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Trial record 1 of 1 for:    r668-ad-1924
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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

Tracking Information
First Submitted Date  ICMJE June 2, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE April 14, 2021
Estimated Primary Completion Date November 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
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 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • Change in percent surface area of hand and foot involvement with AD [ Time Frame: Baseline to week 16 ]
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through week 16 ]
  • Trough concentration of functional dupilumab in serum [ Time Frame: Up to week 28 ]
  • Incidence of treatment-emergent anti-drug antibody (ADA) and titer [ Time Frame: Up to week 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • 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).
  • Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (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).
  • Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 16 ]
  • Percent change in weekly average of daily hand and foot peak Pruritus NRS [ Time Frame: Baseline to week 16 ]
  • 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).
  • 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.
  • Change in percent surface area of hand and foot involvement with AD [ Time Frame: Baseline to week 16 ]
  • Change in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
    POEM is a 7-item questionnaire that assesses disease symptoms that uses a scoring system of 0 (absent disease) to 28 (severe disease).
  • Change in health-related quality of life as measured by Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 16 ]
    Adults DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
  • Change in health-related quality of life as measured by Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to week 16 ]
    Adolescents CDLQI is DLQI for children
  • Percent change in weekly average of daily hand and foot peak Pruritus NRS [ Time Frame: Baseline to week 4 ]
  • Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 4 ]
  • Change in Hospital Anxiety and Depression scale (HADS) [ Time Frame: Baseline to week 16 ]
    HADS is a 14-item questionnaire, (7)for anxiety and (7) for depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
  • 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).
  • 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.
  • 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.
  • 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.
  • Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [ Time Frame: Baseline to week 16 ]
    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) [ 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.
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through week 16 ]
  • Trough concentration of functional dupilumab in serum [ Time Frame: Up to week 28 ]
  • Incidence of treatment-emergent anti-drug antibody (ADA) and titer [ Time Frame: Up to week 28 ]
  • Change in thymus and activation-regulated chemokine (TARC) levels [ Time Frame: Baseline to week 28 ]
  • Change in lactate dehydrogenase (LDH) levels [ Time Frame: Baseline to week 28 ]
  • Change in total IgE levels [ Time Frame: Baseline to week 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Atopic Hand and Foot Dermatitis
Intervention  ICMJE
  • Drug: dupilumab
    Solution for subcutaneous (SC) injection administration
    Other Names:
    • DUPIXENT®
    • REGN668
    • SAR231893
  • Drug: Placebo
    Solution for SC injection administration
Study Arms  ICMJE
  • Experimental: dupilumab
    Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
    Intervention: Drug: dupilumab
  • Experimental: Matching Placebo
    Administered SC Q2W, following a loading dose on Day 1
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 25, 2023
Estimated Primary Completion Date November 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04417894
Other Study ID Numbers  ICMJE R668-AD-1924
2019-003088-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP