Apremilast for Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393158
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Celgene Corporation
Information provided by:
Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Apremilast Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Apremilast
One-arm study
Drug: Apremilast
30 mg by mouth twice daily for a total of 124 weeks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01393158     History of Changes
Other Study ID Numbers: AP-PI-AD-0034
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: April 2010

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents