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

Duke University

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: apremilast

Study type: Interventional

Funder types: Other

Identifiers

NCT01200264

Pro00025452

AP00039

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

apremilast for all subjects

Experimental group

Treatment:

Drug: apremilast