NCT03312907

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

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-05-29
• Completion: 2021-07-07
• First posted: 2017-10-18
• Last updated: 2025-02-18
• Results posted: 2022-04-25

Locations

79 sites across 11 countries: United States, Argentina, Brazil, Canada, France, Germany, Mexico, Netherlands, Russia, South Korea, Spain

Regulatory

• FDA-regulated drug study