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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/7/2018
Start Date:November 16, 2011
End Date:October 1, 2015

Use our guide to learn which trials are right for you!

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)

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).

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled,
52-week study to evaluate the efficacy, safety and tolerability of belimumab administered
subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus
Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of
about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects
completing the 52-week double-blind period can enter a 6-month open-label extension in which
all subjects receive belimumab 200 mg SC weekly.

Inclusion Criteria:

1. At least 18 years of age.

2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.

3. Active SLE disease.

4. Autoantibody-positive.

5. 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.)

Exclusion Criteria:

1. Pregnant or nursing.

2. Have received treatment with any B cell targeted therapy (for example, rituximab or
belimumab).

3. Have received treatment an investigational biological agent in the past year.

4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.

5. Have severe active lupus kidney disease.

6. Have severe active central nervous system (CNS) lupus.

7. Have required management of acute or chronic infections within the past 60 days.

8. Have current drug or alcohol abuse or dependence.

9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
C.

10. Have a history of hypersensitivity reactions to contrast agents or biological
medicines.
We found this trial at
72
sites
Duncansville, Pennsylvania 16635
244
mi
from 43215
Duncansville, PA
Click here to add this to my saved trials
Allentown, Texas 75013
892
mi
from 43215
Allentown, TX
Click here to add this to my saved trials
Arlington, Virginia 22205
322
mi
from 43215
Arlington, VA
Click here to add this to my saved trials
Atlanta, Georgia 30341
424
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
1064
mi
from 43215
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
982
mi
from 43215
Aventura, FL
Click here to add this to my saved trials
Baltimore, Maryland 21201
343
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
801
mi
from 43215
Baton Rouge, LA
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18105
400
mi
from 43215
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35249
493
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Boca Raton, Florida 33486
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
Boise, Idaho 83712
1714
mi
from 43215
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02115
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
521
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
Brooklyn, New York 11215
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
353
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
524
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
348
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires
5386
mi
from 43215
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43219
7
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Coral Gables, Florida 33134
994
mi
from 43215
Coral Gables, FL
Click here to add this to my saved trials
Cumberland, Maryland 21502
227
mi
from 43215
Cumberland, MD
Click here to add this to my saved trials
Dallas, Texas 75230
905
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45420
60
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
165
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
Duluth, Georgia 30096
416
mi
from 43215
Duluth, GA
Click here to add this to my saved trials
Durham, North Carolina 27705
351
mi
from 43215
Durham, NC
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
966
mi
from 43215
Fort Lauderdale, FL
Click here to add this to my saved trials
Greenville, North Carolina 27858
430
mi
from 43215
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29615
353
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
Hagerstown, Maryland 21742
282
mi
from 43215
Hagerstown, MD
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Jackson, Mississippi 39202
661
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
La Jolla, California 92093
1950
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
Lake Success, New York 10042
492
mi
from 43215
Lake Success, NY
Click here to add this to my saved trials
Las Cruces, New Mexico 88011
1421
mi
from 43215
Las Cruces, NM
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
418
mi
from 43215
Lawrenceville, GA
Click here to add this to my saved trials
Long Beach, California 90813
1976
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
1983
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Manhasset, New York 11030
493
mi
from 43215
Manhasset, NY
Click here to add this to my saved trials
Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
Memphis, Tennessee 38120
501
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33136
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
329
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
Nassau Bay, Texas 77058
992
mi
from 43215
Nassau Bay, TX
Click here to add this to my saved trials
New Orleans, Louisiana 70112
797
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
851
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
463
mi
from 43215
Orangeburg, SC
Click here to add this to my saved trials
Orlando, Florida 32806
797
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Pennsylvania, Wyoming 19610
372
mi
from 43215
Pennsylvania, WY
Click here to add this to my saved trials
Peoria, Arizona 85381
1666
mi
from 43215
Peoria, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
970
mi
from 43215
Plantation, FL
Click here to add this to my saved trials
Saint Clair Shores, Michigan 48081
175
mi
from 43215
Saint Clair Shores, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92111
1948
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
2108
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
San Jose, California 95116
2085
mi
from 43215
San Jose, CA
Click here to add this to my saved trials
San Leandro, California 94578
2093
mi
from 43215
San Leandro, CA
Click here to add this to my saved trials
Seattle, Washington 98109
2007
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Smithtown, New York 11787
519
mi
from 43215
Smithtown, NY
Click here to add this to my saved trials
Springfield, Illinois 62702
349
mi
from 43215
Springfield, IL
Click here to add this to my saved trials
Tampa, Florida 33612
823
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio 43608
121
mi
from 43215
Toledo, OH
Click here to add this to my saved trials
Tucson, Arizona 85724
1639
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74105
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Tustin, California 92780
1957
mi
from 43215
Tustin, CA
Click here to add this to my saved trials
Upland, California 91786
1940
mi
from 43215
Upland, CA
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
373
mi
from 43215
Wyomissing, PA
Click here to add this to my saved trials