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Study Complete
Sponsor ID
20060203

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects with Systemic Lupus Erythematosus

Sponsor ID
20060203
Clinicaltrials.gov ID
NCT02291588
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

Additional Study Details

Phase
Phase 1
Product
AMG 811
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
26
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs

Timeframe: between 84 and 196 days

Secondary Outcome Measures

Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax

Timeframe: between 84 and 196 days

Study Documents

Study Synopsis
Available Language(s): English
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Locations

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Study Info
Age
N/A
Condition
  • Lupus
    • Sex
    N/A
    Trial Dates
    Dec 2007 - Mar 2010
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before randomization
    Exclusion Criteria:
    - Subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 BILAG ‘A’ score or 2 BILAG ‘B’ scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year