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
Study complete
Study complete
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:
Enrollment:
448
Primary completion date:
2019-25-07
Observational study model:
Not applicable
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
Showing 1 - 6 of 115 Results
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
Study complete
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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