| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Pruritus associated with Atopic dermititis |
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| MedDRA Classification |
| 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 efficacy endpoint is the mean change in VAS score during the comparative treatment period (i.e. from Day 2 through to the morning of Visit 4 / Visit after Early Withdrawal) compared to baseline*.
* baseline: the mean score in the patient-selection period. |
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| E.2.2 | Secondary objectives of the trial |
The secondary efficacy endpoints are:
•Mean change in pruritus score during the comparative treatment period (i.e. from Day 2 through to the morning of Visit 4 / Visit after Early Withdrawal) compared to baseline*.
•Mean change in VAS score for the first 7 days of the comparative treatment period (i.e. from Day 2 through to Day 8) compared to baseline*.
•Mean change in pruritus score for the first 7 days of the comparative treatment period (i.e. from Day 2 through to Day 8) compared to baseline*.
•Time course changes in VAS score.
•Time course changes in pruritus score.
•Time course changes of the SCORAD index.
* baseline: the mean score in the patient-selection period
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
The inclusion criteria are to be verified at the Screening visit, and reviewed at the start of the lead-in (Visit 1) and comparative treatment periods (Visit 2). Patients must have met all of the following inclusion criteria by Visit 2 to be eligible to participate in the double-blind treatment period of this study:
Screening visit
1)Male or female patients (aged 18-65 years, inclusive, on the day of signing the informed consent form [ICF]) with a diagnosis of AD. This diagnosis will be confirmed using the Hanifin and Rajka diagnostic criteria1 by investigator assessment at screening.
2)Female patients of child bearing potential† must be using a medically acceptable form of contraception. The following options are acceptable: intra-uterine device, bilateral tubal ligation, abstinence from intercourse, partner's vasectomy >3 months previously, hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide); combination of two barrier methods. Patients must consent for continued reliable contraception during the study and until 30 days after last intake of IMP.
3)Patients who are able and willing to give signed informed consent.
Visit 1 (start of single-blind treatment period)
1)Patients who have a self assessed pruritus score (a total of the diurnal score and the nocturnal score on the day before Visit 1) ≥ 4 points at Visit 1 (Day -7).
Visit 2 (start of double-blind treatment period)
1)Patients who have a self assessed mean pruritus score (a total of diurnal scores and nocturnal scores) ≥ 4.0 points for the patient-selection period (i.e. from the evening of Day 3 to the morning of Day 1).
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| E.4 | Principal exclusion criteria |
The exclusion criteria are to be verified at the Screening visit, and reviewed at the start of the lead-in (Visit 1) and comparative treatment periods (Visit 2). If the patient meets any of the following exclusion criteria at any of these visits, he/she is not eligible to participate in the double-blind treatment period of this study:
Screening visit
1)Patients who have a history of allergy to hydrocortisone.
2)Patients who have a history of relevant drug hypersensitivity.
3)Patients who have a history of contact dermatitis induced by a topical steroid.
4)Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
5)Patients who have a history or presence of any cancer.
6)Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
7)Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
8)Patients who have pruritus associated with conditions other than AD (e.g. prurigo nodularis and seborrheic eczema).
9)Patients who have pruritus only on the face and head.
10)Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
11)Patients who have used M5161 (active ingredient of M516102; nalfurafine).
12)Patients who cannot communicate reliably with the investigator.
Visit 1 (start of single-blind treatment period)
Since a 4 week screening period is allowed for this study, the following exclusion criteria may not apply if the necessary delay occurs before Visit 1, and the patient agrees not to take the medications or therapy prohibited by the protocol from the initial Screening visit until completion of the study. Signed informed consent must be obtained before any wash-out periods starts.
1)Patients who are pregnant [based on urine pregnancy test], or lactating.
2)Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
3)Patients who have used any IMP and/or participated in any clinical trial within 3 months before Visit 1.
4)Patients who have used sustained-release depot preparations of steroids within 4 weeks before Visit 1.
5)Patients who have been treated with immediate-release steroids (except topical and inhaled preparations; see Section 4.2.3) or immunosuppressive/immunomodulative drugs within 2 weeks before Visit 1.
6)Patients who have started any new emollient within 1 week before Visit 1.
7)Patients who have taken anti-allergic drugs, antihistamines, gamma-globulins, anti-cholinergic drugs, tranquilizers, hypnotics, antipsychotic drugs, cold remedies containing an antihistamine component, or any other systemic anti-allergic or anti-pruritic drugs within 1 day before Visit 1.
Visit 2 (start of double-blind treatment period)
1)Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
2)Patients whose number of pruritus scores during the patient-selection period (maximum of six) from information recorded on the daily diary card is three or less.
3)Patients whose number of doses of IMP taken from the evening of Day 7 to the morning of Day 1 (maximum of 14) is 11 or less, or 17 or more.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the mean change in VAS score during the comparative treatment period (i.e. from Day 2 through to the morning of Visit 4 / Visit after Early Withdrawal) compared to baseline*.
* baseline: the mean score in the patient-selection period.
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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 | No |
| 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.8.3 |
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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 34 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| 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
| |
| 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 | 5 |
| 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 | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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