NCT04823130

Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis

A Multi-center, Exploratory Study to Assess Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: \- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus. Secondary Objectives: * Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in skin biopsies from AD participants with chronic pruritus. * To evaluate the efficacy of dupilumab in AD participants with chronic pruritus. * To evaluate the safety of dupilumab in adult participants with moderate-to-severe AD.

Detailed description

AD participants: A 20-week Observation Period including 16 weeks of treatment for AD participants and a 4-week follow-up period; Healthy participants: 8 days observation period.

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab (SAR231893)	Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-06-30
• Completion: 2022-08-30
• First posted: 2021-03-30
• Last updated: 2025-09-16
• Results posted: 2023-07-11

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study