Phase 3
N=836
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01484496 ↗Enrolled (actual)
836
Serious AEs
9.6%
Results posted
Jul 2017
Primary outcome: Primary: Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 — 48.4; 61.4 Percentage of par. — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Biological); Belimumab 200 mg SC (Biological); Standard therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Human Genome Sciences Inc., a GSK Company
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 |
48.4; 61.4 | 0.0006 sig |
| SECONDARY Time to First Severe Flare (as Measured by the Modified SLE Flare Index) |
118; 171 | 0.0004 sig |
| SECONDARY Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline |
11.9; 18.2 | 0.0732 |
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age.
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Exclusion Criteria
- Pregnant or nursing.
- Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
- Have received treatment an investigational biological agent in the past year.
- Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a history of hypersensitivity reactions to contrast agents or biological medicines.
Data sourced from ClinicalTrials.gov (NCT01484496). 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.