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)

Conditions

• Moderate to Severe Atopic Hand and Foot Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• dupilumab — DRUG
  Solution for subcutaneous (SC) injection administration
• Placebo — DRUG
  Solution for SC injection administration

Study Details

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

Key Dates

Start date

Apr 14, 2021

Status verified

Dec 2023

Primary completion

Aug 31, 2022

Completion

Nov 23, 2022

Study Design

Enrollment

133 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: dupilumab
  Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
• Experimental: Matching Placebo
  Administered SC Q2W, following a loading dose on Day 1

Primary Outcome Measure

Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 [ Time Frame: At week 16 ]

Locations (17)

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