Molecular Signatures of Cutaneous Dupilumab Response

Phase 4

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Dupilumab

• Registration Number: NCT05858619
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dupilumab treatment	Dupilumab	Treatment with IL4RA inhibitor

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States