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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00424476




Registration number
NCT00424476
Ethics application status
Date submitted
17/01/2007
Date registered
19/01/2007
Date last updated
12/12/2016

Titles & IDs
Public title
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
Scientific title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 0 0
BLISS-52
Secondary ID [2] 0 0
HGS1006-C1057
Universal Trial Number (UTN)
Trial acronym
BLISS-52
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Belimumab 1 mg/kg
Treatment: Drugs - Belimumab 10 mg/kg

Placebo comparator: Placebo - Placebo

Experimental: Belimumab 1 mg/kg - Belimumab 1 mg/kg

Experimental: Belimumab 10 mg/kg - Belimumab 10 mg/kg


Treatment: Drugs: Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Treatment: Drugs: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Treatment: Drugs: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SLE Responder Index (SRI) Response Rate at Week 52
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [1] 0 0
Percent of Subjects With a = 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [2] 0 0
Mean Change in Physician's Global Assessment (PGA) at Wk 24.
Timepoint [2] 0 0
Baseline, 24 weeks
Secondary outcome [3] 0 0
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.
Timepoint [3] 0 0
Baseline, 24 weeks
Secondary outcome [4] 0 0
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by = 25% From Baseline to = 7.5 mg/Day During Weeks 40 Through 52
Timepoint [4] 0 0
Baseline, Weeks 40 through 52

Eligibility
Key inclusion criteria
Key

* Clinical diagnosis of SLE by ACR criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or nursing
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have 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 historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
865
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Repatriation Hospital - Daw Park
Recruitment hospital [2] 0 0
Emeritus Research, Cabrini Hospital - Melbourne
Recruitment hospital [3] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Shenton Park
Recruitment postcode(s) [1] 0 0
5041 - Daw Park
Recruitment postcode(s) [2] 0 0
3144 - Melbourne
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment postcode(s) [4] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
La Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
Rosario
Country [5] 0 0
Argentina
State/province [5] 0 0
San Miguel de Tucuman
Country [6] 0 0
Brazil
State/province [6] 0 0
Campinas
Country [7] 0 0
Brazil
State/province [7] 0 0
Curitiba
Country [8] 0 0
Brazil
State/province [8] 0 0
Fortaleza
Country [9] 0 0
Brazil
State/province [9] 0 0
Goiânia
Country [10] 0 0
Brazil
State/province [10] 0 0
Juiz de Fora
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
Salvador
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Chile
State/province [16] 0 0
Viña del Mar
Country [17] 0 0
Colombia
State/province [17] 0 0
Cundinamarca
Country [18] 0 0
Colombia
State/province [18] 0 0
Santander
Country [19] 0 0
Colombia
State/province [19] 0 0
Barranquilla
Country [20] 0 0
Colombia
State/province [20] 0 0
Bogota
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogotá
Country [22] 0 0
Colombia
State/province [22] 0 0
Bucaramanga
Country [23] 0 0
Colombia
State/province [23] 0 0
Medellín
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Chai Wan
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Shatin
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Tuen Mun
Country [27] 0 0
India
State/province [27] 0 0
Bangalore
Country [28] 0 0
India
State/province [28] 0 0
Hyderabaad
Country [29] 0 0
India
State/province [29] 0 0
Hyderabad
Country [30] 0 0
India
State/province [30] 0 0
Lucknow
Country [31] 0 0
India
State/province [31] 0 0
Mumbai
Country [32] 0 0
India
State/province [32] 0 0
Trivandrum
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Daejeon
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Inchon
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Pusan
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Suwon
Country [39] 0 0
Peru
State/province [39] 0 0
Lima
Country [40] 0 0
Philippines
State/province [40] 0 0
Cebu City
Country [41] 0 0
Philippines
State/province [41] 0 0
Davao City
Country [42] 0 0
Philippines
State/province [42] 0 0
Las Pinas City
Country [43] 0 0
Philippines
State/province [43] 0 0
Manila City
Country [44] 0 0
Philippines
State/province [44] 0 0
Quezon City
Country [45] 0 0
Romania
State/province [45] 0 0
Bucharest
Country [46] 0 0
Romania
State/province [46] 0 0
Cluj Napoca
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Moscow
Country [48] 0 0
Russian Federation
State/province [48] 0 0
St. Petersburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
St.-Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Yaroslavl
Country [51] 0 0
Taiwan
State/province [51] 0 0
Chia-Yi
Country [52] 0 0
Taiwan
State/province [52] 0 0
Haulien
Country [53] 0 0
Taiwan
State/province [53] 0 0
Kaohsiung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Kaosiung
Country [55] 0 0
Taiwan
State/province [55] 0 0
Keelung
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei
Country [58] 0 0
Taiwan
State/province [58] 0 0
Tau-Yuan County

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Human Genome Sciences Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Trial website
https://clinicaltrials.gov/study/NCT00424476
Trial related presentations / publications
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Brunner 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.
Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.
Maslen 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.
Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.
van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.
Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.
Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.
van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.
Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.
Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, Leon MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
Human Genome Sciences Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00424476