Purpose:

The purpose of this study is to demonstrate how safe and effective dupilumab is in patients ≥ 12 years to    ≤ 18 years of age with moderate to severe Atopic Dermatitis.  This drug is not yet approved for sale by government agencies, such as the US Food and Drug Administration (FDA).

 

Study Summary:

Patients who have been diagnosed with moderate to severe atopic dermatitis among other eligibility criteria will be randomly placed into one of three groups based on weight after a washout period of topical or oral steroids. The medication is an injection given every other week. The length of the study is 28 weeks with visits every week for the first 4 weeks and then once monthly.  Subjects will be required to have interval blood and urine testing as well as a baseline EKG.  Patient diaries and scales will be will be used as assessment tools. Safety will be assessed by vital signs and laboratory testing. Patients will be required to complete e-diaries at home between study visits.

Basic Eligibility Criteria:

Informed consent must be obtained and assent (if necessary). Patients must be age ≥ 12 years to    ≤ 18 years of age with moderate to severe Atopic Dermatitis diagnosed at least one year prior to screening visit. Assessment scales will be completed at screening and baseline visits to determine eligibility. Patients have to have failed therapy with topical atopic dermatitis medications within the last 6 months. Patients must be willing and able to comply with all clinic visits and study-related procedures.  Patients must not have participated in a previous dupilumab clinical study or been treated with any other systemic investigational drug before the baseline visit. Patients will have to stop all topical atopic dermatitis medications two weeks prior to the baseline visit. Patients cannot be taking any immune suppressing agents or biologics, or have been diagnosed with any type of immune deficiency/infection. Patient must not have been diagnosed with liver disease or have specific abnormal lab values. Patients must ben free of any other skin comorbidities and may not have any history of malignancy. History of drug or alcohol abuse within 2 years of screening is prohibited Pregnancy or breastfeeding during the study is not allowed. Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception will be excluded. A form of contraception must be used for the duration of the study and 120 days after the last dose of study drug.

Study Location(s):

Phoenix Children's Hospital/Department of Dermatology

Study Contacts:

Kellie Badger RN 602-933-2053

Emily Cantwell RN 602-933-2775

 

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