Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
BLISS-LN
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
2 other identifiers
interventional
448
21 countries
118
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
Longer than P75 for phase_3
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedStudy Start
First participant enrolled
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2020
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedMarch 19, 2021
February 1, 2021
7 years
July 10, 2012
June 17, 2020
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
Week 104
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.
From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Secondary Outcomes (6)
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104
Week 104
Double-blind Period: Percentage of Participants With PERR at Week 52
Week 52
Double-blind Period: Number of Participants With Time to Death or Renal Related Event
Up to Week 104
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
Week 104
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs
Up to Week 104
- +1 more secondary outcomes
Study Arms (2)
Placebo plus standard therapy
PLACEBO COMPARATORPlacebo 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.
Belimumab 10 mg/kg plus standard therapy
EXPERIMENTALBelimumab 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.
Interventions
Belimumab 10 mg/kg plus 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Human Genome Sciences Inc., a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (118)
GSK Investigational Site
La Palma, California, 90623, United States
GSK Investigational Site
San Leandro, California, 94578, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Gainesville, Florida, 32610, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Brooklyn, New York, 11203, United States
GSK Investigational Site
Great Neck, New York, 11021, United States
GSK Investigational Site
Manhasset, New York, 11030, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Columbus, Ohio, 43203, United States
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Bethlehem, Pennsylvania, 18017, United States
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Philadelphia, Pennsylvania, 19140, United States
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Charleston, South Carolina, 29425, United States
GSK Investigational Site
Onalaska, Wisconsin, 54650, United States
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Ciudad Autonoma Buenos Aires, Buenos Aires, 1425, Argentina
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, CP 4000, Argentina
GSK Investigational Site
Buenos Aires, C1119ACN, Argentina
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Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
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Córdoba, 5000, Argentina
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Mendoza, 5500, Argentina
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
GSK Investigational Site
Juiz de Fora, Minas Gerais, 36010-570, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
GSK Investigational Site
São Paulo, São Paulo, 04039-901, Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
GSK Investigational Site
Goiânia, 74110-120, Brazil
GSK Investigational Site
Lajeado, 95900-000, Brazil
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Salvador, 40050-410, Brazil
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Edmonton, Alberta, T6G 2B7, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Wuhan, Hubei, 430030, China
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Changsha, Hunan, 410008, China
GSK Investigational Site
Nanchang, Jiangxi, 330006, China
GSK Investigational Site
Shenyang, Liaoning, 110004, China
GSK Investigational Site
Chengdu, Sichuan, 610041, China
GSK Investigational Site
Beijing, 100029, China
GSK Investigational Site
Chongqing, 400038, China
GSK Investigational Site
Fuzhou, 350005, China
GSK Investigational Site
Guangzhou, 510080, China
GSK Investigational Site
Nanning, 530021, China
GSK Investigational Site
Shanghai, 200025, China
GSK Investigational Site
Shanghai, 200040, China
GSK Investigational Site
Shanghai, 200127, China
GSK Investigational Site
Shenzhen, 518035, China
GSK Investigational Site
Xi'an, China
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Bogotá, Colombia
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Olomouc, 775 20, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Prague, 128 50, Czechia
GSK Investigational Site
Cean Cedex 09, 14033, France
GSK Investigational Site
Créteil, 94010, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Paris, 75013, France
GSK Investigational Site
Strasbourg, 67091, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23538, Germany
GSK Investigational Site
Jena, Thuringia, 07740, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Göttingen, 37075, Germany
GSK Investigational Site
Hong Kong, Hong Kong
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Miskolc, 3526, Hungary
GSK Investigational Site
Szeged, 6725, Hungary
GSK Investigational Site
Guadalajara, Jalisco, 45040, Mexico
GSK Investigational Site
Morelia, Michoacán, 58260, Mexico
GSK Investigational Site
Cuernavaca, Morelos, 62170, Mexico
GSK Investigational Site
México, 7760, Mexico
GSK Investigational Site
México, D.F., 14080, Mexico
GSK Investigational Site
Groningen, 9728 NT, Netherlands
GSK Investigational Site
Leiden, 2333 ZA, Netherlands
GSK Investigational Site
Maastricht, 6229 HX, Netherlands
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Lipa City, Batangas, 4217, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Moscow, 125284, Russia
GSK Investigational Site
Orenburg, 460000, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Ufa, 450005, Russia
GSK Investigational Site
Busan, 49201, South Korea
GSK Investigational Site
Daejeon, 301-721, South Korea
GSK Investigational Site
Daejeon, 35233, South Korea
GSK Investigational Site
Jeju Special Self-Governing Prov., 690-767, South Korea
GSK Investigational Site
Jeonju, 561-712, South Korea
GSK Investigational Site
Seoul, 04763, South Korea
GSK Investigational Site
Seoul, 06273, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Suwon, 16247, South Korea
GSK Investigational Site
Suwon-si, Gyeonggi-do, 16499, South Korea
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 8035, Spain
GSK Investigational Site
Palma de Mallorca, 07010, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Vigo/ Pontevedra, 36200, Spain
GSK Investigational Site
Gueishan Township,Taoyuan County, 333, Taiwan
GSK Investigational Site
Kaohsiung City, 83301, Taiwan
GSK Investigational Site
Taichung, 40705, Taiwan
GSK Investigational Site
Khon Kaen, 40002, Thailand
GSK Investigational Site
Muang, 50200, Thailand
GSK Investigational Site
Rajathevee, 10400, Thailand
GSK Investigational Site
Saimai, 10220, Thailand
GSK Investigational Site
London, E1 1BB, United Kingdom
GSK Investigational Site
London, SE1 7EH, United Kingdom
Related Publications (6)
Anders HJ, Furie R, Malvar A, Zhao MH, Hiromura K, Weinmann-Menke J, Green Y, Jones-Leone A, Negrini D, Levy RA, Lightstone L, Tanaka Y, Rovin BH. Effect of belimumab on kidney-related outcomes in patients with lupus nephritis: post hoc subgroup analyses of the phase 3 BLISS-LN trial. Nephrol Dial Transplant. 2023 Nov 30;38(12):2733-2742. doi: 10.1093/ndt/gfad167.
PMID: 37463054DERIVEDSada K, Kurita N, Noma H, Matsuki T, Quasny H, Levy RA, Jones-Leone AR, Gairy K, Yajima N. MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT. Lupus Sci Med. 2022 Sep;9(1):e000746. doi: 10.1136/lupus-2022-000746.
PMID: 37017254DERIVEDFurie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.
PMID: 36302567DERIVEDYu X, Chen N, Xue J, Mok CC, Bae SC, Peng X, Chen W, Ren H, Li X, Noppakun K, Gilbride JA, Green Y, Ji B, Liu C, Madan A, Okily M, Tang CH, Roth DA. 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. 2023 Mar;81(3):294-306.e1. doi: 10.1053/j.ajkd.2022.06.013. Epub 2022 Sep 2.
PMID: 36058429DERIVEDRovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.
PMID: 34560137DERIVEDFurie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.
PMID: 32937045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
July 12, 2012
Primary Completion
July 25, 2019
Study Completion
March 12, 2020
Last Updated
March 19, 2021
Results First Posted
July 7, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.