Compassionate Use for Subcutaneous (SC) Belimumab

NCT03125486 | Unknown

• 1 other identifier: 207616
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

subcutaneous Belimumab; Individual Patient Compassionate Use; SLE; GSK1550188

Interventions

SC belimumab 200 mg DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 24, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)