Molecular Signatures of Cutaneous Dupilumab Response

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05858619

21-35748

Details and patient eligibility

About

This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

Full description

This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7

Exclusion criteria

1. Known pregnancy
2. Known immunodeficiencies
3. Known parasitic infection -

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

dupilumab treatment

Experimental group

Description:

Treatment with IL4RA inhibitor

Treatment:

Drug: Dupilumab