Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Apremilast in Atopic or Contact Dermatitis

NCT00931242

Atopic Dermatitis Allergic Contact Dermatitis

COMPLETED PHASE2

Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

NCT02087943

Dermatitis, Atopic Dermatitis

COMPLETED PHASE2

An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema

NCT03160248

Nummular Eczema Eczema Dermatitis Eczema +1 more

COMPLETED PHASE2

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

NCT03915496

Atopic Dermatitis

COMPLETED PHASE2

Apremilast and Moderate to Severe Chronic Hand Dermatitis

NCT03741933

Chronic Hand Dermatitis

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

20mg cohort enrolled and completed before the 30mg cohort enrolled.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

20 mg BID

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

Group Type EXPERIMENTAL

Apremilast

Intervention Type DRUG

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

30 mg BID

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

Group Type EXPERIMENTAL

Apremilast

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apremilast

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Otezla

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No