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)

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

Timeline

Start

2021-04-14

Primary completion

2022-08-31

Completion

2022-11-23

Outcome

Met primary endpoint

registry NUMBER Dupilumab Q2W: 40.3 Percentage of participants NCT04417894 ↗

registry analysis (superiority test); Matching Placebo vs Dupilumab Q2W; p =0.0030; Cochran-Mantel-Haenszel NCT04417894 ↗

release “Dupixent experienced the following: 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo (p≤0.01), the primary endpoint.” regeneron.com ↗

Publications

• Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	—	Subcutaneous

Indications