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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02411136
First Posted: April 8, 2015
Last Update Posted: April 8, 2015
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.
Information provided by (Responsible Party):
Amgen
  Purpose
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 Intervention Phase
Systemic Lupus Erythematosus Drug: AMG 623 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: up to 31 weeks ]
  • Incidence of abnormal clinically significant vital signs [ Time Frame: up to 31 weeks ]
  • Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results [ Time Frame: up to 31 weeks ]
  • Incidence of abnormal clinically significant ECG results [ Time Frame: up to 31 weeks ]

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

Enrollment: 64
Study Start Date: May 2005
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02411136     History of Changes
Other Study ID Numbers: 20040250
First Submitted: April 3, 2015
First Posted: April 8, 2015
Last Update Posted: April 8, 2015
Last Verified: April 2015

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