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A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis

This study is currently recruiting participants.
Verified by Hoffmann-La Roche, August 2008

Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00504270
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: R3421
Drug: Placebo
Phase II

MedlinePlus related topics:   Psoriasis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, pharmacokinetics. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in static PGA score, PASI and exploratory biomarkers. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Study Start Date:   July 2007

Arms Assigned Interventions
1: Experimental Drug: R3421
20mg po daily
2: Experimental Drug: R3421
120mg po daily
3: Placebo Comparator Drug: Placebo
po daily

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504270

Contacts
Contact: Please Reference Study ID Number: NS20454     973-235-5000    
Contact: or     800-526-6367 (FOR US ONLY)    

Locations
United States, Arkansas
Recruiting
      Little Rock, Arkansas, United States, 72205
Recruiting
      Hot Springs, Arkansas, United States, 71913
United States, California
Recruiting
      Santa Monica, California, United States, 90404
United States, Georgia
Recruiting
      Alpharetta, Georgia, United States, 30005
United States, New Jersey
Recruiting
      East Windsor, New Jersey, United States, 08520
United States, New Mexico
Recruiting
      Albuquerque, New Mexico, United States, 87106
United States, New York
Recruiting
      New York, New York, United States, 10029
Recruiting
      New York, New York, United States, 10016
Recruiting
      Stony Brook, New York, United States, 11790
United States, North Carolina
Recruiting
      Winston-Salem, North Carolina, United States, 27157
United States, Rhode Island
Recruiting
      Providence, Rhode Island, United States, 02903
United States, Tennessee
Recruiting
      Nashville, Tennessee, United States, 37215
United States, Texas
Recruiting
      San Antonio, Texas, United States, 78229
Recruiting
      Houston, Texas, United States, 77030
Recruiting
      Houston, Texas, United States, 77058

Sponsors and Collaborators
Hoffmann-La Roche

Investigators
Study Director:     Clinical Trials     Hoffmann-La Roche    
  More Information

Responsible Party:   Hoffmann-La Roche ( Clinical Trials )
Study ID Numbers:   NS20454
First Received:   July 18, 2007
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00504270
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 05, 2008




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