A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Phase 2
Completed
- Conditions
- Psoriasis
- Interventions
- Drug: PlaceboDrug: RG3421 120mgDrug: RG3421 20mg
- Registration Number
- NCT00504270
- Lead Sponsor
- Hoffmann-La Roche
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo po daily RG3421 120mg RG3421 120mg 120mg po daily RG3421 20mg RG3421 20mg 20mg po daily
- Primary Outcome Measures
Name Time Method Adverse events (AEs), laboratory parameters, pharmacokinetics Throughout study
- Secondary Outcome Measures
Name Time Method Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers Throughout study