Double-Blind, Randomized, Placebo-controlled Comparison o... | NCT00606450

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
20 mg Apremilast daily	Experimental	20 mg of CC-10004 daily	Drug: CC-10004
20mg Apremilast twice daily	Experimental	CC-10004 twice daily	Drug: CC-10004
Placebo	Placebo Comparator	Placebo arm	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CC-10004	Drug	20 mg CC-10004 taken 1 time per day for 12 weeks	20 mg Apremilast daily

Outcomes Module

Primary Outcomes

Measure	Description	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		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis		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.

Eligibility Module

Eligibility 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

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Division of Dermatology and Cutaneous Science		Edmonton	Alberta		Canada
Division of Dermatology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23030767	Background	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.

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases