A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
BLISS-SC
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
3 other identifiers
interventional
839
30 countries
205
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Typical duration for phase_3
205 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
Study Start
First participant enrolled
November 16, 2011
CompletedFirst Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
July 25, 2017
CompletedJune 6, 2018
May 1, 2018
3.2 years
November 28, 2011
January 30, 2017
May 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of \<0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Week 52
Secondary Outcomes (2)
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Baseline (Day 0, prior to dosing) to Week 52
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
Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
Study Arms (2)
Placebo plus standard therapy
PLACEBO COMPARATORPlacebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Belimumab 200 mg SC plus standard therapy
EXPERIMENTALBelimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Interventions
Belimumab 200 mg SC
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Human Genome Sciences Inc., a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (207)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Peoria, Arizona, 85381, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
La Jolla, California, 92037-0943, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Francisco, California, 94118, United States
GSK Investigational Site
San Jose, California, 95126-1650, United States
GSK Investigational Site
San Leandro, California, 94578, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Bridgeport, Connecticut, 06606, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Boca Raton, Florida, 33432, United States
GSK Investigational Site
Boca Raton, Florida, 33486, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33334, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Orlando, Florida, 32806-6264, United States
GSK Investigational Site
Plantation, Florida, 33324, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
Atlanta, Georgia, 30303, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Duluth, Georgia, 30096, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Boise, Idaho, 83704, United States
GSK Investigational Site
Springfield, Illinois, 62704, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70809, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
Baltimore, Maryland, 21205, United States
GSK Investigational Site
Cumberland, Maryland, 21502, United States
GSK Investigational Site
Hagerstown, Maryland, 21740, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Saint Clair Shores, Michigan, 48081, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Las Cruces, New Mexico, 88011, United States
GSK Investigational Site
Brooklyn, New York, 11203, United States
GSK Investigational Site
Lake Success, New York, 11042, United States
GSK Investigational Site
Manhasset, New York, 11030, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Smithtown, New York, 11787, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7280, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Charlotte, North Carolina, 28210, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
Columbus, Ohio, 43203, United States
GSK Investigational Site
Dayton, Ohio, 45417, United States
GSK Investigational Site
Toledo, Ohio, 43614, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Bethlehem, Pennsylvania, 18015, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Greenville, South Carolina, 29601, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Jackson, Tennessee, 38305, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77008, United States
GSK Investigational Site
Houston, Texas, 77034, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Nassau Bay, Texas, 77058, United States
GSK Investigational Site
Royalty, Texas, 75013, United States
GSK Investigational Site
Arlington, Virginia, 22205-3606, United States
GSK Investigational Site
Seattle, Washington, 98133, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Pennsylvania, Wyoming, 19610, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACI, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN, Argentina
GSK Investigational Site
La Plata, Buenos Aires, B1902COS, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1426AAL, Argentina
GSK Investigational Site
Vienna, A-1100, Austria
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Cuiabá, Mato Grosso, 78005-000, Brazil
GSK Investigational Site
Juiz de Fora, Minas Gerais, 36038-330, Brazil
GSK Investigational Site
Curitiba, Paraná, 80440-080, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
GSK Investigational Site
Rio de Janeiro, 21941-913, Brazil
GSK Investigational Site
Salvador, 40050-410, Brazil
GSK Investigational Site
São Paulo, 04032-060, Brazil
GSK Investigational Site
Plovdiv, 4002, Bulgaria
GSK Investigational Site
Rousse, 7002, Bulgaria
GSK Investigational Site
Sofia, 1784, Bulgaria
GSK Investigational Site
Santiago, Región Metro de Santiago, 7501126, Chile
GSK Investigational Site
Santiago, 7500000, Chile
GSK Investigational Site
Viña del Mar, 2570017, Chile
GSK Investigational Site
Barranquilla, Colombia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Bucaramanga, Colombia
GSK Investigational Site
Medellín, Colombia
GSK Investigational Site
Osijek, 31000, Croatia
GSK Investigational Site
Rijeka, 51000, Croatia
GSK Investigational Site
Zagreb, 10000, Croatia
GSK Investigational Site
Prague, 128 50, Czechia
GSK Investigational Site
Zlín, 760 01, Czechia
GSK Investigational Site
Copenhagen, 2100, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Paris, 75679, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Suresnes, 92150, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Würzburg, Bavaria, 97080, Germany
GSK Investigational Site
Bad Nauheim, Hesse, 61231, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Frankfurt, 60590, Germany
GSK Investigational Site
Hamburg, 22081, Germany
GSK Investigational Site
Debrecen, 4032, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Pisa, Tuscany, 56126, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Genova, 16132, Italy
GSK Investigational Site
Fukuoka, 807-8555, Japan
GSK Investigational Site
Fukuoka, 810-8563, Japan
GSK Investigational Site
Hokkaido, 060-8604, Japan
GSK Investigational Site
Hokkaido, 060-8648, Japan
GSK Investigational Site
Miyagi, 980-8574, Japan
GSK Investigational Site
Nagasaki, 857-1195, Japan
GSK Investigational Site
Okinawa, 901-0243, Japan
GSK Investigational Site
Shizuoka, 430-8558, Japan
GSK Investigational Site
Tokyo, 104-8560, Japan
GSK Investigational Site
Tokyo, 160-8582, Japan
GSK Investigational Site
Tokyo, 162-8655, Japan
GSK Investigational Site
Kuala Lumpur, 59100, Malaysia
GSK Investigational Site
Seremban, Negeri Sembilan, 70300, Malaysia
GSK Investigational Site
Guadalajara, Jalisco, 44158, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44690, Mexico
GSK Investigational Site
Cuernavaca, Morelos, 62270, Mexico
GSK Investigational Site
Mérida, Yucatán, 97130, Mexico
GSK Investigational Site
México, 06700, Mexico
GSK Investigational Site
México, 3100, Mexico
GSK Investigational Site
San Luis Potosí City, 78240, Mexico
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Las Piñas, 1740, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Manila, 1015, Philippines
GSK Investigational Site
Quezon City, 1102, Philippines
GSK Investigational Site
Quezon City, 1118, Philippines
GSK Investigational Site
Bydgoszcz, 85-168, Poland
GSK Investigational Site
Katowice, 40-635, Poland
GSK Investigational Site
Krakow, 31-066, Poland
GSK Investigational Site
Wroclaw, 50-556, Poland
GSK Investigational Site
Almada, 2801-915, Portugal
GSK Investigational Site
Amadora, 2720-276, Portugal
GSK Investigational Site
Coimbra, 3000-075, Portugal
GSK Investigational Site
Lisbon, 1649-035, Portugal
GSK Investigational Site
Porto, 4099-001, Portugal
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 020475, Romania
GSK Investigational Site
Bucharest, 11172, Romania
GSK Investigational Site
Moscow, 115522, Russia
GSK Investigational Site
Saint Petersburg, 190068, Russia
GSK Investigational Site
Yaroslavl, 150030, Russia
GSK Investigational Site
Belgrade, 11000, Serbia
GSK Investigational Site
Belgrade, 11080, Serbia
GSK Investigational Site
Singapore, 529889, Singapore
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 8035, Spain
GSK Investigational Site
Granada, 18012, Spain
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Lund, SE-221 85, Sweden
GSK Investigational Site
Stockholm, SE-171 76, Sweden
GSK Investigational Site
Gueishan Township,Taoyuan County, 333, Taiwan
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Kaohsiung City, 813, Taiwan
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Rajathevee, 10400, Thailand
GSK Investigational Site
Ratchatewi, 10400, Thailand
GSK Investigational Site
Songkhla, 90110, Thailand
GSK Investigational Site
Kharkiv, 61039, Ukraine
GSK Investigational Site
Kyiv, 01601, Ukraine
GSK Investigational Site
Odesa, 65026, Ukraine
GSK Investigational Site
Poltava, 36011, Ukraine
GSK Investigational Site
Vinnytsia, 21018, Ukraine
GSK Investigational Site
Zaporizhzhia, 69600, Ukraine
GSK Investigational Site
Coventry, Warwickshire, CV2 2DX, United Kingdom
GSK Investigational Site
Birmingham, B15 2TH, United Kingdom
GSK Investigational Site
London, SE1 7EH, United Kingdom
Related Publications (10)
Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.
PMID: 39115551DERIVEDJagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.
PMID: 38216728DERIVEDGomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.
PMID: 37228028DERIVEDBrunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
PMID: 34531304DERIVEDHannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVEDMaslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
PMID: 33568389DERIVEDLokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1):e000438. doi: 10.1136/lupus-2020-000438.
PMID: 33558436DERIVEDDoria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.
PMID: 29807477DERIVEDDoria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.
PMID: 29671280DERIVEDStohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.
PMID: 28118533DERIVED
Related Links
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2011
First Posted
December 2, 2011
Study Start
November 16, 2011
Primary Completion
February 13, 2015
Study Completion
October 1, 2015
Last Updated
June 6, 2018
Results First Posted
July 25, 2017
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.