Molecular Signatures of Cutaneous Dupilumab Response

NCT ID: NCT05858619

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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dupilumab treatment

Treatment with IL4RA inhibitor

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

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

Interventions

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Dupilumab

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

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Raymond Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey Cheng, MD, PhD

Role: CONTACT

415 575 0524

Facility Contacts

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Jeffrey Cheng, MD, PhD

Role: primary

Other Identifiers

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21-35748

Identifier Type: -

Identifier Source: org_study_id

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