Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Withdrawn before enrolling · Phase 2
Conditions studied: Chronic Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT01200264
- Run by
- Duke University
- People needed
- 0
- Starts
- 2010-09-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2014-07-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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