A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Exploratory Study of the Safety and Efficacy of Oral R115866 vs. R115866 Placebo in the Treatment of Plaque Psoriasis - Oral R115866 psoriasis dose ranging study
- Conditions
- Treatment of Plaque Psoriasis
- Registration Number
- EUCTR2005-004623-19-NL
- Lead Sponsor
- Barrier Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
Subject has completed an appropriately administered informed consent
Subject is at least 18 years old
Subject is a male or is a women who is NOT of childbearing potential
Subject has plaque psoriasis that is appropriate for treatment with the study medication covering =10% BSA
Subject has a PASI score =10.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subject has a history of sensitivity to any of the ingredients in the study medication
Subject is currently participating in, or has within the 30 days prior to the clinical trial participated in an investigational clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the dose-ranging response in safety and efficacy of R115866 0.5 mg, 1 mg and 2 mg and R115866 placebo given once daily for the treatment of subjects with plaque psoriasis to select a dose for further clinical development.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is success in the PASI, defined as a 75% or greater reduction from baseline (Visit 2) at the end of treatment Visit 6 (week 12).
- Secondary Outcome Measures
Name Time Method