NCT04417894

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. The secondary objectives of the study are: * To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis * To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis * To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis

Conditions

• Moderate to Severe Atopic Hand and Foot Dermatitis

Interventions

Type	Name	Description
DRUG	dupilumab	Solution for subcutaneous (SC) injection administration
DRUG	Placebo	Solution for SC injection administration

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-08-31
• Completion: 2022-11-23
• First posted: 2020-06-05
• Last updated: 2023-12-22
• Results posted: 2023-12-22

Locations

48 sites across 4 countries: United States, Germany, Japan, Poland

Regulatory

• FDA-regulated drug study