NCT04417894CompletedPhase 3
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
Regeneron Pharmaceuticals1 site in 1 country133 target enrollmentStarted: April 14, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
dupilumab
Experimental
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
Intervention: dupilumab (Drug)
Matching Placebo
Experimental
Administered SC Q2W, following a loading dose on Day 1
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
Time Frame: At week 16
IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.
Secondary Outcomes
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16(Through week 16)
- Trough Concentration of Functional Dupilumab in Serum at Various Time Points(Up to week 28)
- 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(Baseline to week 16)
- Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16(Baseline to week 16)
- Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS(Baseline to week 16)
- Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16(Baseline to Week 16)
- Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS(Baseline to week 16)
- Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS(Baseline to week 16)
- Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)(Baseline to week 16)
- Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS(Baseline to week 4)
- Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4(Baseline to week 4)
- Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis(Baseline to week 16)
- Percentage of Participants With HECSI-75 at Week 16(At week 16)
- Percentage of Participants With HECSI-90 at Week 16(At week 16)
- Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)(Up to week 28)
- Percentage of Participants With HECSI-50 at Week 16(At week 16)
- Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)(Baseline to week 16)
- Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)(Baseline to week 16)
- Number of Participants With Treatment-Emergent ADA by Maximum Titer Category(Up to Week 28)
Investigators
Study Sites (1)
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