Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Human Genome Sciences

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Belimumab 100 mg SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00732940

HGS1006-1070

112232 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Full description

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
• Active SLE disease
• On stable SLE treatment regimen

Exclusion criteria

• Pregnant or nursing
• Have received treatment with an B cell targeted therapy
• Have received treatment with a biologic investigational agent in the past year
• Have received intravenous (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 with the past 60 days
• Have current drug or alcohol abuse or dependence or within the past year
• Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Belimumab Q2WKS

Experimental group

Description:

Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

Treatment:

Drug: Belimumab 100 mg SC

Drug: Belimumab 100 mg SC

Belimumab 3X/WK

Experimental group

Description:

Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

Treatment:

Drug: Belimumab 100 mg SC

Drug: Belimumab 100 mg SC