Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis - BLISS-LN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004570-28-GB

Enrollment

464

Registered

2012-08-20

Start date

2012-10-12

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis MedDRA version: 20.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Belimum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. •Biopsy confirmed active lupus nephritis. •Autoantibody-positive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 455 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9

Exclusion criteria

Exclusion criteria: •Pregnant or nursing. •On dialysis within the past year. •Prior treatment with belimumab within the past year like what in the B cell targeted therapy. •Receipt of any induction therapy with CYC within 3 months prior to the planned initiation of the current induction for the study. •Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year. •Severe active central nervous system (CNS) lupus. •Required management of acute or chronic infections within the past 60 days. •Current drug or alcohol abuse or dependence. •Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. •History of severe allergic reaction to contrast agents or biological medicines.

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.;Secondary Objective: not applicable;Primary end point(s): Primary Outcome Measure: • Number of participants with Primary Efficacy Renal Response (PERR) at Week 104;Timepoint(s) of evaluation of this end point: Please refer to point E.5.1	—

Secondary

Measure	Time frame
Secondary end point(s): Major Secondary Endpoints: Complete Renal Response (CRR) at Week 104 (see definition under Ordinal Renal Response). • PERR at Week 52. • Time to Death or Renal-related Event defined as any of the following: i) end stage renal disease (ESRD), ii) doubling of serum creatinine, iii) renal worsening as evidenced by increased proteinuria and/or impaired renal function, or iv) renal disease-related treatment failure • Ordinal Renal Response (ORR; complete, partial or no response) at Week 104 defined as follows: • Complete Renal Response (CRR): Estimated glomerular filtration rate (GFR) is no more than 10% below the pre-flare value or within normal range AND Urinary protein:creatinine ratio 3.0 AND - No receipt of prohibited (rescue) therapy resulting in treatment failure (see Section5.5 and Section 5.6). • No Renal Response (NRR): Not meeting criteria for either CRR or PRR.;Timepoint(s) of evaluation of this end point: please refer to point E.5.2	—

Measure

Time frame

Secondary end point(s): Major Secondary Endpoints: Complete Renal Response (CRR) at Week 104 (see definition under Ordinal Renal Response). • PERR at Week 52. • Time to Death or Renal-related Event defined as any of the following: i) end stage renal disease (ESRD), ii) doubling of serum creatinine, iii) renal worsening as evidenced by increased proteinuria and/or impaired renal function, or iv) renal disease-related treatment failure • Ordinal Renal Response (ORR; complete, partial or no response) at Week 104 defined as follows: • Complete Renal Response (CRR): Estimated glomerular filtration rate (GFR) is no more than 10% below the pre-flare value or within normal range AND Urinary protein:creatinine ratio 3.0 AND - No receipt of prohibited (rescue) therapy resulting in treatment failure (see Section5.5 and Section 5.6). • No Renal Response (NRR): Not meeting criteria for either CRR or PRR.;Timepoint(s) of evaluation of this end point: please refer to point E.5.2

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Countries

Argentina, Belgium, Brazil, Canada, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Korea, Republic of, Mexico, Netherlands, Philippines, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactClinical Trials Information Center

GlaxoSmithKline Research & Development Ltd.

GSKClinicalSupportHD@gsk.com44208990 4466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026