E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10012438 |
E.1.2 | Term | Dermatitis atopic |
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 evaluate the effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD) |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation
To continue to access the safety and tolerability throughout the study
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants, male or female 18 years or older,
- with diagnosed chronic atopic dermatitis (AD), demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance
- having applied skin emolients (moisturizers) at least 7 days before randomization
- having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before randomization
- willing and able to comply with all clinic visits and study-related procedures
- providing signed informed consent |
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E.4 | Principal exclusion criteria |
Participants excluded from the study:
- with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that may present unreasonable risk to patients or interfere with study assessment, or any severe concomitant illness(es) that would adversely affect the patient's participation in the study, and contraindications of topical coricosteroids
- at baseline, presence of any conditions listed as criteria for study drug discontinuation
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change from baseline to Week 12 in sleep quality numerical rating scale (NRS) : Percentage change from baseline to Week 12 in sleep quality. Sleep quality is measured daily using a numerical rating scale; weekly average is used for the analysis |
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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 : Change from baseline to Week 12 in sleep efficiency based on actigraphy data : Absolute change from baseline to Week 12 in sleep efficiency based on actigraph data. Sleep Efficiency is calculated as the proportion of time spent asleep vs total time in bed, expressed as a percentage. This is assessed daily and weekly average is used in the analysis
2 : Change from baseline to Week 12 in total sleep time based on actigraphy data : Absolute change from baseline to Week 12 in total sleep time based on actigraph data. Total sleep time is assessed daily; Weekly average is used in the analysis
3 : Change from baseline to Week 12 in wake after sleep onset based on actigraph data : Absolute change from baseline to Week 12 in wake after sleep onset (WASO) based on actigraph data. WASO is assessed daily; Weekly average is used in the analysis
4 : Change from baseline to Week 12 in sleep latency based on actigraph data : Absolute change from baseline to Week 12 in sleep latency based on actigraph data. Sleep latency is assessed daily; weekly average is used in the analysis
5 : Percent change from baseline to Week 12 in pruritus : Percentage change from baseline to Week 12 in pruritus. Pruritus is measured daily using a numerical rating scale; weekly average is used for the analysis
6 : Change from baseline to Week 12 in SCORing Atopic Dermatitis (SCORAD) total score : Absolute change from baseline to Week 12 in SCORAD total score
7 : Change from baseline to Week 12 in SCORAD sleep Visual Analog Scale (VAS) subscore : Absolute change from baseline to Week 12 in SCORAD sleep VAS subscore
8 : Change from baseline to Week 12 in Patient Oriented Eczema Measure (POEM) total score : Absolute change from baseline to Week 12 in POEM total score
9 : EASI50 (50% reduction in Eczema Area and Severity Index score) at Week 12 : Proportion of patients with EASI50 (reduction of EASI score by ≥50% from baseline) at Week 12
10 : EASI75 (75% reduction in Eczema Area and Severity Index score) at Week12 : Proportion of patients with EASI75 (reduction of EASI score by ≥75% from baseline) at Week 12
11 : Change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score : Absolute change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score
12 : Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment SF8a Total Score : Absolute change from baseline to Week 12 in PROMIS Sleep Related Impairment SF8a Total Score
13 : Adverse events through Week 24 : Incidence of adverse events reported |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 : Baseline to Week 12
13 : From the signing of Informed consent to resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
12 weeks Double-Blind, followed by 12 weeks Open-Label |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Australia |
France |
Germany |
Israel |
Italy |
Spain |
Switzerland |
United Arab Emirates |
United Kingdom |
United States |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |