Clinical trial NCT00604682 (phase 2, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: cc10004
SMILES: [H][C@](CS(C)(=O)=O)(N1C(=O)C2=C(C1=O)C(=CC=C2)N=C(C)O)C1=CC(OCC)=C(OC)C=C1
Eligibility criteria:

        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