IL-4 and Insulin Resistance for Treatment of Patients with Atopic Dermatitis

Overview

About this study

The objective of this study is to assess the metabolic effect of systemic inhibition of IL-4 signaling on insulin sensitivity in patients with atopic dermatitis by comparing in vivo evaluations of insulin sensitivity in subjects on dupilumab vs. subjects matched for similar adiposity, with atopic dermatitis, but without dupilumab therapy.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

InclusIon Criteria:

  • Age, 18-60 years old.
  • Ability to sign informed consent form.
  • Body mass index (BMI), 22-29 kg/m^2.
  • Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
  • Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.

Exclusion Criteria:

  • Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
  • Evidence of diabetes mellitus.
  • Morning Cortisol < 5 mg/dl (collected before 10.30 am).
  • Presence of acute illness.
  • Low hemoglobin or hematocrit.
  • Current participation in a weight-loss regimen, with a weight loss > 10% total body weight in the last 6 months).
  • Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).
  • Pregnant or breastfeeding.
  • Personal history of gastric bypass surgery.
  • Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).
  • Exposed to more than 4 new chemical entities within 12 months before study enrollment.
  • Any other condition or event considered exclusionary by the PI and the study physician.

Eligibility last updated 3/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elena Anna De Filippis, M.D., Ph.D.

Open for enrollment

Contact information:

Elena Anna De Filippis M.D., Ph.D.

(480) 301-4452

DeFilippis.Elena@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20532381

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