Back to resultsA Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 623
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 623
Placebo
Arm Description
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events
Incidence of abnormal clinically significant vital signs
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Incidence of abnormal clinically significant ECG results
Secondary Outcome Measures
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02411136
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 623
Arm Type
Experimental
Arm Description
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Intervention Type
Drug
Intervention Name(s)
AMG 623
Intervention Description
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Time Frame
up to 31 weeks
Title
Incidence of abnormal clinically significant vital signs
Time Frame
up to 31 weeks
Title
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time Frame
up to 31 weeks
Title
Incidence of abnormal clinically significant ECG results
Time Frame
up to 31 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
Time Frame
up to 31 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26290435
Citation
Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
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