Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
NCT ID: NCT00606450
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2006-04-01
2007-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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20 mg Apremilast daily
20 mg of CC-10004 daily
CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
20mg Apremilast twice daily
CC-10004 twice daily
CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Placebo
Placebo arm
Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Interventions
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CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Division of Dermatology and Cutaneous Science
Edmonton, Alberta, Canada
Division of Dermatology
Vancouver, British Columbia, Canada
Duronder C.P. Inc
Moncton, New Brunswick, Canada
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, Canada
Ultranova Skincare
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
The Lynde Center for Dermatology
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm
Montreal, Quebec, Canada
Dr Yves Poulin
Québec, Quebec, Canada
Department of Dermatology
Brno, , Czechia
Department of Dermatology
Hradec Králové, , Czechia
Department of Dermatovererology
Olomouc, , Czechia
Department of Dermatovererology
Prague, , Czechia
Depart of Dermatology
Ústí nad Labem, , Czechia
Celgene Clinical Site
Ausburg, , Germany
Celgene Clinical Site
Berlin, , Germany
Department of Dermatologie and Venerology
Dresden, , Germany
Department of Dermatology and Venerology
Frankfurt am 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
Münster, , Germany
Celgene Clinical Site
Salzwedel, , Germany
Celgene Clinical Site
Schwerin, , Germany
Celgene Clinical Site
Wiesbaden, , Germany
Celgene Clinical Site
Würzburg, , Germany
Countries
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References
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Papp KA, Kaufmann R, Thaci D, Hu C, Sutherland D, Rohane P. Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e376-83. doi: 10.1111/j.1468-3083.2012.04716.x. Epub 2012 Oct 3.
Other Identifiers
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CC-10004-PSOR-003
Identifier Type: -
Identifier Source: org_study_id
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