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 | 10014184 |
E.1.2 | Term | Eczema |
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 |
The primary objective is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe AD subjects with severe pruritus receiving , Topical Cortico Steroid who were not adequately controlled with topical treatments. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the safety of nemolizumab and to characterize its pharmacokinetic (PK) profile. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects ≥ 18 years (or legal age when higher)
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 2 years before the visit
3. Eczema Area and Severity Index (EASI) score ≥ 12
4. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)
5. AD involvement ≥ 10% of BSA
6. Severe pruritus (according to the definition of the pruritus categorical scale [PCS]) on at least 3 of the last 7 days before the visit
7. Documented recent history (within 6 months before the visit) of inadequate response to topical medications |
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E.4 | Principal exclusion criteria |
- Body weight < 45 kg
- Subjects with a medical history of asthma that fulfil any one or more of the scenarios below:
* Had an asthma exacerbation requiring hospitalization in the last 12 months before screening visit
* Whose asthma has not been well-controlled (i.e. symptoms >2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the last 3 months before the screening visit
* Peak Expiratory Flow (PEF) <80% of the predicted value
- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period.
- Pregnant women (with a positive serum pregnancy test result at the screening visit), breastfeeding women, or women planning to become pregnant during the clinical trial
- History of intolerance to low or mid potency TCS or for whom TCS is not advisable (e.g. hypersensitivity to TCS or to any other ingredient contained in the TCSs to be used in the study, significant skin atrophy) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change in EASI |
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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 subjects achieving IGA success
2. Percent change in EASI
3. Absolute and percent change of the peak and average pruritus
4. Proportion of subjects with an improvement of weekly pruritus peak
5. Absolute and percent change in weekly sleep disturbance
6. Proportion of subjects achieving pruritus categorical scale success
7. Proportion of subjects achieving 50%, 75% or 90% reduction from baseline in EASI score
8. Absolute and percent change in scoring atopic dermatitis |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. at each visit up to week 24
2. from baseline at each visit up to week 24
3. from baseline in weekly at each visit up to week 24
4. from baseline to week 24
5. from baseline to week 24
6. at week 24
7. from baseline to week 24
8. from baseline to week 24 |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 4 |
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 | 5 |
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 |
Canada |
France |
Germany |
Poland |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |