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

NCT01200264 | Withdrawn Phase 2

• 2 other identifiers: Pro00025452AP00039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.

  Treatment course of 6 months

Study Arms (1)

apremilast for all subjects

EXPERIMENTAL

Drug: apremilast

Interventions

apremilast DRUG

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

Also known as: CC-1004

apremilast for all subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

apremilast

Study Officials

• John C Murray, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: July 15, 2014

Record last verified: 2010-09

Locations

US (1)