Apremilast for Atopic Dermatitis - A Pilot Study in Adults

A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults

The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.

To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.

Inclusion Criteria:

• Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment.
• Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease.
• Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30.
• Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
• Subjects must meet the washout requirements

Exclusion Criteria:

• 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.
• At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years.
• Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable.
• Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
• Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening.
• History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]).
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
• History of Human Immunodeficiency Virus (HIV) infection.
• Antibodies to Hepatitis C at screening.
• History of squamous cell carcinoma of the skin and thin melanoma.
• Systemic corticosteroid-dependent asthma.
• Active infection of any type at the time of enrollment.