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History of Changes for Study: NCT02411136
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
Latest version (submitted April 7, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 7, 2015 None (earliest Version on record)
Comparison Format:

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Study NCT02411136
Submitted Date:  April 7, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20040250
Brief Title: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Completed
Study Start: May 2005
Primary Completion: August 2007 [Actual]
Study Completion: October 2007 [Actual]
First Submitted: April 3, 2015
First Submitted that
Met QC Criteria:
April 7, 2015
First Posted: April 8, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 7, 2015
Last Update Posted: April 8, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Amgen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 64 [Actual]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: MD
Study Director
Amgen
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: AmgenTrials clinical trials website
Available IPD/Information:

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