Clinical trial NCT04417894: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2020-06-05
Enrollment: 133
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
timeFrame: At week 16
Secondary outcomes:
measure: Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16
timeFrame: Baseline to week 16
measure: Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16
timeFrame: Baseline to week 16
measure: Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
timeFrame: Baseline to week 16
measure: Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
timeFrame: Baseline to week 16
measure: Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
timeFrame: Baseline to week 16
measure: Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
timeFrame: Baseline to week 16
measure: Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
timeFrame: Baseline to week 4
measure: Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4
timeFrame: Baseline to week 4
measure: Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis
timeFrame: Baseline to week 16
measure: Percentage of Participants With HECSI-75 at Week 16
timeFrame: At week 16
measure: Percentage of Participants With HECSI-50 at Week 16
timeFrame: At week 16
measure: Percentage of Participants With HECSI-90 at Week 16
timeFrame: At week 16
measure: Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
timeFrame: Baseline to week 16
measure: Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
timeFrame: Baseline to week 16
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
timeFrame: Through week 16
measure: Trough Concentration of Functional Dupilumab in Serum at Various Time Points
timeFrame: Up to week 28
measure: Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
timeFrame: Up to week 28
measure: Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
timeFrame: Up to Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Study Site
state: Alabama
city: Redwood City
country: United States
facility: Regeneron Study Site
state: California
city: Washington
country: United States
facility: Regeneron Study Site
state: District of Columbia
city: Macon
country: United States
facility: Regeneron Study Site
state: Georgia
city: Sandy Springs
country: United States
facility: Regeneron Study Site
state: Georgia
city: Columbus
country: United States
facility: Regeneron Study Site
state: Indiana
city: Rockville
country: United States
facility: Regeneron Study Site
state: Maryland
city: Saint Joseph
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Kew Gardens
country: United States
facility: Regeneron Study Site
state: New York
city: Mineola
country: United States
facility: Regeneron Study Site
state: New York
city: Winston-Salem
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Norfolk
country: United States
facility: Regeneron Study Site
state: Virginia
city: Morgantown
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Milwaukee
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Langenau
country: Germany
facility: Regeneron Study Site
state: Baden Wurttemberg
city: Frankfurt
country: Germany
facility: Regeneron Study Site
state: Hessen
city: Augsburg
country: Germany
facility: Regeneron Study Site
city: Berlin
country: Germany
facility: Regeneron Study Site
city: Berlin
country: Germany
facility: Regeneron Study Site
city: Bonn
country: Germany
facility: Regeneron Study Site
city: Dresden
country: Germany
facility: Regeneron Study Site
city: Gera
country: Germany
facility: Regeneron Study Site
city: Kiel
country: Germany
facility: Regeneron Study Site
city: Luebeck
country: Germany
facility: Regeneron Study Site
city: Mahlow
country: Germany
facility: Regeneron Study Site
city: Muenster
country: Germany
facility: Regeneron Study Site
city: Kawasaki
country: Japan
facility: Regeneron Study Site
state: Kanagawa
city: Sakai
country: Japan
facility: Regeneron Study Site
state: Osaka
city: Shinjuku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Kyoto
country: Japan
facility: Regeneron Study Site
city: Osaka
country: Japan
facility: Regeneron Study Site
city: Tokyo
country: Japan
facility: Regeneron Study Site
city: Tokyo
country: Japan
facility: Regeneron Study Site
city: Bialystok
country: Poland
facility: Regeneron Study Site
city: Chorzow
country: Poland
facility: Regeneron Study Site
city: Katowice
country: Poland
facility: Regeneron Study Site
city: Katowice
country: Poland
facility: Regeneron Study Site
city: Kielce
country: Poland
facility: Regeneron Study Site
city: Ostrowiec Swietokrzyski
country: Poland
facility: Regeneron Study Site
city: Warszawa
country: Poland
facility: Regeneron Study Site
city: Warszawa
country: Poland
facility: Regeneron Study Site
city: Warszawa
country: Poland
facility: Regeneron Study Site
city: Wroclaw
country: Poland
facility: Regeneron Study Site
city: Wroclaw
country: Poland
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: