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)
Condition: Moderate to Severe Atopic Hand and Foot Dermatitis
MeSH terms: Dermatitis
Intervention: dupilumab; Placebo
Intervention description: Solution for subcutaneous (SC) injection administration; Solution for SC injection administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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