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Systemic Lupus ErythematosusPhase 3BLISS-52NCT00424476

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 3 study testing Belimumab 1 mg/kg and Belimumab 10 mg/kg in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 92 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Belimumab 1 mg/kg and Belimumab 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
865 participants
Where
92 sitesin 13 countries
Study dates
May 2007to Mar 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

92 sites in 13 countries.

92 sites in 13 countries

Brazil12 sites

  • Hospital de Clínicas - UNICAMP

    Campinas, 13083-888

  • Hospital das Clínicas - Universidade do Paraná

    Curitiba, 80060-240

  • Hospital de Clínicas - Universidade Federal de Pernambuco

    Fortaleza, 50670-901

  • Hospital Geral de Goiânia

    Goiânia, 74110-120

  • Hospital Universitário - Universidade Federal de Juiz de Fora

    Juiz de Fora, 36010-570

  • Hospital São Lucas da PUC-RS

    Porto Alegre, 90610-000

  • Hospital Universitário Pedro Ernesto - UERJ

    Rio de Janeiro, 20551-030

  • Hospital Unversitario Clementino Fraga Filho UFRJ

    Rio de Janeiro, 21941-913

  • Hospital Santa Izabel

    Salvador, 40050-410

  • Hospital Abreu Sodré

    São Paulo, 04027-000

  • Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira

    São Paulo, 04039-901

  • Hospital Heliópolis

    São Paulo, 04266-010

Other trials in Brazil

Argentina11 sites

  • OMI, Organización Médica de Investigación

    Buenos Aires, C1015ABO

  • CIER, Centro de Investigaciones en Enfermedades Reumáticas

    Buenos Aires, C1055AAF

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Hospital General de Agudos Carlos G. Durand

    Buenos Aires, C1405DCS

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

  • Hospital Sirio Libanes

    Buenos Aires, C1419AHN

  • Atencion Integral en Reumatologia

    Buenos Aires, C1426AAL

  • Instituto de Investigaciones Medicas

    Buenos Aires, C1427ARO

  • Hospital Interzonal General San Martín

    La Plata, B1904CFH

  • CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral

    Rosario, S2000PBJ

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Taiwan11 sites

  • Buddhist Tzu Chi General Hospital, Dalin

    Chiayi City, 622

  • Buddhist Tzu Chi General Hospital - Hualien

    Haulien, 970

  • Chung-Ho Memorial Hospital, Kaohsiung Medical University

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Chang Gung Memorial Hospital, Kaosiung

    Kaosiung, 833

  • Chang Gung Memorial Hospital-Keelung

    Keelung, 204

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital, Linko

    Tau-Yuan County, 333

Other trials in Taiwan

South Korea10 sites

  • Kyungpook National Univesity Hospital

    Daegu, 700-721

  • Eulji University Hospital

    Daejeon, 302-799

  • Inha University Hospital

    Inchon, 400-711

  • Dong-A University Hospital 3-1 (Dept. Rhuematology)

    Pusan, 602-715

  • Pusan National University Hospital

    Pusan, 602-739

  • Seoul National University Hospital

    Seoul, 110-744

  • The Hospital for Rheumatic Diseases, Hanyang University Hospital

    Seoul, 133-792

  • Catholic Universtigy of Korea, Kangnam St. Mary's Hospital

    Seoul, 137-701

  • Catholic University, Yoido St. Mary's Hospital

    Seoul, 150-713

  • Ajou University Hospital

    Suwon, 443-721

Other trials in South Korea

Colombia9 sites

  • Centro de Reumatologia y Ortopedia

    Barranquilla

  • Office of Dr. Guzman

    Bogota, Cundinamarca

  • Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)

    Bogotá

  • Fundación Instituto de Reumatología Fernando Chalem

    Bogotá

  • Riesgo de Fracturas

    Bogotá

  • Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle

    Bucaramanga, Santander Department

  • SERVIMED

    Bucaramanga

  • Corporación para Investigaciones Biológicas (CIB)

    Medellín

  • Office of Dr. Jose Molina

    Medellín

Other trials in Colombia

India7 sites

  • St. John's Medical College Hospital

    Bangalore, 560 034

  • Krishna Institute of Medical Sciences

    Hyderabaad, 500 003

  • Nizam's Institute of Medical Sciences

    Hyderabaad, 500 082

  • Apollo Hospitals

    Hyderabad, 500 033

  • Chhatrapati Shahuji Maharaj Medical University

    Lucknow, 226018

  • King Edward Memorial (K.E.M.) Hospital

    Mumbai, 400 012

  • Kerala Institute of Medical Sciences

    Trivandrum, 695029

Other trials in India

Philippines6 sites

  • Chong Hua Hospital

    Cebu City, 6000

  • Davao Medical Center

    Davao City, 8000

  • University of Perpetual Help -Rizal

    Las Piñas, 1740

  • Philippine General Hospital

    Manila, 1000

  • University of Santo Tomas Hospital

    Manila, 1008

  • St. Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

Russia6 sites

  • State Institution Scientific Research Institute of Rheumatology

    Moscow, 115522

  • St. Petersburg City Hospital (Rheumatology Center)

    Saint Petersburg, 190068

  • Academy of Post-Graduated Education

    Saint Petersburg, 191015

  • St.-Petersburg Region Clinical Hospital

    Saint Petersburg, 194291

  • Soloviev's City Clinical Hospital,

    Yaroslavl, 150003

  • City Healthcare Institution Municipal Hospital NPZ,

    Yaroslavl, 190068

Other trials in Russia

Romania5 sites

  • Spitalul Clinic Sf Maria

    Bucharest, 011170

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota

    Bucharest, 020125

  • Spitalul Clinic Dr. Ion Cantacuzino

    Bucharest, 020475

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 40006

Other trials in Romania

Australia4 sites

  • Repatriation Hospital

    Daw Park, 5041

  • Emeritus Research, Cabrini Hospital

    Melbourne, 3144

  • Monash Medical Centre

    Melbourne, 3168

  • Royal Perth Hospital

    Shenton Park, 6008

Other trials in Australia

Chile4 sites

  • Hospital Dr. Sotero del Rio

    Santiago, 8207257

  • Pontificia Universidad Católica de Chile

    Santiago, 8330033

  • Clínica Dávila

    Santiago, 8431657

  • Hospital Dr. Gustavo Fricke

    Viña del Mar, 2570017

Other trials in Chile

Peru4 sites

  • Hospital Nacional Alberto Sabogal Sologuren ESSALUD

    Lima, Callao 2

  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

    Lima, L 13

  • Clinica Ricardo Palma Anexo 9 - Javier Prado Este

    Lima, L 27

  • Instituto de Ginecología y Reproducción

    Lima, L 33

Other trials in Peru

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

  • Rheumatology Assessment and Treatment Center, Pok Oi Hospital

    Shatin

  • Tuen Mun Hospital

    Tuenmen

Other trials in Hong Kong

About this study

Official 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)

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.

Being tested
Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
Keywords
Autoimmune Diseases, Lupus, SLE, Systemic Lupus Erythematosus, Belimumab, Antibodies
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • Belimumab 1 mg/kgDrug

    Also called BENLYSTA™ (formerly LymphoStat-B™)

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

  • Belimumab 10 mg/kgDrug

    Also called BENLYSTA™ (formerly LymphoStat-B™)

    Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Study groups in NCT00424476
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Belimumab 1 mg/kgExperimentalBelimumab 1 mg/kg
Receives: Drug: Belimumab 1 mg/kg
Belimumab 10 mg/kgExperimentalBelimumab 10 mg/kg
Receives: Drug: Belimumab 10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SLE Responder Index (SRI) Response Rate at Week 52

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

    Measured: Baseline, 52 weeks

Secondary outcomes (4)

  1. Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.

    Measured: Baseline, 52 weeks

  2. Mean Change in Physician's Global Assessment (PGA) at Wk 24.

    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

    Measured: Baseline, 24 weeks

  3. Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.

    The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

    Measured: Baseline, 24 weeks

  4. Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52

    Measured: Baseline, Weeks 40 through 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
865 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424476
Sponsor's protocol ID
HGS1006-C1057
Other IDs
BLISS-52, 110752
Acronym
BLISS-52
Status last verified
Oct 2016
First submitted
17 Jan 2007
Last updated
12 Dec 2016
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Botto J, Cetrez N, Nikolopoulos D, Regardt M, Heintz E, Lindblom J, Parodis I. Predicting EQ-5D full health state in systemic lupus erythematosus using machine learning algorithms. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkaf032. doi: 10.1093/rap/rkaf032. eCollection 2025.

    PubMed 40256631

  • Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024 Nov;6(11):e751-e761. doi: 10.1016/S2665-9913(24)00162-0. Epub 2024 Aug 26.

    PubMed 39208825

  • 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.

    PubMed 39115551

  • Rendas-Baum R, Chen WH, Gairy K, Anderson S, Henning C, Hammer A, Kosinski M. SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus. Lupus Sci Med. 2024 May 8;11(1):e001118. doi: 10.1136/lupus-2023-001118.

    PubMed 38724182

  • Jesus D, Henriques C, Matos A, Doria A, Ines LS. Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life. Arthritis Care Res (Hoboken). 2024 Jun;76(6):788-795. doi: 10.1002/acr.25305. Epub 2024 Feb 29.

    PubMed 38258369

  • Jagerback 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.

    PubMed 38216728

  • Emamikia S, Oon S, Gomez A, Lindblom J, Borg A, Enman Y, Morand E, Grannas D, van Vollenhoven RF, Nikpour M, Parodis I. Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 Nov 28;61(12):4752-4762. doi: 10.1093/rheumatology/keac185.

    PubMed 35302581

  • 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.

    PubMed 34741731

  • 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.

    PubMed 34628605

  • 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.

    PubMed 34531304

  • 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.

    PubMed 33830377

  • 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.

    PubMed 33568389

  • 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.

    PubMed 32918459

  • 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.

    PubMed 31302695

  • 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.

    PubMed 25396065

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belimumab 1 mg/kg and Belimumab 10 mg/kg in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 92 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in Brazil, Argentina, Taiwan, South Korea, Colombia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SLE Responder Index (SRI) Response Rate at Week 52 (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424476, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.

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