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

This study has been withdrawn prior to enrollment.
(Contract never executed; withdrawn by sponsor)
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01200264
First received: September 10, 2010
Last updated: July 14, 2014
Last verified: September 2010
  Purpose

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 Intervention Phase
Chronic Plaque Psoriasis
Drug: apremilast
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200264

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

No publications provided

Responsible Party: John C. Murray, MD, Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01200264     History of Changes
Other Study ID Numbers: Pro00025452, AP00039
Study First Received: September 10, 2010
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014