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Trial Information
Summary:A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis. Status: Recruiting Protocol Number: NS20454 Sponsor: Company Division: Pharmaceutical Official Scientific Title: A randomized, pleacebo-controlled dose-ranging pilot study to assess the effect on clinical response, and the safety and tolerability of R3421 in patients with moderate to severe chronic plaque psoriasis. Brief Summary: This 3 arm study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Study Phase: II Study Design / Study Details:
Study Type: Interventional
Condition: Psoriasis Intervention Type: Drug Intervention Name: R3421 Primary Outcome: AEs, laboratory parameters, pharmacokinetics. Timeframe: Throughout study. Key Secondary Outcomes: Change from baseline over time in static PGA score, PASI and exploratory biomarkers. Timeframe: Throughout study. Inclusion Criteria:
Exclusion Criteria:
Gender: Males or Females Age Limits: Min: 18 Years Max: 70 Years Accepts Healthy Volunteers: No Anticipated Start Date: July, 2007 Trial Registration Date: 07/18/2007 Date Last Updated: 04/16/2008
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