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| Descriptive Information Fields | |||||
| Brief Title † | AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects | ||||
| Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 714 After Multiple Dose Administration in Subjects With Moderate to Severe Psoriasis | ||||
| Brief Summary | Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Psoriatic Assessment Score Index [ Time Frame: First 85 Days ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Safety and Tolerability [ Time Frame: Collected for 300 Days ] [ Designated as safety issue: No ] | ||||
| Condition † | Psoriasis | ||||
| Intervention † | Drug: AMG 714 | ||||
| MEDLINE PMIDs | |||||
| Links | AmgenTrials clinical trials website ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 66 | ||||
| Start Date † | March 2007 | ||||
| Completion Date | April 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00443326 | ||||
| Organization ID | 20060349 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Amgen | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Amgen | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | March 1, 2007 | ||||
| Last Updated Date | September 18, 2008 | ||||