drugset / Trial / 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)

NCT04417894

Phase 3 Completed 133 enrolled Regeneron Pharmaceuticals Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody Subcutaneous

Indications