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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00606450
First received: January 22, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CC-10004
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

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

Secondary Outcome Measures:
  • To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Apremilast
Experimental: 20mg Apremilast twice daily
CC-10004 twice daily
Drug: CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Other Name: Apremilast
Placebo Comparator: Placebo
Placebo arm
Drug: Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00606450

Locations
Canada, Alberta
Division of Dermatology and Cutaneous Science
Edmonton, Alberta, Canada
Canada, British Columbia
Division of Dermatology
Vancouver, British Columbia, Canada
Canada, New Brunswick
Duronder C.P. Inc
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Ultranova Skincare
Barrie, Ontario, Canada, L4M 6L2
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6
The Lynde Center for Dermatology
Markham, Ontario, Canada, L3P 7N8
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
K. Papp Clinical Research
Waterloo, Ontario, Canada, L3P 7N8
Canada, Quebec
Innovaderm
Montreal, Quebec, Canada, H2K 4L5
Dr Yves Poulin
Quebec City, Quebec, Canada, G1V 4X7
Czech Republic
Department of Dermatology
Brno, Czech Republic
Department of Dermatology
Hradec Kralove, Czech Republic
Department of Dermatovererology
Olomouc, Czech Republic
Department of Dermatovererology
Praha, Czech Republic
Depart of Dermatology
Usti nad Labem, Czech Republic
Germany
Celgene Clinical Site
Ausburg, Germany
Celgene Clinical Site
Berlin, Germany
Department of Dermatologie and Venerology
Dresden, Germany
Department of Dermatology and Venerology
Frankfurt Main, Germany
Celgene Clinical Site
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
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Randall Stevens Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00606450     History of Changes
Other Study ID Numbers: CC-10004-PSOR-003
Study First Received: January 22, 2008
Last Updated: May 29, 2013
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: Ethics Committee

Keywords provided by Celgene Corporation:
plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014