Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/3/2018
Start Date:December 2013
End Date:September 2016

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A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of
atacicept in subjects with systemic lupus erythematosus (SLE).


Inclusion Criteria:

- Eligible male and female subjects, aged 18 years or older

- Must have at least moderately active SLE, as defined as SLE Disease Activity
Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit

- At least 4 of the 11 American college of rheumatology (ACR) classification criteria
for SLE (diagnosed >= 6 months prior to the screening visit)

- Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded
deoxyribonucleic acid (anti-dsDNA) antibodies

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Subjects have demyelinating disorder

- Severe central nervous system SLE

- Use of cyclophosphamide within 3 months of the screening visit

- Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day

- Other protocol defined exclusion criteria could apply
We found this trial at
31
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Anniston, Alabama 36207
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Birmingham, Alabama 35294
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Charleston, South Carolina 29425
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Charlotte, North Carolina 00000
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Ciudad Autonoma Buenos aires,
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Ciudad Autonoma Buenos aires,
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Cleveland, Ohio 44109
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Columbus, OH
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Danville, Virginia 24541
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Dayton, Ohio 45417
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Dunedin, FL
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Fort Lauderdale, Florida 33334
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Galveston, Texas 77555
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Galveston, TX
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Grand Blanc, Michigan 48439
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Los Angeles, California 90048
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Manhasset, NY
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Newark, New Jersey 07103
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Newark, NJ
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, Oklahoma 73104
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Leandro, California 94578
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tupelo, Mississippi 38801
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Tupelo, MS
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Waco, TX
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Wyomissing, Pennsylvania 19610
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