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| Tracking Information | |||||||||
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| First Received Date † | July 18, 2007 | ||||||||
| Last Updated Date | April 15, 2009 | ||||||||
| Start Date † | July 2007 | ||||||||
| Current Primary Outcome Measures † |
AEs,laboratory parameters,pharmacokinetics [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00504270 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Change from baseline in static PGA score, PASI and exploratory biomarkers [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| 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 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), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Psoriasis | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 150 | ||||||||
| Estimated Completion Date | August 2008 | ||||||||
| Primary 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 | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00504270 | ||||||||
| Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hoffmann-La Roche | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Hoffmann-La Roche | ||||||||
| Verification Date | April 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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