Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis (PSOR-001)

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis Read More

Inclusion Criteria

• Must understand and voluntarily sign an informed consent form
• Must be age > or = to 18 years to 65 years at the time of singing the informed consent form.
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
• Must meet the following clinical laboratory criteria:
• White Blood Cell Count > or = to 3000/cu mm and < 20,000/cu mm
• Platelet count > or = to 100,000/microliters
• Serum creatinine < or = to 1.5 mg/dl
• Total bilirubin < or = to 2.0 mg/dl
• AST (SGOT) and ALT (SGPT) < or = to 1.5 X ULN
• Must have a psoriatic plaque > or = to 2.5 cm in diameter (for biopsy)
• Must be candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if a clinician judges that the subject requires any systemic therapy (e.g., ultraviolet light B(UVB), Psoralens and long-wave ultraviolet radiation (PUVA), cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine)to control psoriasis whether or not that subject has a history of receiving systemic therapy)
• Women of child bearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use two forms of adequate forms on contraception throughout the trial.

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