Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.|
- Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy [ Time Frame: 6 mos. treatment and 1 month F/U post treatment ] [ Designated as safety issue: Yes ]
- Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin. [ Time Frame: Treatment course of 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: apremilast for all subjects||
apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
Other Name: CC-1004
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report.
Data & Safety Monitoring Dr. Murray will be following all laboratory values and adverse events during this trial. In addition, Celgene will provide a study monitor to, at regular intervals, review all data. All data will be reported to Celgene.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||John C Murray, MD||Duke University|