A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

December 2, 2016 updated by: Human Genome Sciences Inc.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

819

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Innere Medizin
      • Vienna, Austria, 1100
        • Rheumazentrum Favoriten
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires
      • Leuven, Belgium, 3000
        • University Hospital
      • Liege, Belgium, 4000
        • Chu Sart Tilman
  • Canada
      • Montreal, Canada, H3G 1A4
        • McGill University Health Centre, Montreal General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5T2S8
        • Centre for Prognosis Studies in Rheaumatic Diseases
  • Costa Rica
      • San Jose, Costa Rica
        • Hospital Clínica Bíblica
  • Czech Republic
      • Brno, Czech Republic, 62500
        • University Hospital Brno
      • Hradec Kralove, Czech Republic, 50005
        • University hospital Hradec Králové
      • Olomouc, Czech Republic, 77520
        • University Hospital Olomouc
      • Prague, Czech Republic, 12850
        • Institute of Rheumatology
  • France
      • Le Kremlin Bicetre, France, 94270
        • CHU Hospital de Bicetre
      • Lille Cedex, France, 59037
        • Hospital Huriez
      • Stasbourg, France, 67091
        • Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
      • Suresnes Cedex, France, 92151
        • Hospital Foch
      • Toulouse, France, 31059
        • Centre Hospitalier Universitarie (CHU) - PURPAA
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klink Bad Nauheim
      • Berlin, Germany, 13353
        • Charité
      • Berlin, Germany, 10589
        • Schlossparkklinik
      • Dusseldorf, Germany, 40225
        • Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
      • Erlangen, Germany, 91054
        • FA Universitat Erlangen Nurnberg
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Freiburg, Germany, 79106
        • Medizinische Universitätsklinik
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07740
        • Friedrich Schiller Universitat
      • Kiel, Germany, 24105
        • Universitatsklinik Schleswig-Holstein, Campus Kiel
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Mainz, Germany, 55131
        • Universitatsklinik Mainz
      • Tubingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 31048
        • B'nai-Zion Medical Center
      • Petach Tikva, Israel, 49100
        • Beilinson Hospital, Rabin medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Saurasky Medical Center
  • Italy
      • Ferrara, Italy, 44100
        • A. O. Ospedaliera-Universitaria Arcispedale
      • Milano, Italy, 20153
        • A.O. Ospedale San Carlo Borromeo
      • Modena, Italy, 41100
        • Policlinico di Modena
      • Padova, Italy, 35128
        • Policlinico Universitario of Padova
      • Rome, Italy, 00152
        • A.O. San Camillo
      • Rome, Italy, 00161
        • Policlinico Umberto 1
      • Scafati, Italy, 84018
        • U.O. di reumatologia Presidio Ospedaliero di Scafati
      • Udine, Italy, 33100
        • Azienda Ospedaliero University-Santa Maria della Misericordia
  • Mexico
      • Guadalajara, Mexico, 45235
        • Hospital Civil de Guadalajara "Fray Antonio Alcalde"
      • Jalisco, Mexico, 44100
        • Instituto Jalisciense de Investigacion Clinica
      • Mexico City, Mexico, 06726
        • Hospital General de Mexico
      • Mexico City, Mexico, 07760
        • Hospital Regional 1o de Octubre - ISSSTE
      • Mexico City, Mexico, 14000
        • Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
      • San Luis Potosi, Mexico, 78240
        • Hospital Central de S.L.P. "Iganico Morones Prieto"
      • Toluca, Mexico, 52170
        • Instituto de Seguridad Social del Estado de Mexico y Municipios
  • Netherlands
      • Leiden, Netherlands, 2333ZA
        • Leiden University Medical Center
      • Maastricht, Netherlands, 6229HX
        • University Medical Center Maastricht
      • Rotterdam, Netherlands, 3015CE
        • Erasmus Medical Center
      • Rotterdam, Netherlands, 3083AN
        • Ikazia Ziekenhuis
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwerytecki nr Zim. dr. Jana Biziela
      • Konskie, Poland, 26-200
        • Szpital Specjalistyczny Sw. Lukasza
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne
      • Lublin, Poland, 20-022
        • Gabinety Profesorow Osrodek Baden Klinicznych
      • Warszawa, Poland, 02-637
        • Klinika Reumatologii im Prof. Eleonory Reicher
      • Wroclaw, Poland, 50-556
        • Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine
      • Rio Piedras, Puerto Rico, 00935
        • University of Puerto Rico Medical Center
  • Romania
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 011170
        • Spitalul Clinic "Sf Maria"
  • Slovakia
      • Piestany, Slovakia, 92112
        • Narodny ustav reumatickych chorob
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial Barcelona
      • Barcelona, Spain, 08035
        • Hospital La Vall d'Hebron
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de SAS - Carlos Haya
      • Mallorca, Spain, 07014
        • Hospital Son Dureta
  • Sweden
      • Goteborg, Sweden, 41345
        • Sahlgrensja University Hospital
      • Stockholm, Sweden, 17176
        • Karolinska Universitetssjukhuset
  • United Kingdom
      • London, United Kingdom, SE17EH
        • St. Thomas Hospital
      • Newcastle upon Tyne, United Kingdom, NE77DN
        • Freeman Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis and Rheumatology Research, PPLC
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Arthritis Center
    • California
      • Huntington Beach, California, United States, 92646
        • Talbert Medical Group
      • Long Beach, California, United States, 90806
        • Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Wallace Rheumatic Study Center
      • Los Angeles, California, United States, 90095
        • UCLA Rheumatology
      • San Jose, California, United States, 95126
        • Arthritis Care Center, Inc.
      • Upland, California, United States, 91786
        • Inland Rheumatic Disease Specialties
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Arthritis Associates of Colorado Springs
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Miami, Florida, United States, 03136
        • University of Miami-Division of Rheumatology and Immunology
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida
      • Tampa, Florida, United States, 33609
        • Southwest Florida Clinical Research Center
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Idaho
      • Boise, Idaho, United States, 83704
        • Selah Medical Clinical Research Unit
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rheumatology Associates, SC
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
    • Indiana
      • Munster, Indiana, United States, 46321
        • Medical Specialists Clinical Research
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Center for Better Bone and Joint Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
      • Cumberland, Maryland, United States, 21502
        • Osteoporosis and Clinical Trials Center
      • Hagerstown, Maryland, United States, 21740
        • Osteoporosis & Clinical Trials Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TUFTS - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0358
        • University of Michigan Medical Center - Regents of University of Michigan
      • Lansing, Michigan, United States, 48910
        • Fiechtner Research, Inc.
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Stafford Medical Associates, PA
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY-Downstate Medical Center
      • Lake Success, New York, United States, 11042
        • North Shore-LIJ Health System/Rheumatology and Allergy Clinic
      • Manhasset, New York, United States, 11030
        • Feinstein Institute
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10003
        • Hopital for Joint Diseases
      • Rochester, New York, United States, 14618
        • AAIR Research Center
      • Smithtown, New York, United States, 11787
        • Rheumatology Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • University of North Carolina at Chapel Hill
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Services
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Dayton, Ohio, United States, 45408
        • STAT Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 74104
        • Oklahoma Medical Research Center
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Center For Arthritis Therapy & Research
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Associates
      • Duncanville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA/Low Country Research Center
      • Greenville, South Carolina, United States, 29601
        • Palmetto Clinical Trial at Piedmont Arthritis Clinic
    • Texas
      • Austin, Texas, United States, 78705
        • Walter Chase
      • Dallas, Texas, United States, 75390-8884
        • University of Texas - Southwestern Medical Center
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
      • Houston, Texas, United States, 77074
        • Houston Institute for Clinical Research
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research
      • Houston, Texas, United States, 77004
        • The Rheumatic Disease Clinical Research Center
      • San Antonio, Texas, United States, 78232
        • Arthritis Center of South Texas
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Rheumatology Clinic
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.
    • Washington
      • Seattle, Washington, United States, 98133
        • The Seattle Arthritis Clinic
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC
    • Wisconsin
      • Onalaska, Wisconsin, United States, 54650
        • Gundersen Clinic, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
EXPERIMENTAL: Belimumab 1 mg/kg
Drug: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Names:
  • belimumab
  • LymphoStat-B™
EXPERIMENTAL: Belimumab 10 mg/kg
Drug: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Names:
  • belimumab
  • LymphoStat-B™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE Responder Index (SRI) Response Rate at Week 52
Time Frame: Baseline, 52 Weeks

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).
Baseline, 52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRI Response Rate at Week 76
Time Frame: Baseline, 76 Weeks

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).
Baseline, 76 Weeks
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Time Frame: Baseline, 52 Weeks
Baseline, 52 Weeks
Mean Change in Physician's Global Assessment (PGA) at Week 24.
Time Frame: Baseline, 24 Weeks
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.
Baseline, 24 Weeks
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.
Time Frame: Baseline, 24 Weeks
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.
Baseline, 24 Weeks
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
Time Frame: Baseline, Weeks 40-52
Baseline, Weeks 40-52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event (AE) Overview
Time Frame: Up to 80 Weeks
SEE ALSO ADVERSE EVENT RESULTS SECTION
Up to 80 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Genome Sciences Inc.

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (ESTIMATE)

December 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGS1006-C1056
  • BLISS-76
  • 110751 (OTHER: GSK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: HGS1006-C1056
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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