Spatial And Multiomic Profiling Of Atopic Dermatitis

Overview

About this study

The purpose of this study is to evaluate key clinical, microbial, histological, and skin imaging biomarkers in patients with moderate-to-severe atopic dermatitis and perform comprehensive molecular profiling before and after treatment.

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:

  • Male and female adults aged ≥18 years (at the screening visit) with capacity to consent who are initiating treatment with either dupilumab or a JAKi.

  • Moderate-to-severe AD (EASI≥16 or IGA ≥3).

  • AD duration of at least 3 months.

  • Systemic treatment naïve or no systemic treatments in the preceding 3 months.

  • No topical treatment use in the preceding 2 weeks.

  • At least 1 target lesion that measures at least 2 cm2 at first visit. The target lesion must be representative of the participant's disease state but not located on the hands, feet, genitalia, face, scalp, or intertriginous areas.

Exclusion Criteria:

  • Unstable history of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline/visit 0.

  • Disease history concerns, i.e., lymphoma, immunodeficiency, chronic infections such as HIV, hepatitis, or tuberculosis, dialysis, and/or history of skin cancer within 5 years.

  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline/visit 0.

  • Active acute bacterial, fungal, or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox, clinically infected AD, impetigo) within 1 week before the baseline/visit 0.

  • Insufficient area of uninvolved (control) skin.

  • Relative contraindications to skin biopsy (e.g., serum platelets <10; allergy to lidocaine)

  • AD exclusive to areas of the hands, feet, face, scalp, intertriginous areas, or genitalia.

  • Inability to proceed with follw-up biopsy after 16-20 weeks of treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/03/2025. 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

Rochester, Minn.

Mayo Clinic principal investigator

Dawn Marie Davis

Open for enrollment

Contact information:

Jessica Hafeman

(507) 422-6964

AtDtrial@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20597401

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