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)

Last updated: December 1, 2023
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Rash

Allergy

Treatment

Placebo

dupilumab

Clinical Study ID

NCT04417894
R668-AD-1924
2019-003088-22
  • Ages > 12
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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-severedisease) 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 acceptablerepresentative
  • Patients need to have been compliant with the skin protection measures through theentire duration of the screening period

Exclusion

Key Exclusion Criteria:

  • Treatment with dupilumab in the past
  • Patients with a positive patch test reaction that are deemed to be clinically relevantas the current cause of the hand and foot dermatitis
  • Patients with documented exposure to irritants believed to be a predominant cause ofthe current hand and foot dermatitis
  • Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugswithin 4 weeks prior to baseline
  • Known history of HIV/HBV/HCV infection
  • Pregnant or breastfeeding women or planning to become pregnant or breastfeed duringthe patient's participation in this study
  • Women of childbearing potential (WOCBP) who are unwilling to practice highly effectivecontraception prior to the initial dose/start of the first treatment and during thestudy NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Design

Total Participants: 133
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 14, 2021
Estimated Completion Date:
November 23, 2022

Connect with a study center

  • Regeneron Study Site

    Langenau, Baden Wurttemberg 89129
    Germany

    Site Not Available

  • Regeneron Study Site

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Regeneron Study Site

    Augsburg, 86179
    Germany

    Site Not Available

  • Regeneron Study Site

    Berlin, 10117
    Germany

    Site Not Available

  • Regeneron Study Site

    Bonn, 53127
    Germany

    Site Not Available

  • Regeneron Study Site

    Dresden, 01307
    Germany

    Site Not Available

  • Regeneron Study Site

    Gera, 07548
    Germany

    Site Not Available

  • Regeneron Study Site

    Kiel, 24105
    Germany

    Site Not Available

  • Regeneron Study Site

    Luebeck, 23538
    Germany

    Site Not Available

  • Regeneron Study Site

    Mahlow, 15831
    Germany

    Site Not Available

  • Regeneron Study Site

    Muenster, 48149
    Germany

    Site Not Available

  • Regeneron Study Site

    Kawasaki, Kanagawa 211-0063
    Japan

    Site Not Available

  • Regeneron Study Site

    Sakai, Osaka 593-8324
    Japan

    Site Not Available

  • Regeneron Study Site

    Shinjuku, Tokyo 169-0075
    Japan

    Site Not Available

  • Regeneron Study Site

    Tachikawa, Tokyo 190-0023
    Japan

    Site Not Available

  • Regeneron Study Site

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Regeneron Study Site

    Osaka, 532-0003
    Japan

    Site Not Available

  • Regeneron Study Site

    Tokyo, 105-0012
    Japan

    Site Not Available

  • Regeneron Study Site

    Bialystok, 15-453
    Poland

    Site Not Available

  • Regeneron Study Site

    Chorzow, 41-516
    Poland

    Site Not Available

  • Regeneron Study Site

    Katowice, 40-648
    Poland

    Site Not Available

  • Regeneron Study Site

    Kielce, 25-155
    Poland

    Site Not Available

  • Regeneron Study Site

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Regeneron Study Site

    Warszawa, 02-953
    Poland

    Site Not Available

  • Regeneron Study Site

    Wroclaw, 50-381
    Poland

    Site Not Available

  • Regeneron Study Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Regeneron Study Site

    Redwood City, California 94063
    United States

    Site Not Available

  • Regeneron Study Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Regeneron Study Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • Regeneron Study Site

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Regeneron Study Site

    Columbus, Indiana 47201
    United States

    Site Not Available

  • Regeneron Study Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Regeneron Study Site

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Regeneron Study Site

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Regeneron Study Site

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Regeneron Study Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Regeneron Study Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Regeneron Study Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Regeneron Study Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Regeneron Study Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Regeneron Study Site

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • Regeneron Study Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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