Compassionate Use for Subcutaneous (SC) Belimumab

GlaxoSmithKline (GSK)

Status

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: SC belimumab 200 mg

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03125486

207616

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab).

Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use:

• The illness being treated is life threatening or seriously debilitating.
• There are no satisfactory alternative treatments (confirmed by the HCP).
• There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.