NCT05858619

Molecular Signatures of Cutaneous Dupilumab Response

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	dupilumab 600 mg injection initially and then 300 mg every other week

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-05-15
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study