Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Lupus Nephritis

Treatments: Biological: Belimumab 10 mg/kg plus standard therapy; Drug: Standard therapy; Biological: Placebo plus standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639339

114054

2011-004570-28 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 2 patient groups, including a placebo group

Placebo plus standard therapy

Placebo Comparator group

Description:

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Treatment:

Drug: Standard therapy

Biological: Placebo plus standard therapy

Belimumab 10 mg/kg plus standard therapy

Experimental group

Description:

Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Treatment:

Biological: Belimumab 10 mg/kg plus standard therapy

Drug: Standard therapy