Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

• Status: Completed
• Trial end date: 2020-03-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Belimumab

Criteria

Key Inclusion Criteria:

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

• Biopsy confirmed active lupus nephritis.

• Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.

• Autoantibody-positive.

Key Exclusion Criteria:

• Pregnant or nursing.

• On dialysis within the past year.

• Treatment with belimumab within the past year .

• Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.

• Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.

• Severe active central nervous system (CNS) lupus.

• Required management of acute or chronic infections within the past 60 days.

• Current drug or alcohol abuse or dependence.

• Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

• History of severe allergic reaction to contrast agents or biological medicines.