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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00504270
First received: July 18, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This study will investigate the safety, efficacy and pharmacokinetics of R3421 i n patients with moderate to severe chronic plaque psoriasis. Patients will be ra ndomized 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 treatme nt is <3 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Psoriasis
Drug: Placebo
Drug: RG3421
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 66
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG3421
20mg po daily
Experimental: 2 Drug: RG3421
120mg po daily
Placebo Comparator: 3 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
Little Rock, Arkansas, United States, 72205
United States, California
Santa Monica, California, United States, 90404
United States, Georgia
Alpharetta, Georgia, United States, 30005
United States, New Jersey
East Windsor, New Jersey, United States, 08520
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
New York, New York, United States, 10029
New York, New York, United States, 10016
Stony Brook, New York, United States, 11790
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, Tennessee
Nashville, Tennessee, United States, 37215
United States, Texas
Galveston, Texas, United States, 77550
San Antonio, Texas, United States, 78229
Webster, Texas, United States, 77598
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00504270     History of Changes
Other Study ID Numbers: NS20454
Study First Received: July 18, 2007
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014