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)

Amgen

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: CC10004

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604682

CC-10004-PSOR-001

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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