Clinical trial NCT01393158: Apremilast for Atopic Dermatitis - A Pilot Study in Adults
Official title: A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-07-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 20mg cohort enrolled and completed before the 30mg cohort enrolled.
Primary purpose: TREATMENT

Brief 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.

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

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.

Primary outcomes:
measure: Change in EASI Scores
timeFrame: Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
Secondary outcomes:
measure: Number of Participants in Each IGA Category
timeFrame: Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
measure: Change in Pruritus (Visual Analog Scale) Score
timeFrame: Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
measure: Change In DLQI Scores
timeFrame: Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Eric L Simpson, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samrao A, Berry TM, Goreshi R, Simpson EL. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Arch Dermatol. 2012 Aug;148(8):890-7. doi: 10.1001/archdermatol.2012.812.