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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• 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.