Treatment of Plaque Psoriasis
Conditions
Interventions
Product Name: R115866
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Not assigned
CAS Number: 201410-66-4
Current Sponsor code:
Sponsors
Barrier Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 did not respond to at least one previous form of therapy 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Ireland, Netherlands, United Kingdom
Outcome results
None listed