Clinical trial NCT01200264: Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
timeFrame: 6 mos. treatment and 1 month F/U post treatment
Secondary outcomes:
measure: Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.
timeFrame: Treatment course of 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John C Murray, MD
role: PRINCIPAL_INVESTIGATOR
References: