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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Chronic Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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apremilast for all subjects

Group Type EXPERIMENTAL

apremilast

Intervention Type DRUG

apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days

Interventions

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apremilast

apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days

Intervention Type DRUG

Other Intervention Names

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CC-1004

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No