Apremilast for Atopic Dermatitis - A Pilot Study in Adults

NCT01393158 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AP-PI-AD-0034
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in EASI Scores

  The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.

  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 (3)

• Number of Participants in Each IGA Category

  Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

• Change in Pruritus (Visual Analog Scale) Score

  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)

• Change In DLQI Scores

  Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

Study Arms (2)

20 mg BID

EXPERIMENTAL

Patients dosed with 20 mg orally of Apremilast BID for 3 months.

Drug: Apremilast

30 mg BID

EXPERIMENTAL

Patients dosed with 30 mg orally of Apremilast BID for 6 months.

Drug: Apremilast

Interventions

Apremilast DRUG

20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.

Also known as: Otezla

20 mg BID; 30 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Celgene Corporation: collaborator

Related Publications (1)

• 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.

  PMID: 22508772 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Eric Simpson,
• Organization: Oregon Health & Science University

simpsone@ohsu.edu

503-494-2121

Study Officials

• Eric L Simpson, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dermatology

Model Details: 20mg cohort enrolled and completed before the 30mg cohort enrolled.

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: May 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2019-12