Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
- Registration Number
- NCT00606450
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20 mg Apremilast daily CC-10004 20 mg of CC-10004 daily Placebo Placebo Placebo arm 20mg Apremilast twice daily CC-10004 CC-10004 twice daily
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis 12 weeks
Trial Locations
- Locations (17)
Innovaderm
🇨🇦Montreal, Quebec, Canada
Dr Yves Poulin
🇨🇦Quebec City, Quebec, Canada
Department of Dermatovererology
🇨🇿Praha, Czechia
Celgene Clinical Site
🇩🇪Wurzburg, Germany
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Division of Dermatology
🇨🇦Vancouver, British Columbia, Canada
Division of Dermatology and Cutaneous Science
🇨🇦Edmonton, Alberta, Canada
Duronder C.P. Inc
🇨🇦Moncton, New Brunswick, Canada
Ultranova Skincare
🇨🇦Barrie, Ontario, Canada
Department of Dermatology
🇨🇿Hradec Kralove, Czechia
The Lynde Center for Dermatology
🇨🇦Markham, Ontario, Canada
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Dermatrials Research
🇨🇦Hamilton, Ontario, Canada
Depart of Dermatology
🇨🇿Usti nad Labem, Czechia
Department of Dermatologie and Venerology
🇩🇪Dresden, Germany
Department of Dermatology and Venerology
🇩🇪Frankfurt Main, Germany
Eastern Canada Cutaneous Research Associates
🇨🇦Halifax, Nova Scotia, Canada