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

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ClinicalTrials.gov Identifier: NCT02443506
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: AMG 623 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: AMG 623
Single dose of AMG 623 administered as subcutaneous and intravenous doses
Drug: AMG 623
Single dose of AMG 623 administered as subcutaneous and intravenous doses

Placebo Comparator: Placebo
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses
Drug: Placebo
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses




Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [ Time Frame: up to 70 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443506


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02443506     History of Changes
Other Study ID Numbers: 20040147
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases