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 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: R668-AD-19242019-003088-22
• Study Type: interventional
• Target: 133
• Locations: 4 countries
• Sites: 48

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16

  IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.

  At week 16

Secondary Outcomes (19)

• Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16

  Baseline to week 16

• Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16

  Baseline to week 16

• Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS

  Baseline to week 16

• Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16

  Baseline to Week 16

• Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS

  Baseline to week 16

Study Arms (2)

dupilumab

EXPERIMENTAL

Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

Drug: dupilumab

Matching Placebo

EXPERIMENTAL

Administered SC Q2W, following a loading dose on Day 1

Drug: Placebo

Interventions

dupilumab DRUG

Solution for subcutaneous (SC) injection administration

Also known as: DUPIXENT®, REGN668, SAR231893

dupilumab

Placebo DRUG

Solution for SC injection administration

Matching Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with involvement of at least 2 anatomical areas at screening and baseline
• Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (48)

Regeneron Study Site

Birmingham, Alabama, 35209, United States

Location

Regeneron Study Site

Redwood City, California, 94063, United States

Location

Regeneron Study Site

Washington D.C., District of Columbia, 20037, United States

Location

Regeneron Study Site

Macon, Georgia, 31217, United States

Location

Regeneron Study Site

Sandy Springs, Georgia, 30328, United States

Location

Regeneron Study Site

Columbus, Indiana, 47201, United States

Location

Regeneron Study Site

Rockville, Maryland, 20850, United States

Location

Regeneron Study Site

Saint Joseph, Missouri, 64506, United States

Location

Regeneron Study Site

St Louis, Missouri, 63104, United States

Location

Regeneron Study Site

Kew Gardens, New York, 11415, United States

Location

Regeneron Study Site

Mineola, New York, 11501, United States

Location

Regeneron Study Site

Winston-Salem, North Carolina, 27157, United States

Location

Regeneron Study Site

Portland, Oregon, 97239, United States

Location

Regeneron Study Site

Houston, Texas, 77004, United States

Location

Regeneron Study Site

Norfolk, Virginia, 23502, United States

Location

Regeneron Study Site

Morgantown, West Virginia, 26505, United States

Location

Regeneron Study Site

Milwaukee, Wisconsin, 53226, United States

Location

Regeneron Study Site

Langenau, Baden-Wurttemberg, 89129, Germany

Location

Regeneron Study Site

Frankfurt am Main, Hesse, 60590, Germany

Location

Regeneron Study Site

Augsburg, 86179, Germany

Location

Regeneron Study Site

Berlin, 10117, Germany

Location

Regeneron Study Site

Berlin, 10789, Germany

Location

Regeneron Study Site

Bonn, 53127, Germany

Location

Regeneron Study Site

Dresden, 01307, Germany

Location

Regeneron Study Site

Gera, 07548, Germany

Location

Regeneron Study Site

Kiel, 24105, Germany

Location

Regeneron Study Site

Lübeck, 23538, Germany

Location

Regeneron Study Site

Mahlow, 15831, Germany

Location

Regeneron Study Site

Münster, 48149, Germany

Location

Regeneron Study Site

Kawasaki, Kanagawa, 211-0063, Japan

Location

Regeneron Study Site

Sakai, Osaka, 593-8324, Japan

Location

Regeneron Study Site

Shinjuku, Tokyo, 169-0075, Japan

Location

Regeneron Study Site

Tachikawa, Tokyo, 190-0023, Japan

Location

Regeneron Study Site

Kyoto, 602-8566, Japan

Location

Regeneron Study Site

Osaka, 532-0003, Japan

Location

Regeneron Study Site

Tokyo, 105-0012, Japan

Location

Regeneron Study Site

Tokyo, 143-0023, Japan

Location

Regeneron Study Site

Bialystok, 15-453, Poland

Location

Regeneron Study Site

Chorzów, 41-516, Poland

Location

Regeneron Study Site

Katowice, 40-648, Poland

Location

Regeneron Study Site

Katowice, 40-851, Poland

Location

Regeneron Study Site

Kielce, 25-155, Poland

Location

Regeneron Study Site

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Regeneron Study Site

Warsaw, 01-142, Poland

Location

Regeneron Study Site

Warsaw, 02-692, Poland

Location

Regeneron Study Site

Warsaw, 02-953, Poland

Location

Regeneron Study Site

Wroclaw, 50-381, Poland

Location

Regeneron Study Site

Wroclaw, 51-318, Poland

Location

Related Publications (1)

• 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). 2025 Nov 15. doi: 10.1007/s13555-025-01592-y. Online ahead of print.

  PMID: 41240207 DERIVED

MeSH Terms

Interventions

dupilumab

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: April 14, 2021
• Primary Completion: August 31, 2022
• Study Completion: November 23, 2022
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

US (17); JP (8); DE (12); PL (11)