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NCT05858619 Clinical Trial

Molecular Signatures of Cutaneous Dupilumab Response

Atopic Dermatitis Clinical Trial

Official title:
Molecular Signatures of Cutaneous Dupilumab Response

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05858619
Other study ID # 21-35748
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2026

Study information
Verified date May 2023
Source University of California, San Francisco
Contact Jeffrey Cheng, MD, PhD
Phone 415 575 0524
Email rashes@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date February 1, 2026
Est. primary completion date February 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dupilumab
dupilumab

Locations
Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Eczema Area and Severity Index (EASI) score from baseline to 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. baseline and 8-12 weeks
See also
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