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

Hoffmann-La Roche66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

PlaceboDRUG

po daily

RG3421 120mgDRUG

120mg po daily

RG3421 20mgDRUG

20mg po daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (15)

Unnamed facility

Hot Springs, Arkansas, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Santa Monica, California, United States

Outcomes

Primary Outcomes

Adverse events (AEs), laboratory parameters, pharmacokinetics

Time frame: Throughout study

Secondary Outcomes

Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers

Time frame: Throughout study

Data from ClinicalTrials.gov

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