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)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis

Treatments: Drug: dupilumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04417894

2019-003088-22 (EudraCT Number)

R668-AD-1924

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups

dupilumab

Experimental group

Description:

Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

Treatment:

Drug: dupilumab

Matching Placebo

Experimental group

Description:

Administered SC Q2W, following a loading dose on Day 1

Treatment:

Drug: Placebo