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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00443326 |
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.
Condition | Intervention | Phase |
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Psoriasis |
Drug: AMG 714 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 66 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 714: Experimental
AMG 714 will be given as a multiple dose regimen
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Drug: AMG 714
Dosing Regimen is 6 Doses over 3 Months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060349 |
Study First Received: | March 1, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00443326 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee; Canada: Health Canada |
Psoriasis PASI Skin Biopsy Human Monoclonal Antibody |
Antibodies, Monoclonal Antibodies Skin Diseases |
Psoriasis Skin Diseases, Papulosquamous Immunoglobulins |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |