A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT02391259
Last Updated: 2015-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2006-11-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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AMG 557
AMG 557 administered as subcutaneous and intravenous doses.
AMG 557
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
Placebo
No active drug
Placebo
contains no active drug
Interventions
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AMG 557
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
Placebo
contains no active drug
Eligibility Criteria
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Inclusion Criteria
* Stable disease with no change in SLE therapy within the previous 30 days
* BMI from 18 to 38 kg/m2
Exclusion Criteria
* Evidence of renal disease or liver disease
* Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
* Prior administration of any other biologic that primarily targets the immune system
18 Years
70 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anniston, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Michigan City, Indiana, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
Manhasset, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
London, , United Kingdom
Countries
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References
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Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016.
Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060132
Identifier Type: -
Identifier Source: org_study_id
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