Purpose of this Study
We are doing this study to find out if a new drug called dupilumab (the study drug) is a safe and effective option for people with atopic dermatitis who have darker skin tones. Specific information about the skin tones relevant to this study is included in the eligibility section below.
Who Can Participate?
Eligibility
Adults and children ages 12+ who:
- Are diagnosed with atopic dermatitis
- Have skin tone that is classified as 4, 5, or 6 on the Fitzpatrick scale
You can assess your skin tone according to the Fitzpatrick scale on the National Library of Medicine’s website: https://www.ncbi.nlm.nih.gov/books/NBK481857/table/chapter6.t1/
For more information about this study, please contact the study team at connor.whatley@duke.edu.
- Are diagnosed with atopic dermatitis
- Have skin tone that is classified as 4, 5, or 6 on the Fitzpatrick scale
You can assess your skin tone according to the Fitzpatrick scale on the National Library of Medicine’s website: https://www.ncbi.nlm.nih.gov/books/NBK481857/table/chapter6.t1/
For more information about this study, please contact the study team at connor.whatley@duke.edu.
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you or your child choose to join this study, your/their participation will last for up to 29 weeks (includes a screening period of up to 5 weeks to confirm that you/they are eligible). If you/they are eligible, you/they will take the study drug as an injection (shot) every 2 weeks. You/your child will get the study drug in our clinic the first time, and we will teach you how to give yourself or your child the shots at home for the remaining doses. Study participants will get up to 12 doses of the study drug.
Study participants will visit our clinic at least 9 times during the study, which includes the screening period. During these visits, you/your child will:
- Have a physical exam
- Have blood draws
- Answer questionnaires
Study participants will visit our clinic at least 9 times during the study, which includes the screening period. During these visits, you/your child will:
- Have a physical exam
- Have blood draws
- Answer questionnaires
Locations
Duke University Hospital
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult
Skin of Color Patients with Moderate-to-Severe Atopic Dermatitis
Skin of Color Patients with Moderate-to-Severe Atopic Dermatitis
Principal Investigator
Meenal
Kheterpal
Protocol Number
PRO00112395
NCT ID
NCT05590585
Phase
IV
Enrollment Status
OPEN TO ACCRUAL