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

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

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