Compassionate Use for Subcutaneous (SC) Belimumab

NO_LONGER_AVAILABLE

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT03125486

Run by

GlaxoSmithKline

Last updated by the study team

2018-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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