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 |
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).
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
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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1601 Northwest 12th Avenue
Miami, Florida 33136
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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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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