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Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis (PSOR-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606450
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 4, 2008
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE April 1, 2006
Actual Primary Completion Date February 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
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 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis [ Time Frame: 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. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: CC-10004
    20 mg CC-10004 taken 1 time per day for 12 weeks
    Other Name: Apremilast
  • Drug: CC-10004
    20 mg of CC-10004 taken 2 times per day for 12 weeks
    Other Name: Apremilast
  • Drug: Placebo
    matching placebo taken either 1 or 2 times per day for 12 weeks
Study Arms  ICMJE
  • Experimental: 20 mg Apremilast daily
    20 mg of CC-10004 daily
    Intervention: Drug: CC-10004
  • Experimental: 20mg Apremilast twice daily
    CC-10004 twice daily
    Intervention: Drug: CC-10004
  • Placebo Comparator: Placebo
    Placebo arm
    Intervention: Drug: Placebo
Publications * Papp KA, Kaufmann R, Thaçi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2008)
260
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2007
Actual Primary Completion Date February 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Germany
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00606450
Other Study ID Numbers  ICMJE CC-10004-PSOR-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP