Efficacy and Safety of Belimumab in SLE Patients

NCT04515719 | Completed Phase 4

• 1 other identifier: Btrial
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Belimumab; Systemic Lupus Erythematosus; Disease flare

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with disease flares

  Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

  52 weeks

Secondary Outcomes (8)

• Percentage of patients with mild/moderate flares

  52 weeks

• Percentage of patients with major flares

  52 weeks

• Time to first disease flare

  52 weeks

• prednisone dose at each visit

  52 weeks

• SELENA-SLEDAI score at each visit

  52 weeks

Other Outcomes (1)

• Subgroup analysis

  52 weeks

Study Arms (2)

Belimumab 2mg/kg

EXPERIMENTAL

Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.

Biological: Belimumab

Placebo

PLACEBO COMPARATOR

Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.

Biological: Placebo

Interventions

Belimumab BIOLOGICAL

Belimumab 2mg/kg intravenously

Also known as: BENLYSTA™

Belimumab 2mg/kg

Placebo BIOLOGICAL

Placebo intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years;
• Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
• A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
• Sign the informed consent;

You may not qualify if:

• Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits;
• Creatinine clearance rate \< 60ml/min;
• Exposure to cyclophosphamide within past 6 months before screening;
• Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
• History of Malignancy;
• History of herpes zoster with past 3 months before screening.
• Chronic HBV/HCV hepatitis；
• Current infections (HIV/tuberculosis)

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shuang Ye, MD

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

• Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, Leon MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.

  PMID: 21296403 BACKGROUND

• Sun F, Wang H, Zhang D, Shen N, Chen S, Li T, Wan W, Dai SM, Ye S. Low-dose belimumab reduced risk of flares in patients with systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2025 Nov 6:S0003-4967(25)04449-8. doi: 10.1016/j.ard.2025.10.010. Online ahead of print.

  PMID: 41203461 DERIVED

• Sun F, Huang W, Chen J, Zhao L, Zhang D, Wang X, Wan W, Dai SM, Chen S, Li T, Ye S. Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. Lupus Sci Med. 2022 Feb;9(1):e000638. doi: 10.1136/lupus-2021-000638.

  PMID: 35105722 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: March 10, 2021
• Primary Completion: April 10, 2022
• Study Completion: April 10, 2022
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)