Psoriasis
Conditions
Keywords
plaque 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.
Interventions
DRUGCC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
DRUGPlacebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis | 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. | 12 weeks |
Countries
Canada, Czechia, Germany
Outcome results
None listed