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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)

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ClinicalTrials.gov Identifier: NCT04417894
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : May 20, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Moderate to Severe Atopic Hand and Foot Dermatitis Drug: dupilumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : November 17, 2022
Estimated Study Completion Date : May 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
Drug Information available for: Dupilumab

Arm Intervention/treatment
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:
  • DUPIXENT®
  • REGN668
  • SAR231893

Experimental: Matching Placebo
Administered SC Q2W, following a loading dose on Day 1
Drug: Placebo
Solution for SC injection administration




Primary Outcome Measures :
  1. Proportion of patients achieving an Investigator Global Assessment (IGA) (hand and foot) score of 0 or 1 [ 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.


Secondary Outcome Measures :
  1. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (NRS) ≥4 [ 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).

  2. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3 [ 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).

  3. Percent change 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).

  4. Percent change in Modified Total Lesion Sign Score (mTLSS) for hand/foot lesions [ 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).

  5. Percent change 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 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).

  6. Percent change 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.

  7. Change in percent surface area of hand and foot involvement with AD [ Time Frame: Baseline to week 16 ]
  8. Percent change 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 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).

  9. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 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).

  10. Percent change in Hand Eczema Severity Index (HECSI) score [ Time Frame: Baseline to week 16 ]

    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).


  11. Proportion of patients with HECSI-75 [ Time Frame: At week 16 ]

    For patients with hand dermatitis

    HECSI-75 is defined as HECSI score has ≥75% improvement from baseline.


  12. Proportion of patients with HECSI-50 [ Time Frame: At week 16 ]

    For patients with hand dermatitis

    HECSI-50 is defined as HECSI score has ≥50% improvement from baseline.


  13. Proportion of patients with HECSI-90 [ Time Frame: At week 16 ]

    For patients with hand dermatitis

    HECSI-90 is defined as HECSI score has ≥90% improvement from baseline.


  14. Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [ Time Frame: Baseline to week 16 ]

    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.


  15. Change in Work Productivity and Impairment (WPAI) + 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.

  16. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through week 16 ]
  17. Trough concentration of functional dupilumab in serum [ Time Frame: Up to week 28 ]
  18. Incidence of treatment-emergent anti-drug antibody (ADA) and titer [ Time Frame: Up to week 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417894


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Maryland
Regeneron Study Site Recruiting
Rockville, Maryland, United States, 20850
United States, Missouri
Regeneron Study Site Recruiting
Saint Joseph, Missouri, United States, 64506
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04417894    
Other Study ID Numbers: R668-AD-1924
2019-003088-22 ( EudraCT Number )
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Skin Diseases