drugset / Trial / NCT03125486

Compassionate Use for Subcutaneous (SC) Belimumab

NCT03125486

Expanded access No longer available GlaxoSmithKline

Summary

GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Background Belimumab Monoclonal antibody 200 mg Subcutaneous