Double-Blind, Randomized, Placebo-Controlled Comparison of CC10004 in Subjects With Moderate to Severe Plaque Type Psoriasis - Full Text View

Purpose

There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC10004 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 CC10004.

Condition	Intervention	Phase
Psoriasis	Drug: CC10004 Drug: Placebo	Phase II

MedlinePlus related topics:

Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Comparison Study of CC10004 in Subjects With Moderate-to-Severe Plaque-Type Psoriasis

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

To compare the clinical efficacy of 2 oral doses of CC10004 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 CC10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the effects of CC10004 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
1: Active Comparator 20 mg of CC10004 QD	Drug: CC10004 20 mg CC 10004 taken 1 time per day for 12 weeks
2: Active Comparator CC10004 BID	Drug: CC10004 20 mg of CC10004 taken 2 times per day for 12 weeks
3: Placebo Comparator Placebo arm	Drug: Placebo matching placebo taken either 1 or 2 times per day for 12 weeks

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 PASI score greater than or equal to 10 and 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

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
	North Bay Dermatology Centre
	North Bay, Ontario, Canada, P1B3Z7
	K. Papp Clinical Research
	Waterloo, Ontario, Canada, L3P 7N8
	Ultranova Skincare
	Barrie, Ontario, Canada, L4M 6L2
	The Lynde Center for Dermatology
	Markham, Ontario, Canada, L3P 7N8
	Dermatrials Research
	Hamilton, Ontario, Canada, L8N 1V6

Canada, Quebec
	Dr Yves Poulin
	Quebec City, Quebec, Canada, G1V 4X7
	Innovaderm
	Montreal, Quebec, Canada, H2K 4L5

Czech Republic
	Department of Dermatovererology
	Praha, Czech Republic
	Department of Dermatology
	Hradec Kralove, Czech Republic
	Department of Dermatology
	Brno, Czech Republic
	Depart of Dermatology
	Usti nad Labem, Czech Republic
	Department of Dermatovererology
	Olomouc, Czech Republic

Germany
	Department of Dermatology and Venerology
	Frankfurt Main, Germany

	Schwerin, Germany

	Salzwedel, Germany

	Munster, Germany

	Herborn, Germany

	Berlin, Germany

	Ausburg, Germany

	Leipzig, Germany

	Homburg, Germany

	Wiesbaden, Germany

	Hamburg, Germany

	Mannheim, Germany

	Heidelberg, Germany

	Berlin, Germany

	Berlin, Germany

	Wurzburg, Germany

	Hamburg, Germany
	Department of Dermatologie and Venerology
	Dresden, Germany

Sponsors and Collaborators

Celgene Corporation

More Information

Responsible Party:	Celgene Corporation ( Patricia Rohane, MD )
Study ID Numbers:	CC-10004-PSOR-003
First Received:	January 22, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00606450
Health Authority:	United States: Institutional Review Board; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: Ethics Committee

Keywords provided by Celgene Corporation:

plaque psoriasis

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00606450