disease activity.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for children aged 5 to 17 with Systemic Lupus Erythematosus (SLE) who weigh at least 15 kg. They should have active SLE, positive autoantibody test results, and be on a stable treatment regimen for at least 30 days prior to the start of the study. Participants must not be pregnant or breastfeeding and agree to use effective contraception.

Inclusion Criteria

No contraceptive measures are required for male participants.

I meet at least 4 of the criteria for lupus.

I am either male or female.

Exclusion Criteria

I have severe kidney inflammation that might need treatment in the first 12 weeks of the trial.

I am on medication for a long-term infection like TB or herpes.

I've needed 3 or more steroid treatments for another condition in the last 3 months.

Treatment Details

Interventions

• Belimumab (Monoclonal Antibodies)

Trial Overview The trial tests subcutaneous injections of Belimumab in pediatric patients with SLE. It aims to understand how the drug behaves in their bodies (pharmacokinetics), its safety profile, and how it affects disease activity (pharmacodynamics). The study includes an initial 12-week treatment phase followed by an optional 40-week continuation.

Participant Groups

Group I: Belimumab 200 mg Experimental Treatment 1 Intervention

Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

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)

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