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| Descriptive Information Fields | |||||||||
| Brief Title † | A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis | ||||||||
| Official Title † | 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 | ||||||||
| Brief Summary | This 3 arm 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | AEs, laboratory parameters, pharmacokinetics. [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Change from baseline in static PGA score, PASI and exploratory biomarkers. [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Psoriasis | ||||||||
| Intervention † | Drug: R3421 Drug: Placebo |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | |||||||||
| Start Date † | July 2007 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00504270 | ||||||||
| Organization ID | NS20454 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hoffmann-La Roche | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Hoffmann-La Roche | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | July 18, 2007 | ||||||||
| Last Updated Date | August 14, 2008 | ||||||||
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