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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2023-12-22

Study results available
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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

DRUG

dupilumab

Solution for subcutaneous (SC) injection administration

DRUG

Placebo

Solution for SC injection administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-08-31
Completion
2022-11-23
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Japan
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04417894 on ClinicalTrials.gov