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

Tracking Information

First Received Date ^ICMJE

July 18, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

AEs,laboratory parameters,pharmacokinetics [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

AEs, laboratory parameters, pharmacokinetics.

Change History

Complete list of historical versions of study NCT00504270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change from baseline over time in static PGA score, PASI and exploratory biomarkers.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: R3421
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00504270

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

NS20454

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP