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Recruiting NCT05858619

Molecular Signatures of Cutaneous Dupilumab Response

Phase IV Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Drug Dupilumab
    dupilumab 600 mg injection initially and then 300 mg every other week

Primary outcome measures

  • Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks [Time frame: baseline and 8-12 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Known pregnancy
  • Known immunodeficiencies
  • Known parasitic infection -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT05858619 · 21-35748

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗