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)
NCT ID: NCT04417894
Last Updated: 2023-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
133 participants
INTERVENTIONAL
2021-04-14
2022-11-23
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dupilumab
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
dupilumab
Solution for subcutaneous (SC) injection administration
Matching Placebo
Administered SC Q2W, following a loading dose on Day 1
Placebo
Solution for SC injection administration
Interventions
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dupilumab
Solution for subcutaneous (SC) injection administration
Placebo
Solution for SC injection administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Study Site
Birmingham, Alabama, United States
Regeneron Study Site
Redwood City, California, United States
Regeneron Study Site
Washington D.C., District of Columbia, United States
Regeneron Study Site
Macon, Georgia, United States
Regeneron Study Site
Sandy Springs, Georgia, United States
Regeneron Study Site
Columbus, Indiana, United States
Regeneron Study Site
Rockville, Maryland, United States
Regeneron Study Site
Saint Joseph, Missouri, United States
Regeneron Study Site
St Louis, Missouri, United States
Regeneron Study Site
Kew Gardens, New York, United States
Regeneron Study Site
Mineola, New York, United States
Regeneron Study Site
Winston-Salem, North Carolina, United States
Regeneron Study Site
Portland, Oregon, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Norfolk, Virginia, United States
Regeneron Study Site
Morgantown, West Virginia, United States
Regeneron Study Site
Milwaukee, Wisconsin, United States
Regeneron Study Site
Langenau, Baden-Wurttemberg, Germany
Regeneron Study Site
Frankfurt am Main, Hesse, Germany
Regeneron Study Site
Augsburg, , Germany
Regeneron Study Site
Berlin, , Germany
Regeneron Study Site
Berlin, , Germany
Regeneron Study Site
Bonn, , Germany
Regeneron Study Site
Dresden, , Germany
Regeneron Study Site
Gera, , Germany
Regeneron Study Site
Kiel, , Germany
Regeneron Study Site
Lübeck, , Germany
Regeneron Study Site
Mahlow, , Germany
Regeneron Study Site
Münster, , Germany
Regeneron Study Site
Kawasaki, Kanagawa, Japan
Regeneron Study Site
Sakai, Osaka, Japan
Regeneron Study Site
Shinjuku, Tokyo, Japan
Regeneron Study Site
Tachikawa, Tokyo, Japan
Regeneron Study Site
Kyoto, , Japan
Regeneron Study Site
Osaka, , Japan
Regeneron Study Site
Tokyo, , Japan
Regeneron Study Site
Tokyo, , Japan
Regeneron Study Site
Bialystok, , Poland
Regeneron Study Site
Chorzów, , Poland
Regeneron Study Site
Katowice, , Poland
Regeneron Study Site
Katowice, , Poland
Regeneron Study Site
Kielce, , Poland
Regeneron Study Site
Ostrowiec Świętokrzyski, , Poland
Regeneron Study Site
Warsaw, , Poland
Regeneron Study Site
Warsaw, , Poland
Regeneron Study Site
Warsaw, , Poland
Regeneron Study Site
Wroclaw, , Poland
Regeneron Study Site
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003088-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R668-AD-1924
Identifier Type: -
Identifier Source: org_study_id