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NCT Number: NCT05858619

Molecular Signatures of Cutaneous Dupilumab Response

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jeffrey Cheng, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Dupilumab

Drug

dupilumab 600 mg injection initially and then 300 mg every other week

Primary outcomes

  1. Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks

    Time frame: baseline and 8-12 weeks

    Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Cheng, MD, PhD

CONTACT

[email protected]

415 575 0524

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 15, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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