Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis (PSOR-003)

April 22, 2020 updated by: Amgen

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Comparison Study of CC-10004 in Subjects With Moderate-to-Severe Plaque-Type Psoriasis

There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The information obtained from the study will aid in the design of future clinical trials and to establish the safety and efficacy of CC-10004.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Division of Dermatology and Cutaneous Science
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Division of Dermatology
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Duronder C.P. Inc
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
        • Eastern Canada Cutaneous Research Associates
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skincare
      • Hamilton, Ontario, Canada, L8N 1V6
        • Dermatrials Research
      • Markham, Ontario, Canada, L3P 7N8
        • The Lynde Center for Dermatology
      • North Bay, Ontario, Canada, P1B3Z7
        • North Bay Dermatology Centre
      • Waterloo, Ontario, Canada, L3P 7N8
        • K. Papp Clinical Research
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm
      • Quebec City, Quebec, Canada, G1V 4X7
        • Dr Yves Poulin
  • Czechia
      • Brno, Czechia
        • Department of Dermatology
      • Hradec Kralove, Czechia
        • Department of Dermatology
      • Olomouc, Czechia
        • Department of Dermatovererology
      • Praha, Czechia
        • Department of Dermatovererology
      • Usti nad Labem, Czechia
        • Depart of Dermatology
  • Germany
      • Ausburg, Germany
        • Celgene Clinical Site
      • Berlin, Germany
        • Celgene Clinical Site
      • Dresden, Germany
        • Department of Dermatologie and Venerology
      • Frankfurt Main, Germany
        • Department of Dermatology and Venerology
      • Hamburg, Germany
        • Celgene Clinical Site
      • Heidelberg, Germany
        • Celgene Clinical Site
      • Herborn, Germany
        • Celgene Clinical Site
      • Homburg, Germany
        • Celgene Clinical Site
      • Leipzig, Germany
        • Celgene Clinical Site
      • Mannheim, Germany
        • Celgene Clinical Site
      • Munster, Germany
        • Celgene Clinical Site
      • Salzwedel, Germany
        • Celgene Clinical Site
      • Schwerin, Germany
        • Celgene Clinical Site
      • Wiesbaden, Germany
        • Celgene Clinical Site
      • Wurzburg, Germany
        • Celgene Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must understand and voluntarily sign and informed consent form
  • Must be in good health as judged by the investigator
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
  • Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
  • Must meet specific laboratory criteria
  • Must be a candidate for photo/systemic therapy
  • Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

  • Must not have clinically significant underlying disease processes
  • Must not be pregnant or lactating females
  • Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
  • Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
  • Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
  • Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
  • Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
  • Must not have current erythrodermic, guttate, or pustular psoriasis
  • Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
  • Must not use topical therapy within 14 days of randomization
  • Must not use systemic therapy for psoriasis within 28 days of randomization
  • Must not use phototherapy within 28 days of randomization
  • Must not use adalimumab or infliximab within 3 months of randomization
  • Must not use etanercept or efalizumab within 56 days of randomization
  • Must not use alefacept within 6 months of randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo arm
Drug: Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Experimental: 20 mg Apremilast daily
20 mg of CC-10004 daily
Drug: CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
Other Names:
  • Apremilast
Drug: CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Other Names:
  • Apremilast
Experimental: 20mg Apremilast twice daily
CC-10004 twice daily
Drug: CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
Other Names:
  • Apremilast
Drug: CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Other Names:
  • Apremilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the clinical efficacy of 2 oral doses of CC-10004 with placebo when taken for 12 weeks in subjects with moderate-to-severe plaque-type psoriasis
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
Time Frame: 12 weeks
12 weeks
To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-10004-PSOR-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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