Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis
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ClinicalTrials.gov Identifier: NCT01493518 |
Recruitment Status
:
Terminated
(Sponsor decision)
First Posted
: December 16, 2011
Last Update Posted
: November 19, 2013
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
Tracking Information | ||||
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First Submitted Date ICMJE | August 18, 2011 | |||
First Posted Date ICMJE | December 16, 2011 | |||
Last Update Posted Date | November 19, 2013 | |||
Study Start Date ICMJE | November 2011 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 557 [ Time Frame: 28 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01493518 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Subjects With Moderate to Severe Psoriasis | |||
Brief Summary | The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Psoriasis | |||
Intervention ICMJE | Drug: AMG 557 or PLACEBO
Multiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
6 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date | June 2013 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01493518 | |||
Other Study ID Numbers ICMJE | 20110105 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |