Conditions: Plaque Psoriasis
Keywords: Single dose psoriasis study
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not the body will develop an immune reaction (sensitivity) to the drug.

Detailed description:
B1991002 study is a phase 1 adaptive design study which terminated on 14Mar2011. Regular analyzes of psoriasis assessments conducted per the statistical plan indicate that even if every patient enrolled for the rest of the study respond (up to 23 additional subjects), the study can not meet its primary efficacy endpoint. Pfizer Inc. has terminated the trial and clinical team is asking all clinical investigators to continue collecting safety, pharmacokinetics and pharmacodynamics data until the last subject last visit for all subjects who received test article. Last Subject Last Visit occurred 20May2011.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ILV-095 300 mg in a 4 to 1 ratio intervention 2: ILV-095 300 mg in a 4 to 1 ratio
Intervention descriptions: intervention 1: Single dose of ILV-095 300 mg intervention 2: Single dose of Placebo

Protocol document: