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Study Complete
Sponsor ID
20040250

A study to examine the safety, pharmacokinetics and pharmacodynamics of AMG 623 in subjects with systemic lupus erythematosus

Sponsor ID
20040250
Clinicaltrials.gov ID
NCT02411136
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duratio of 31 weeks.

Additional Study Details

Phase
Phase 1
Product
AMG 623
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
64
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment emergent adverse events

Timeframe: up to 31 weeks

Incidence of abnormal clinically significant vitl signs

Timeframe: up to 31 weeks

Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

Timeframe: up to 31 weeks

Incidence of abnormal clinically significant ECG results

Timeframe: up to 31 weeks

Secondary Outcome Measures

Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

Timeframe: up to 31 weeks

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
N/A
Condition
  • Lupus
    • Sex
    N/A
    Trial Dates
    May 2005 - Aug 2007
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Men and women between the ages of 18 and 65 years old - Diagnosis of SLE - Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization - SLE disease duration of at least 1 year, as diagnosed by a physician
    Exclusion Criteria:
    - Current renal disease - Signs or symptoms of viral or bacterial infection within 30 days of enrollment - Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion - Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization