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

• Status: Withdrawn
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Apremilast; Thalidomide

Criteria

Inclusion Criteria:

• Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy

• Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'

• Must meet lab criteria per Pg 20-21 of protocol

• All subjects must follow contraceptive measures as described in protocol, Pg 21.

Exclusion Criteria:

• Abnormal Chest x-ray

• Significant abnormality of ECG

• Positive HIV Ab, Hepatitis B & C

• Subjects with erythrodermic, pustular or guttate psoriasis are ineligible

• Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast