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

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 - Liberty-AD-HAFT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200441

Enrollment

Registered

2021-03-25

Start date

2021-06-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-Severe Atopic Hand and Foot Dermatitis

Interventions

Drug: Dupilumab Solution for subcutaneous (SC) injection administration Other Names: DUPIXENT, REGN668, SAR231893 Drug: Placebo Solution for SC injection administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline - Patients with involvement of at least 2 anatomical areas at screening and baseline - Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s) - Patients meet the diagnosis criteria for atopic dermatitis (AD) - Provide informed consent/assent signed by study patient or legally acceptable representative - Patients need to have been compliant with the skin protection measures through the entire duration of the screening period

Exclusion criteria

Exclusion criteria: - Treatment with dupilumab in the past - Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis - Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis - Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline - Known history of HIV/HBV/HCV infection - Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study - Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving an IGA (hand and foot) score of 0 or 1 at week 16	—

Countries

Germany, Japan, Poland, United States

Contacts

Public ContactChikako Rosario

Parexel International

Clinicaltrial-registration@parexel.com+81-80-8929-3137

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026