drugset / Trial / NCT01200264

Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy

NCT01200264

Phase 2 Withdrawn Duke University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-09
Primary completion
2011-12
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Apremilast Small molecule 30 mg

Indications