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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504270

Enrollment

Registered

2007-07-19

Start date

2007-07-31

Completion date

2009-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGPlacebo

po daily

DRUGRG3421 120mg

120mg po daily

DRUGRG3421 20mg

20mg po daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026