Trial information
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Status: Recruiting
Protocol number: NS20454
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 type: Interventional; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
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:
- adult patients, 18-70 years of age;
- medically stable, moderate to severe chronic plaque psoriasis.
Exclusion criteria:
- any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- confounding or concomitant condition or treatment.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Anticipated start date: July, 2007
Trial registration date: 07/18/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Hot Springs, AR
- Little Rock, AR
- Santa Monica, CA
- Alpharetta, GA
- East Windsor, NJ
- Albuquerque, NM
- New York, NY
- Stony Brook, NY
- Winston-Salem, NC
- Providence, RI
- Nashville, TN
- Houston, TX
- San Antonio, TX
