A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Placebo; Drug: Standard therapy; Biological: Belimumab 200 mg SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484496

HGS1006-C1115

112341

2011-003814-18

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Full description

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Enrollment: 839 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 18 years of age.
2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
3. Active SLE disease.
4. Autoantibody-positive.
5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion criteria

1. Pregnant or nursing.
2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
3. Have received treatment an investigational biological agent in the past year.
4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
5. Have severe active lupus kidney disease.
6. Have severe active central nervous system (CNS) lupus.
7. Have required management of acute or chronic infections within the past 60 days.
8. Have current drug or alcohol abuse or dependence.
9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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839 participants in 2 patient groups, including a placebo group

Placebo plus standard therapy

Placebo Comparator group

Description:

Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.

Treatment:

Drug: Standard therapy

Biological: Placebo

Belimumab 200 mg SC plus standard therapy

Experimental group

Description:

Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.

Treatment:

Biological: Belimumab 200 mg SC

Drug: Standard therapy