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Study Complete
Sponsor ID
CC-10004-PSOR-003

Double-Blind, Randomized, Placebo-controlled comparison of CC-10004 in Subjects with Moderate to Severe Plaque Type PsoriasisPSOR-003

Sponsor ID
CC-10004-PSOR-003
Clinicaltrials.gov ID
NCT00606450
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
260
Additional Study Details

Protocol Summary

Primary Outcome Measures

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 Outcome Measures

To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis

Timeframe: 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.

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Dr Yves Poulin
Quebec City, Quebec, Canada, G1V 4X7
Status
Completed
Location
Innovaderm
Montreal, Quebec, Canada, H2K 4L5
Status
Completed
Location
The Lynde Center for Dermatology
Markham, Ontario, Canada, L3P 7N8
Status
Completed
Location
K. Papp Clinical Research
Waterloo, Ontario, Canada, L3P 7N8
Status
Completed
Location
Ultranova Skincare
Barrie, Ontario, Canada, L4M 6L2
Status
Completed
Location
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Apr 2006 - Feb 2007
    Inclusion and Exclusion 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