It is clear that there is dynamic interplay between the immune system, skin barrier function, and the skin bacterial flora, and these interactions are likely driving some, if not all, of the clinical features associated with atopic dermatitis. This clinical trial assesses the effect of dupilumab in treating the skin of adults with chronic moderate to severe atopic dermatitis or eczema.
What does the study involve?
Participants will be randomly selected to receive either dupilumab or a placebo by injection. Neither the participants nor the study team members will know which group the participants are in during the first six weeks of the study, when they will come for seven scheduled visits. During the final 10 weeks of the study all participants will receive dupilumab. Study procedures include: blood, urine, and skin sample collection, including skin biopsies; and skin barrier assessments. Participants may be asked to return for unscheduled visits, as needed.
Who can participate?
You may be eligible to participate in this study if:
- You are 18 to 65 years of age
- You have had chronic atopic dermatitis for at least 3 years before the screening visit
- You have active lesions on the upper or lower extremities, excluding the palms and soles
- You have documented recent history (within 6 months of the screening visit) of inadequate response to topical corticosteroids or if topical treatments are inadvisable for you
Where is the study taking place?
The study is being conducted at research centers across the United States. Visit clinicaltrials.gov to see the list of locations and contact information.
How much does it cost?
There is no charge to participate in this research study. All study-related medical care, including clinic visits and procedures, are provided free of charge.
Will I receive payment?
Financial compensation will be provided to study participants. Travel expenses may be reimbursed.
To learn more about the clinical trial entitled, “Effect of Dupilumab (anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis” (trial ID: NCT03389893), visit clinicaltrials.gov.