Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT01200264
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Chronic Plaque Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- apremilast — DRUGapremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
Study Details
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.
Key Dates
- First listed
- Sep 13, 2010
- Start date
- Sep 30, 2010
- Status verified
- Sep 2010
- Primary completion
- Dec 31, 2011
- Completion
- Sep 30, 2012
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: apremilast for all subjects
Primary Outcome Measure
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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | - |