Last updated: 07/17/2024 15:36:33
Efficacy and Safety of Belimumab in Patients with Active Lupus NephritisBLISS-LN
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with primary efficacy renal response at Week 104
Timeframe: Week 104
Secondary outcomes:
Number of participants with a complete renal response at Week 104
Timeframe: Week 104
Number of participants with primary efficacy renal response at Week 52
Timeframe: Week 52
Number of participants who experienced adverse events
Timeframe: Up to 136 weeks
Time to death or renal-related event
Timeframe: Up to 104 weeks
Number of participants with ordinal renal response at Week 104
Timeframe: Week 104
Interventions:
Biological/vaccine: Placebo plus standard therapy
Biological/vaccine: Belimumab 10 mg/kg plus standard therapy
Drug: Standard therapy
Enrollment:
448
Observational study model:
Not applicable
Primary completion date:
2019-25-07
Time perspective:
Not applicable
Clinical publications:
Xueqing Yu, Nan Chen, Jun Xue, Chi Chiu Mok, Sang-Cheol Bae, Xiaomei Peng, Wei Chen, Hong Ren, Xiao Li, Kajohnsak Noppakun, Jennifer Gilbride, Yulia Green, Beulah Ji, Chang Liu, Anuradha Madan, Mohamed Okily, Chun-Hang Tang, David Roth .Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population.Am J Kidney Dis.2022;S0272-6386(22):00860-5
DOI: 10.1053/j.ajkd.2022.06.013
PMID: 36058429
Richard Furie, Brad H Rovin, Frederic Houssiau, Gabriel Contreras, YK Onno Teng, Paula Curtis, Yulia Green, Mohamed Okily, Anuradha Madan, David A. Roth. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022;
DOI: 10.2215/CJN.02520322
PMID: 36302567
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
GlaxoSmithKline
Study date(s)
July 2012 to March 2020
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Biopsy confirmed active lupus nephritis.
- Pregnant or nursing.
- On dialysis within the past year.
Inclusion and exclusion criteria
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.
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.
Trial location(s)
Location
GSK Investigational Site
San Leandro, California, United States, 94578
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-320
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18017
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1119ACN
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Gainsville, Florida, United States, 32610
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Jeju special Self-Governing Prov., South Korea, 690-767
Status
Study Complete
Location
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Status
Study Complete
Location
GSK Investigational Site
La Palma, California, United States, 90623
Status
Study Complete
Location
GSK Investigational Site
Lipa City, Batangas, Philippines, 4217
Status
Study Complete
Location
GSK Investigational Site
London, London, United Kingdom, E1 1BB
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Onalaska, Wisconsin, United States, 54650
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Tucumán, Argentina, CP 4000
Status
Study Complete
Location
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04039-901
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Suwon-si, Gyeonggi-do, South Korea, 16499
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-25-07
Actual study completion date
2020-12-03
Plain language summaries
Summary of results in plain language
Available language(s): Cebuano, Chinese (Hong Kong), Chinese (Taiwan), Czech, Dutch, Dutch (Belgium), French (Belgium), French, German, Hiligaynon, Hungarian, Korean, Portuguese (Latin America), Russian, Spanish (Argentina), Thai, Spanish (Mexico), Spanish, Spanish (United States), Tagalog, English, Spanish (Columbia)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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