Compassionate Use for Subcutaneous (SC) Belimumab

N/ANo Longer AvailableNCT03125486

GlaxoSmithKline

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Systemic Lupus Erythematosus

Interventions

SC belimumab 200 mgDRUG

Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Milwaukee, Wisconsin, United States

Data from ClinicalTrials.gov

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