Apremilast for Atopic Dermatitis - A Pilot Study in Adults
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Apremilast
Intervention description: 20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 20mg cohort enrolled and completed before the 30mg cohort enrolled.
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.