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

• ClinicalTrials.gov Identifier: NCT00606450
• Recruitment Status: Completed
• First Posted: February 4, 2008
• Last Update Posted: April 24, 2020
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: January 22, 2008
• First Posted Date: February 4, 2008
• Last Update Posted Date: April 24, 2020
• Actual Study Start Date: April 1, 2006
• Actual Primary Completion Date: February 1, 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2008): 260
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 1, 2007
• Actual Primary Completion Date: February 1, 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Czechia, Germany
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT00606450
• Other Study ID Numbers: CC-10004-PSOR-003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amgen
• Study Sponsor: Amgen
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: April 2020