Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Dermatology/Plastic Surgery | Rheumatology
Disease Category: Psoriasis and Psoriatic Disorders
Trial Information
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Status: Not yet recruiting
Protocol Number: NS20454
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: A randomized, placebo-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 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.
Target sample size is
170
.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Psoriasis
Intervention Type: Drug
Intervention Name: R3421
Primary Outcome: 1
.
AEs,laboratory parameters,pharmacokinetics
Time frame:
Throughout study
Key Secondary Outcomes: 1. Change from baseline in static PGA score, PASI and exploratory biomarkers Time frame: 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
Accepts Healthy Volunteers: No
Anticipated Start Date: July, 2007
Trial Registration Date: 07/18/2007
Date Last Updated: 09/16/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Little Rock, AR 72205
Phone: 888-662-6728 (U.S. Only)
View Google Map
DISCLAIMER: 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.
