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)

Phase 3

Completed

Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis

Interventions: Drug: Placebo
Drug: dupilumab

Registration Number: NCT04417894

Lead Sponsor: Regeneron Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 133

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo	Placebo	Administered SC Q2W, following a loading dose on Day 1
dupilumab	dupilumab	Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16	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 Outcome Measures

Name	Time	Method
Trough Concentration of Functional Dupilumab in Serum at Various Time Points	Up to week 28
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16	Through week 16
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)	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	Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
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	Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS	Baseline to week 16	Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16	Baseline to Week 16	mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS	Baseline to week 16	Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS	Baseline to week 16	Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
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	Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
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	Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis	Baseline to week 16	For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).
Percentage of Participants With HECSI-75 at Week 16	At week 16	HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.
Percentage of Participants With HECSI-90 at Week 16	At week 16	HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.
Percentage of Participants With HECSI-50 at Week 16	At week 16	HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)	Baseline to week 16	For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).
Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)	Baseline to week 16	WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category	Up to Week 28