Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | September 2010 |
| End Date: | September 2012 |
| Contact: | John C Murray, MD |
| Email: | murra013@mc.duke.edu |
| Phone: | 919-684-2393 |
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.
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.
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.
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
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