Phase 3
N=133
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)
Moderate to Severe Atopic Hand and Foot Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04417894 ↗Enrolled (actual)
133
Serious AEs
3.0%
Results posted
Dec 2023
Primary outcome: Primary: Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 — 16.7; 40.3 Percentage of participants — p==0.0030
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dupilumab (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 |
16.7; 40.3 | =0.0030 sig |
| SECONDARY 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 |
13.6; 52.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16 |
16.7; 61.2 | — |
| SECONDARY Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS |
-26.2; -62.9 | — |
| SECONDARY Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 |
-31.0; -69.4 | — |
| SECONDARY Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS |
-1.93; -4.66 | — |
| SECONDARY Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS |
-0.00; 0.88 | — |
| SECONDARY Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) |
-10.01; -16.70 | — |
| SECONDARY Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS |
-25.6; -47.2 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4 |
9.1; 34.3 | — |
| SECONDARY Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis |
-33.8; -68.2 | — |
| SECONDARY Percentage of Participants With HECSI-75 at Week 16 |
21.5; 46.9 | — |
| SECONDARY Percentage of Participants With HECSI-50 at Week 16 |
30.8; 75.0 | — |
| SECONDARY Percentage of Participants With HECSI-90 at Week 16 |
9.2; 18.8 | — |
| SECONDARY Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) |
-13.36; -38.70 | — |
| SECONDARY Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) |
-21.26; -36.39 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 |
74.2; 65.7 | — |
| SECONDARY Trough Concentration of Functional Dupilumab in Serum at Various Time Points |
0; 0; 0; 51.2; 34.0; 37.1 | — |
| SECONDARY Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) |
0; 0; 1; 8 | — |
| SECONDARY Number of Participants With Treatment-Emergent ADA by Maximum Titer Category |
1; 8; 0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04417894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.