Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)
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Purpose
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Biological: Placebo plus standard therapy Biological: Belimumab 10 mg/kg plus standard therapy Drug: Standard therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Number of participants with a renal response at Week 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Number of participants with a complete renal response at Week 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Number of participants with a renal response at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Number of participants who experienced adverse events [ Time Frame: up to 136 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 464 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo plus standard therapy
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
|
Biological: Placebo plus standard therapy
Placebo plus standard therapy
Drug: Standard therapy
The standard therapies allowed in this study are: - High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR - High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy |
|
Experimental: Belimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
|
Biological: Belimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Other Name: BENLYSTA™
Drug: Standard therapy
The standard therapies allowed in this study are: - High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR - High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy |
Detailed Description:
Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts within 2 weeks before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Biopsy confirmed active lupus nephritis.
- Autoantibody-positive.
Key Exclusion Criteria:
- Pregnant or nursing.
- On dialysis within the past year.
- Prior treatment with belimumab.
- Receipt of any induction therapy within the past 6 months.
- 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.
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Show 42 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT01639339 History of Changes |
| Other Study ID Numbers: | 114054, HGS1006-C1121, 2011-004570-28 |
| Study First Received: | July 10, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Brazil: National Health Surveillance Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Korea: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Belgium: Federal Agency for Medicinal Products and Health Products Spain: Agencia Española de Medicamentos y Productos Sanitarios Hungary: National Institute of Pharmacy Thailand: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Taiwan: Department of Health Philippines: Bureau of Food and Drugs Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Mexico: Ministry of Health Russia: Ministry of Health of the Russian Federation |
Keywords provided by GlaxoSmithKline:
|
Antibodies Systemic Lupus Erythematosus Autoimmune Disease Glomerulonephritis Belimumab |
Lupus Nephritis Kidney Diseases SLE |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013