Molecular Signatures of Cutaneous Dupilumab Response

Phase 4RecruitingNCT05858619

University of California, San Francisco15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

DupilumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: baseline and 8-12 weeks

Central Contacts

Jeffrey Cheng, MD, PhD

CONTACT

415 575 0524 rashes@ucsf.edu

Data from ClinicalTrials.gov

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