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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01200264
Recruitment Status : Withdrawn (Contract never executed; withdrawn by sponsor)
First Posted : September 13, 2010
Last Update Posted : July 15, 2014
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: apremilast Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: apremilast for all subjects Drug: apremilast
apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
Other Name: CC-1004

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01200264

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: John C Murray, MD Duke University

Responsible Party: John C. Murray, MD, Professor of Medicine, Duke University Medical Center Identifier: NCT01200264     History of Changes
Other Study ID Numbers: Pro00025452
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: September 2010

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents