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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: RG3421 120mg; Drug: RG3421 20mg

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
    • Little Rock, Arkansas, United States, 72205
  • California
    • Santa Monica, California, United States, 90404
  • Georgia
    • Alpharetta, Georgia, United States, 30005
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • New York, New York, United States, 10016
    • New York, New York, United States, 10029
    • Stony Brook, New York, United States, 11790
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
  • Tennessee
    • Nashville, Tennessee, United States, 37215
  • Texas
    • Galveston, Texas, United States, 77550
    • San Antonio, Texas, United States, 78229
    • Webster, Texas, United States, 77598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; po daily	Drug: Placebo; po daily
Experimental: RG3421 120mg; 120mg po daily	Drug: RG3421 120mg; 120mg po daily
Experimental: RG3421 20mg; 20mg po daily	Drug: RG3421 20mg; 20mg po daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs), laboratory parameters, pharmacokinetics	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 18, 2007
• First Submitted That Met QC Criteria: July 18, 2007
• First Posted (Estimate): July 19, 2007

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: NS20454