A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis. - Full Text View

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

Purpose

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.

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

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:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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 ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
1: Experimental	Drug: RG3421 20mg po daily
2: Experimental	Drug: RG3421 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

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

Houston, Texas, United States, 77058

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NS20454
Study First Received:	July 18, 2007
Last Updated:	February 26, 2010
ClinicalTrials.gov Identifier:	NCT00504270 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on March 18, 2010