Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
- The primary objective of this study is to compare disease activity, as measured by PASI score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by intravenous infusion every 2 weeks for a total of 8 infusions.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized, Double-Blind, Placebo-Controlled Study of MEDI-507, a Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Intravenous Infusion to Adults With Plaque Psoriasis|
- Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
- Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.
|Study Start Date:||March 2001|
|Estimated Study Completion Date:||December 2001|
|United States, Arizona|
|MDS Pharma Services (US) Inc.|
|Phoenix, Arizona, United States, 85044|
|United States, North Carolina|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Washington|
|Tacoma, Washington, United States, 98403|
|Study Director:||Stanley Pillemer, MD||MedImmune LLC|