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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: CC-10004
* Drug: CC-10004
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 mg Apremilast daily<br>20 mg of CC-10004 daily | Drug: CC-10004<br>* 20 mg CC-10004 taken 1 time per day for 12 weeks<br>* Other names: Apremilast;|
| Experimental: 20mg Apremilast twice daily<br>CC-10004 twice daily | Drug: CC-10004<br>* 20 mg of CC-10004 taken 2 times per day for 12 weeks<br>* Other names: Apremilast;|
| Placebo Comparator: Placebo<br>Placebo arm | Drug: Placebo<br>* matching placebo taken either 1 or 2 times per day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque psoriasis