NCT04515719

Efficacy and Safety of Belimumab in SLE Patients

Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Detailed description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab	Belimumab 2mg/kg intravenously
BIOLOGICAL	Placebo	Placebo intravenously

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-04-10
• Completion: 2022-04-10
• First posted: 2020-08-17
• Last updated: 2025-05-14

Locations

1 site across 1 country: China