Molecular Signatures of Cutaneous Dupilumab Response

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05858619
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Dupilumab	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Molecular Signatures of Cutaneous Dupilumab Response
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2026
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dupilumab treatment Treatment with IL4RA inhibitor	Drug: Dupilumab; dupilumab

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Jeffrey Cheng, MD, PhD, University of California, San Francisco
• Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05858619
• Other Study ID Numbers: 21-35748
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dermatitis

Study Results

No Results Posted as of May 15, 2023