Back to resultsApremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Primary Purpose
Chronic Plaque Psoriasis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
apremilast for all subjects
Arm Description
Outcomes
Primary Outcome Measures
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
Secondary Outcome Measures
Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01200264
Brief Title
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Contract never executed; withdrawn by sponsor
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
apremilast for all subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
apremilast
Other Intervention Name(s)
CC-1004
Intervention Description
apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
Primary Outcome Measure Information:
Title
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
Time Frame
6 mos. treatment and 1 month F/U post treatment
Secondary Outcome Measure Information:
Title
Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.
Time Frame
Treatment course of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Murray, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
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