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Molecular Signatures of Cutaneous Dupilumab Response

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dupilumab treatment

Arm Description

Treatment with IL4RA inhibitor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05858619
Brief Title
Molecular Signatures of Cutaneous Dupilumab Response
Official Title
Molecular Signatures of Cutaneous Dupilumab Response
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dupilumab treatment
Arm Type
Experimental
Arm Description
Treatment with IL4RA inhibitor
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
dupilumab
Primary Outcome Measure Information:
Title
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Cheng, MD, PhD
Phone
415 575 0524
Email
rashes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cheng, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cheng, MD, PhD
Email
rashes@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Molecular Signatures of Cutaneous Dupilumab Response

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