NCT05624112

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Chinese Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter. A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.

Conditions

• Atopic Dermatitis
• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab	Dupilumab solution in a pre-filled syringe for Subcutaneous injection

Timeline

• Start date: 2022-11-25
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2022-11-21
• Last updated: 2025-09-15

Locations

1 site across 1 country: China