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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00192517 |
The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
Condition | Intervention | Phase |
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Psoriasis |
Drug: MEDI-522 Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of MEDI-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis |
Enrollment: | 44 |
Study Start Date: | December 2003 |
Study Completion Date: | September 2004 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
MEDI-522
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Drug: MEDI-522
4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
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2: Placebo Comparator
Placebo
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Other: Placebo
4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Barbara White, M.D. | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( Barbara White, M.D. ) |
Study ID Numbers: | MI-CP102 |
Study First Received: | September 13, 2005 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00192517 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Skin Diseases |
Psoriasis Skin Diseases, Papulosquamous Immunoglobulins |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |