Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis
- Registration Number
- NCT00604682
- Lead Sponsor
- Amgen
- Brief Summary
Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
Not provided
Exclusion Criteria
- Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Current erythrodermic, guttate, or pustular psoriasis
- Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
- Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
- Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
- Use of systemic therapy for psoriasis
- Use or phototherapy within 28 days of study medication initiation
- Use Humira or Remicade within 3 months of study medication initiation
- Use of Enbrel within 56 days of study medication initiation
- Use of Raptiva within 56 days of study medication initiation
- Use of Amevive within 6 months of study medication initiation
- Use of any investigational drug within 30 days of study medication initiation or 5 half lives if known
- History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease or other major diseases
- Clinically significant abnormality on 12-lead ECG at screening
- Positive HIV, Hepatitis B or Hepatitis C laboratory result at screening
- History of active tuberculosis within previous 3 years
- Clinically significant abnormality on the chest x-ray at screening or on CXR taken within 6 months of screening
- History of positive purified protein derivative (PPD) test at screening
- History of malignancy within previous five years
- Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of CC10004 CC10004 -
- Primary Outcome Measures
Name Time Method To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis. 29 days
- Secondary Outcome Measures
Name Time Method To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases. 58 days To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis. 29 days To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis. 29 days
Trial Locations
- Locations (3)
University of Medicine and Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Mt Sinai School of Medicine
🇺🇸New York, New York, United States