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NCT Number: NCT02411136

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

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 duration of 31 weeks.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 623

Drug

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Placebo

Drug

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: up to 31 weeks

  2. Incidence of abnormal clinically significant vital signs

    Time frame: up to 31 weeks

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

    Time frame: up to 31 weeks

  4. Incidence of abnormal clinically significant ECG results

    Time frame: up to 31 weeks

Secondary outcomes

  1. Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

    Time frame: up to 31 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 8, 2015
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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