Clinical trial NCT00606450: Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: plaque psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-02-04
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
timeFrame: 12 weeks
measure: To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Division of Dermatology and Cutaneous Science
state: Alberta
city: Vancouver
country: Canada
facility: Division of Dermatology
state: British Columbia
city: Moncton
country: Canada
facility: Duronder C.P. Inc
state: New Brunswick
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates
state: Nova Scotia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Markham
country: Canada
facility: The Lynde Center for Dermatology
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm
state: Quebec
city: Quebec City
country: Canada
facility: Dr Yves Poulin
state: Quebec
city: Brno
country: Czechia
facility: Department of Dermatology
city: Hradec Kralove
country: Czechia
facility: Department of Dermatology
city: Olomouc
country: Czechia
facility: Department of Dermatovererology
city: Praha
country: Czechia
facility: Department of Dermatovererology
city: Usti nad Labem
country: Czechia
facility: Depart of Dermatology
city: Ausburg
country: Germany
facility: Celgene Clinical Site
city: Berlin
country: Germany
facility: Celgene Clinical Site
city: Dresden
country: Germany
facility: Department of Dermatologie and Venerology
city: Frankfurt Main
country: Germany
facility: Department of Dermatology and Venerology
city: Hamburg
country: Germany
facility: Celgene Clinical Site
city: Heidelberg
country: Germany
facility: Celgene Clinical Site
city: Herborn
country: Germany
facility: Celgene Clinical Site
city: Homburg
country: Germany
facility: Celgene Clinical Site
city: Leipzig
country: Germany
facility: Celgene Clinical Site
city: Mannheim
country: Germany
facility: Celgene Clinical Site
city: Munster
country: Germany
facility: Celgene Clinical Site
city: Salzwedel
country: Germany
facility: Celgene Clinical Site
city: Schwerin
country: Germany
facility: Celgene Clinical Site
city: Wiesbaden
country: Germany
facility: Celgene Clinical Site
city: Wurzburg
country: Germany
facility: Celgene Clinical Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.