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

Chronic Plaque Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01200264
• Other study ID #: Pro00025452
• Secondary ID: AP00039
• Status: Withdrawn
• Phase: Phase 2
• First received: September 10, 2010
• Last updated: July 14, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2010
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• apremilast
apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.		Treatment course of 6 months	No