Study of Apremilast in Atopic or Contact Dermatitis

Inclusion Criteria

• Must understand and voluntarily sign an informed consent form.
• Must be male or female and aged ≥ 18 years at time of consent.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Must have a documented history of contact or atopic dermatitis for at least 3 months prior to screening visit. Subjects will be asked to bring records at the time of screening visit; if they do not bring these records, subjects will be asked to complete and sign a release of records for which will be sent to the subject's physician. The Investigators will review records to confirm eligibility prior to enrolling a subject into the study.
• Subjects must fulfill criteria outlined in at least one of the following clinical categories:
• Unresponsive to standard systemic or topical therapy, as defined by clinical history, in the investigator's opinion, i.e. inadequate response to one or more adequate treatment course (s) of standard systemic therapy including but not limited to: topical steroids, ultraviolet light A [UVA], narrowband ultraviolet B (NBUVB), ultraviolet light B [UVB].
• Intolerant to or cannot receive (e.g., contraindication to prescribe) standard systemic or topical therapy for contact or atopic dermatitis.
• Must have a IGA score of at least moderate (3 on a 0 to 5 point scale) at screening.
• Must meet the following laboratory criteria:
• White blood cell count ≥ 3000/ μL (3 x 109/L) and 100,000/ μL (100 x 109/L)
• Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
• AST (SGOT) and ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN)
• Hemoglobin > 9 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening. In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication:
• oral, injectable, or implantable hormonal contraceptives;
• tubal ligation;
• intrauterine device;
• barrier contraceptive with spermicide;
• vasectomized partner while on study.
• A FCBP must agree to have pregnancy tests every 4 weeks while on study medication.
• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication.

Exclusion Criteria

• Inability to provide voluntary consent.
• History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease. Potential subjects with severe uncontrolled conditions, such as severe uncontrolled diabetes, will be excluded.
• 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.
• Pregnant or breastfeeding.
• Systemic fungal infection.
• History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
• Latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
• If QuantiFERON® test is performed instead of the PPD test, only those with a negative QuantiFERON® test are allowed in the study.
• History of incompletely treated Mycobacterium tuberculosis infection as indicated by:
• Subject's medical rec