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

Phase 2

Withdrawn

• Conditions: Chronic Plaque Psoriasis
• Interventions: Drug: apremilast

• Registration Number: NCT01200264
• Lead Sponsor: Duke University

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apremilast for all subjects	apremilast	-

Primary Outcome Measures

Name	Time	Method
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy	6 mos. treatment and 1 month F/U post treatment

Secondary Outcome Measures

Name	Time	Method
Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.	Treatment course of 6 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States