A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

Summary

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

Conditions

• Systemic Lupus Erythematosus

Interventions

DRUG

Belimumab

Belimumab will be administered as SC injection once weekly via autoinjector in thigh or abdomen

DRUG

Rituximab

Rituximab will be administered as IV infusion of 1000mg at Week 4 and Week 6

DRUG

Rituximab-placebo

Saline will be administered as IV infusions at Week 4 and Week 6

DRUG

Standard therapy (Including Immunosuppressants)

Standard therapy will contain stable SLE medications including immunosuppressant to be administered from baseline through Week 104.

DRUG

Standard therapy (Excluding Immunosuppressants)

Standard therapy excluding Immunosuppressant will contain anti-malarials, NSAIDs, and/or corticosteroids with prednisone dose equivalent to \<= 5 mg/day will administered through Week 104.

DRUG

Steroid Taper

Steroid taper will include prednisone doses equivalent to =\< 5 mg/day in all Arms through Week 104.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2020-05-29

Completion

2021-07-07

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• Canada
• France
• Germany
• Mexico
• Netherlands
• Russia
• South Korea
• Spain

Study Locations