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:

• Purpose:
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: May 5, 2008 at 3:51:57 PM