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Completed

NCT Number: NCT02443506

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose 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. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

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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–55 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 55
  • Diagnosis of SLE
  • Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion criteria

  • Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
  • Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
  • Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
  • Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Treatment and study plan

AMG 623

Drug

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Placebo

Drug

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: up to 70 days

  2. Incidence of abnormal clinically significant vital signs

    Time frame: up to 70 days

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

    Time frame: up to 70 days

  4. Incidence of abnormal clinically significant ECG results

    Time frame: up to 70 days

Secondary outcomes

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

    Time frame: up to 70 days

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 14, 2015
Registry last updated
May 14, 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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