E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic hand and foot dermatitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012431 |
E.1.2 | Term | Dermatitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. |
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E.2.2 | Secondary objectives of the trial |
-To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment, mental health) 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
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Optional genomics sub-study |
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E.3 | Principal inclusion criteria |
1. Male or female ≥12 years old at screening
2. Patients need to have an overall IGA hand and foot score of 3 or 4 at screening and baseline.
3. 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)
4. Patients meet the diagnosis criteria for atopic dermatitis (AD)
5. Provide informed consent/assent signed by study patient or legally acceptable representative.
6. Patients need to have been compliant with the skin protection measures through the entire duration of the screening period
NOTE: Other protocol defined inclusion criteria apply |
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E.4 | Principal exclusion criteria |
1. Treatment with dupilumab in the past.
2. Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and/or foot dermatitis
3. Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis
4. Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs such as cyclosporine within 4 weeks prior to baseline
5. Known history of HIV/HBV/HCV infection
6. Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient’s participation in this study.
7. 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 exclusion criteria apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving an Investigator Global Assessment (hand and foot) score of 0 or 1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4
2. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3
3. Percent change in weekly average of daily hand and foot peak Pruritus NRS
4. Percent change in mTLSS for hand/foot lesions from baseline to week 16
5. Percent change in weekly average of daily hand and foot peak
Pain NRS
6. Percent change in weekly average of daily Sleep NRS
7. Change in percent surface area of hand and foot involvement with AD
8. Percent change in weekly average of daily hand and foot peak Pruritus NRS
9. Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4
10. For patients with hand dermatitis, percent change in Hand Eczema Severity Index (HECSI) score
11. For patients with hand dermatitis, proportion of patients with HECSI-75
12. For patients with hand dermatitis, proportion of patients with HECSI-50
13. For patients with hand dermatitis, proportion of patients with HECSI-90
14. For patients with hand dermatitis, change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
15. Change in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
16. Incidence of treatment-emergent adverse events (TEAEs)
17. Trough concentration of functional dupilumab in serum at various time points
18. Incidence of treatment-emergent anti-drug antibody (ADA) and titer over time
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(1 - 7, 10, 14, 15) Baseline to week 16
(8-9) Baseline to week 4
(11-13) At week 16
(16) Through week 16
(17-18) Up to week 28
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Japan |
United States |
Germany |
Poland |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |