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Study Complete
Sponsor ID
20060132

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects with Systemic Lupus Erythematosus

Sponsor ID
20060132
Clinicaltrials.gov ID
NCT02391259
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Additional Study Details

Phase
Phase 1
Product
AMG 557
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
57
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety and tolerability

Timeframe: From 29 days to 169 days

Secondary Outcome Measures

Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax

Timeframe: From 29 days to 169 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Dallas, TX, United States, 75247
Status
Completed
Location
Research Site
London, United Kingdom, NW10 7NS
Status
Completed
Location
Research Site
Los Angeles, CA, United States, 90033
Status
Completed
Location
Research Site
Manhasset, NY, United States, 11030
Status
Completed
Location
Research Site
New York, NY, United States, 10003
Status
Completed
Location
Research Site
North Dartmouth, MA, United States, 02747
Status
Completed
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Study Info
Age
18 - 70 Years
Condition
  • Lupus
    • Sex
    All
    Trial Dates
    Nov 2006 - Sep 2011
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of SLE with positive ANA - Stable disease with no change in SLE therapy within the previous 30 days - BMI from 18 to 38 kg/m2
    Exclusion Criteria:
    - Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization - 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