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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)

Primary Purpose

Moderate to Severe Atopic Hand and Foot Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dupilumab
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Atopic Hand and Foot Dermatitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dupilumab

Matching Placebo

Arm Description

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

Administered SC Q2W, following a loading dose on Day 1

Outcomes

Primary Outcome Measures

Proportion of patients achieving an Investigator Global Assessment (IGA) (hand and foot) score of 0 or 1
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.

Secondary Outcome Measures

Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (NRS) ≥4
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).
Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3
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).
Percent change in weekly average of daily hand and foot peak Pruritus NRS
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).
Percent change in Modified Total Lesion Sign Score (mTLSS) for hand/foot lesions
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).
Percent change in weekly average of daily hand and foot peak Pain NRS
Pain NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients 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).
Percent change in weekly average of daily Sleep NRS
Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Change in percent surface area of hand and foot involvement with AD
Percent change in weekly average of daily hand and foot peak Pruritus NRS
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).
Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4
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).
Percent change in Hand Eczema Severity Index (HECSI) score
For patients 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).
Proportion of patients with HECSI-75
For patients with hand dermatitis HECSI-75 is defined as HECSI score has ≥75% improvement from baseline.
Proportion of patients with HECSI-50
For patients with hand dermatitis HECSI-50 is defined as HECSI score has ≥50% improvement from baseline.
Proportion of patients with HECSI-90
For patients with hand dermatitis HECSI-90 is defined as HECSI score has ≥90% improvement from baseline.
Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
For patients with hand dermatitis QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.
Change in Work Productivity and Impairment (WPAI) + Classroom Impairment Questionnaire (CIQ)
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.
Incidence of treatment-emergent adverse events (TEAEs)
Trough concentration of functional dupilumab in serum
Incidence of treatment-emergent anti-drug antibody (ADA) and titer

Full Information

First Posted
June 2, 2020
Last Updated
January 12, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04417894
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Atopic Hand and Foot Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dupilumab
Arm Type
Experimental
Arm Description
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
Arm Title
Matching Placebo
Arm Type
Experimental
Arm Description
Administered SC Q2W, following a loading dose on Day 1
Intervention Type
Drug
Intervention Name(s)
dupilumab
Other Intervention Name(s)
DUPIXENT®, REGN668, SAR231893
Intervention Description
Solution for subcutaneous (SC) injection administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for SC injection administration
Primary Outcome Measure Information:
Title
Proportion of patients achieving an Investigator Global Assessment (IGA) (hand and foot) score of 0 or 1
Description
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.
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (NRS) ≥4
Description
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).
Time Frame
Baseline to week 16
Title
Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3
Description
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).
Time Frame
Baseline to week 16
Title
Percent change in weekly average of daily hand and foot peak Pruritus NRS
Description
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).
Time Frame
Baseline to week 16
Title
Percent change in Modified Total Lesion Sign Score (mTLSS) for hand/foot lesions
Description
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).
Time Frame
Baseline to week 16
Title
Percent change in weekly average of daily hand and foot peak Pain NRS
Description
Pain NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients 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).
Time Frame
Baseline to week 16
Title
Percent change in weekly average of daily Sleep NRS
Description
Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Time Frame
Baseline to week 16
Title
Change in percent surface area of hand and foot involvement with AD
Time Frame
Baseline to week 16
Title
Percent change in weekly average of daily hand and foot peak Pruritus NRS
Description
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).
Time Frame
Baseline to week 4
Title
Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4
Description
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).
Time Frame
Baseline to week 4
Title
Percent change in Hand Eczema Severity Index (HECSI) score
Description
For patients 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).
Time Frame
Baseline to week 16
Title
Proportion of patients with HECSI-75
Description
For patients with hand dermatitis HECSI-75 is defined as HECSI score has ≥75% improvement from baseline.
Time Frame
At week 16
Title
Proportion of patients with HECSI-50
Description
For patients with hand dermatitis HECSI-50 is defined as HECSI score has ≥50% improvement from baseline.
Time Frame
At week 16
Title
Proportion of patients with HECSI-90
Description
For patients with hand dermatitis HECSI-90 is defined as HECSI score has ≥90% improvement from baseline.
Time Frame
At week 16
Title
Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
Description
For patients with hand dermatitis QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.
Time Frame
Baseline to week 16
Title
Change in Work Productivity and Impairment (WPAI) + Classroom Impairment Questionnaire (CIQ)
Description
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.
Time Frame
Baseline to week 16
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
Through week 16
Title
Trough concentration of functional dupilumab in serum
Time Frame
Up to week 28
Title
Incidence of treatment-emergent anti-drug antibody (ADA) and titer
Time Frame
Up to week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Regeneron Study Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Regeneron Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Regeneron Study Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Regeneron Study Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Regeneron Study Site
City
Columbus
State/Province
Indiana
ZIP/Postal Code
47201
Country
United States
Facility Name
Regeneron Study Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Regeneron Study Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Regeneron Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Regeneron Study Site
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Regeneron Study Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Regeneron Study Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Regeneron Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Regeneron Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Regeneron Study Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Regeneron Study Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Regeneron Study Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Regeneron Study Site
City
Langenau
State/Province
Baden Wurttemberg
ZIP/Postal Code
89129
Country
Germany
Facility Name
Regeneron Study Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Regeneron Study Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Regeneron Study Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Regeneron Study Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Regeneron Study Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Regeneron Study Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Regeneron Study Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Regeneron Study Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Regeneron Study Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Regeneron Study Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Regeneron Study Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Regeneron Study Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
Regeneron Study Site
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Regeneron Study Site
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
169-0075
Country
Japan
Facility Name
Regeneron Study Site
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0023
Country
Japan
Facility Name
Regeneron Study Site
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Regeneron Study Site
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Regeneron Study Site
City
Tokyo
ZIP/Postal Code
105-0012
Country
Japan
Facility Name
Regeneron Study Site
City
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Regeneron Study Site
City
Bialystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Regeneron Study Site
City
Chorzow
ZIP/Postal Code
41-516
Country
Poland
Facility Name
Regeneron Study Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Regeneron Study Site
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
Regeneron Study Site
City
Kielce
ZIP/Postal Code
25-155
Country
Poland
Facility Name
Regeneron Study Site
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Regeneron Study Site
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Regeneron Study Site
City
Warszawa
ZIP/Postal Code
02-692
Country
Poland
Facility Name
Regeneron Study Site
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Regeneron Study Site
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Regeneron Study Site
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/

Learn more about this trial

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)

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