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

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab; Other: Photo therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05372003

22-002567

Details and patient eligibility

About

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.

Full description

Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).

Enrollment: 7 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Subjects on Dupilumab

Experimental group

Description:

individuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy"

Treatment:

Drug: Dupilumab

Subjects on Phototherapy

Active Comparator group

Description:

individuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab"

Treatment:

Other: Photo therapy