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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411136
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
 Drug: AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Placebo Comparator: Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
 Drug: Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [ Time Frame: up to 31 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02411136


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02411136    
Other Study ID Numbers: 20040250
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases