Phase 3
N=448
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Lupus Nephritis
Bottom Line
View on ClinicalTrials.gov: NCT01639339 ↗Enrolled (actual)
448
Serious AEs
22.5%
Results posted
Jul 2020
Primary outcome: Primary: Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 — 32.3; 43.0 Percentage of participants — p=0.0311
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo plus standard therapy (Biological); Belimumab 10 mg/kg plus standard therapy (Biological); Standard therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Human Genome Sciences Inc., a GSK Company
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 |
32.3; 43.0 | 0.0311 sig |
| PRIMARY Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) |
76; 92; 5; 10 | — |
| PRIMARY Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) |
0; 0; 0; 0; 4; 5 | — |
| SECONDARY Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104 |
19.7; 30.0 | 0.0167 sig |
| SECONDARY Double-blind Period: Percentage of Participants With PERR at Week 52 |
35.4; 46.6 | 0.0245 sig |
| SECONDARY Double-blind Period: Number of Participants With Time to Death or Renal Related Event |
63; 35 | 0.0014 sig |
| SECONDARY Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 |
19.7; 30.0; 17.0; 17.5; 63.2; 52.5 | 0.0096 sig |
| SECONDARY Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs |
211; 214; 67; 58 | — |
| SECONDARY Double-blind Period: Number of Participants Reporting AESI |
0; 2; 0; 3; 29; 26 | — |
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Biopsy confirmed active lupus nephritis.
- Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
- Autoantibody-positive.
Key Exclusion Criteria
- Pregnant or nursing.
- On dialysis within the past year.
- Treatment with belimumab within the past year .
- Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy 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.
Data sourced from ClinicalTrials.gov (NCT01639339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.