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)

December 1, 2023 updated by: Regeneron Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86179
        • Regeneron Study Site
      • Berlin, Germany, 10117
        • Regeneron Study Site
      • Berlin, Germany, 10789
        • Regeneron Study Site
      • Bonn, Germany, 53127
        • Regeneron Study Site
      • Dresden, Germany, 01307
        • Regeneron Study Site
      • Gera, Germany, 07548
        • Regeneron Study Site
      • Kiel, Germany, 24105
        • Regeneron Study Site
      • Luebeck, Germany, 23538
        • Regeneron Study Site
      • Mahlow, Germany, 15831
        • Regeneron Study Site
      • Muenster, Germany, 48149
        • Regeneron Study Site
    • Baden Wurttemberg
      • Langenau, Baden Wurttemberg, Germany, 89129
        • Regeneron Study Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Regeneron Study Site
  • Japan
      • Kyoto, Japan, 602-8566
        • Regeneron Study Site
      • Osaka, Japan, 532-0003
        • Regeneron Study Site
      • Tokyo, Japan, 105-0012
        • Regeneron Study Site
      • Tokyo, Japan, 143-0023
        • Regeneron Study Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-0063
        • Regeneron Study Site
    • Osaka
      • Sakai, Osaka, Japan, 593-8324
        • Regeneron Study Site
    • Tokyo
      • Shinjuku, Tokyo, Japan, 169-0075
        • Regeneron Study Site
      • Tachikawa, Tokyo, Japan, 190-0023
        • Regeneron Study Site
  • Poland
      • Bialystok, Poland, 15-453
        • Regeneron Study Site
      • Chorzow, Poland, 41-516
        • Regeneron Study Site
      • Katowice, Poland, 40-648
        • Regeneron Study Site
      • Katowice, Poland, 40-851
        • Regeneron Study Site
      • Kielce, Poland, 25-155
        • Regeneron Study Site
      • Ostrowiec Swietokrzyski, Poland, 27-400
        • Regeneron Study Site
      • Warszawa, Poland, 01-142
        • Regeneron Study Site
      • Warszawa, Poland, 02-692
        • Regeneron Study Site
      • Warszawa, Poland, 02-953
        • Regeneron Study Site
      • Wroclaw, Poland, 50-381
        • Regeneron Study Site
      • Wroclaw, Poland, 51-318
        • Regeneron Study Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Regeneron Study Site
    • California
      • Redwood City, California, United States, 94063
        • Regeneron Study Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Regeneron Study Site
    • Georgia
      • Macon, Georgia, United States, 31217
        • Regeneron Study Site
      • Sandy Springs, Georgia, United States, 30328
        • Regeneron Study Site
    • Indiana
      • Columbus, Indiana, United States, 47201
        • Regeneron Study Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Regeneron Study Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Regeneron Study Site
      • Saint Louis, Missouri, United States, 63104
        • Regeneron Study Site
    • New York
      • Kew Gardens, New York, United States, 11415
        • Regeneron Study Site
      • Mineola, New York, United States, 11501
        • Regeneron Study Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Regeneron Study Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Regeneron Study Site
    • Texas
      • Houston, Texas, United States, 77004
        • Regeneron Study Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Regeneron Study Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Regeneron Study Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Regeneron Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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

Key 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

NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: dupilumab
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
Drug: dupilumab
Solution for subcutaneous (SC) injection administration
Other Names:
  • REGN668
  • SAR231893
  • DUPIXENT®
Experimental: Matching Placebo
Administered SC Q2W, following a loading dose on Day 1
Drug: Placebo
Solution for SC injection administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to week 16
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
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
Time Frame: Baseline to week 16
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Baseline to week 16
Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Time Frame: Baseline to week 16
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Baseline to week 16
Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
Time Frame: Baseline to Week 16
mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Baseline to Week 16
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
Time Frame: Baseline to week 16
Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
Baseline to week 16
Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
Time Frame: Baseline to week 16
Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Baseline to week 16
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
Time Frame: Baseline to week 16
Baseline to week 16
Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Time Frame: Baseline to week 4
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Baseline to week 4
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4
Time Frame: Baseline to week 4
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Baseline to week 4
Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis
Time Frame: Baseline to week 16
For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).
Baseline to week 16
Percentage of Participants With HECSI-75 at Week 16
Time Frame: At week 16
HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.
At week 16
Percentage of Participants With HECSI-50 at Week 16
Time Frame: At week 16
HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.
At week 16
Percentage of Participants With HECSI-90 at Week 16
Time Frame: At week 16
HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.
At week 16
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
Time Frame: Baseline to week 16
For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).
Baseline to week 16
Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
Time Frame: Baseline to week 16
WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.
Baseline to week 16
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
Time Frame: Through week 16
Through week 16
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Time Frame: Up to week 28
Up to week 28
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Time Frame: Up to week 28
Up to week 28
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Time Frame: Up to Week 28
Up to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R668-AD-1924
  • 2019-003088-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing 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.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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