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

NCT ID: NCT00504270

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

po daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po daily

RG3421 120mg

120mg po daily

Group Type EXPERIMENTAL

RG3421 120mg

Intervention Type DRUG

120mg po daily

RG3421 20mg

20mg po daily

Group Type EXPERIMENTAL

RG3421 20mg

Intervention Type DRUG

20mg po daily

Interventions

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Placebo

po daily

Intervention Type DRUG

RG3421 120mg

120mg po daily

Intervention Type DRUG

RG3421 20mg

20mg po daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Hot Springs, Arkansas, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Santa Monica, California, United States

Site Status

Alpharetta, Georgia, United States

Site Status

East Windsor, New Jersey, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Stony Brook, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Providence, Rhode Island, United States

Site Status

Nashville, Tennessee, United States

Site Status

Galveston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Webster, Texas, United States

Site Status

Countries

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Canada United States

Other Identifiers

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NS20454

Identifier Type: -

Identifier Source: org_study_id