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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: apremilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apremilast for all subjects<br> | Drug: apremilast<br>* apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days<br>* Other names: CC-1004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy |  | 6 mos. treatment and 1 month F/U post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin. |  | Treatment course of 6 months |