Lupus > Belimumab

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.

Eligibility Criteria

Inclusion Criteria

Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.

Participant's age is 5 to 17 years at the time of informed consent.

Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening (SELENA SLEDAI scoring).

Participant Groups

Group I: Pediatric participants receiving belimumab Experimental Treatment 2 Interventions

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:

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

References