A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

Human Genome Sciences

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Belimumab 1 mg/kg; Drug: Belimumab 10 mg/kg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410384

110751 (Other Identifier)

BLISS-76

HGS1006-C1056

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Enrollment: 819 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Clinical diagnosis of SLE by ACR criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen.

Key Exclusion Criteria:

• Pregnant or nursing
• Have received treatment with any B cell targeted therapy.
• Have received treatment with a biological investigational agent in the past year.
• Have received IV cyclophosphamide within 180 days of Day 0.
• Have severe lupus kidney disease.
• Have active central nervous system (CNS) lupus.
• Have required management of acute or chronic infections within the past 60 days.
• Have current drug or alcohol abuse or dependence.
• Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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819 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Belimumab 1 mg/kg

Experimental group

Description:

Belimumab 1 mg/kg

Treatment:

Drug: Belimumab 1 mg/kg

Belimumab 10 mg/kg

Experimental group

Description:

Belimumab 10 mg/kg

Treatment:

Drug: Belimumab 10 mg/kg