NCT05680298

Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and \<12 years old), and a 12-week follow-up period. Patients will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 End of Treatment (EoT) phase visit, and every 6-weeks thereafter during the follow-up period and by this will end the study for each participant (End of Study \[EoS\]). The maximum duration of the study per participant will be 32 weeks (including screening period). Skin barrier function in approximately 10 healthy volunteers (not more than 20 healthy participants aged ≥6 and \<12 years old) matched for age (match on age ±2 years), gender, location of targeted lesion area, and study site to the AD cases will be assessed in a similar manner at baseline, and will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 EoT phase visit, and every 6-weeks thereafter during the follow-up period, serving as a reference comparator for skin barrier function.

Detailed description

32 weeks

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	solution for injection, Subcutaneous injection

Timeline

• Start date: 2023-02-22
• Primary completion: 2023-12-22
• Completion: 2024-03-15
• First posted: 2023-01-11
• Last updated: 2025-02-10

Locations

1 site across 1 country: China