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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:
ClinicalTrials.gov Identifier:
NCT00606450
First Posted: February 4, 2008
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:

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 ]

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 ]
  • 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 ]

Enrollment: 260
Actual Study Start Date: April 1, 2006
Study Completion Date: May 1, 2007
Primary Completion Date: February 1, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Czechia
Department of Dermatology
Brno, Czechia
Department of Dermatology
Hradec Kralove, Czechia
Department of Dermatovererology
Olomouc, Czechia
Department of Dermatovererology
Praha, Czechia
Depart of Dermatology
Usti nad Labem, Czechia
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
Investigators
Study Director: Randall Stevens Celgene Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00606450     History of Changes
Other Study ID Numbers: CC-10004-PSOR-003
First Submitted: January 22, 2008
First Posted: February 4, 2008
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Celgene:
plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents