None listed
Conditions
Interventions
Product Code: M5161
Pharmaceutical Form: Capsule, soft
Current Sponsor code: M5161
Other descriptive name: N-[(5R, 6R, 9R, 12-{4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino}butoxy}N-(methylsulfonyl)ace
Sponsors
Maruho Co, Ltd. Kyoto R&D Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult males or female patients aged 18-65 years inclusive with a diagnosis of AD. This diagnosis will be confirmed based on the Hanifin & Rajka diagnostic criteria (1980) by investigator assessment at screening. 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 ago; hormonal contraception (oestrogen + gestagen pill, depot injections, or subcutaneous (s.c.) 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 30 days after last intake of IMP. Patients who are able and willing to give signed ICF. Patients who have a self assessed mean pruritus score (a total of diurnal scores and nocturnal scores) =4 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have history of allergy to hydrocortisone. Patients who have history of relevant drug hypersensitivity. Patients who have history of contact dermatitis induced by a topical steroid. Patients who are currently pregnant (serum beta-hCG (human chorionic gonadotropin test)) or lactating. Patients who are taking and unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study. Patients who suffer from any cancer. Patients who have serious disability in their heart, liver and/or kidney. Patients who are not deemed eligible as determined by pre-study medical history, physical examination and clinical laboratory safety tests. Patients who have taken antiallergic drugs, antihistamines, nonsteroidal anti- inflammatory drugs, gamma-globulins, anti-cholinergic drugs, tranquilizers, hypnotics, antipsychotic drugs, cold remedies containing antihistamine component, and any other systemic antiallergic or antipruritic drugs within 1 day prior to Visit 1. Patients who have been treated with steroids (except inhaled preparations) or immunosuppressive drugs within two weeks of Visit 1.(Study-related topical hydrocortisone butyrate as 0.1% ointment will be allowed.) Patients who have used sustained-release depot preparations of steroids within 4 weeks of Visit 1. Patients who use emollients with a known antipruritic activity e.g. with menthol within 1 day prior to Visit 1. Patients who have started any new emollient within 1 week prior to Visit 1. Patients who have used any bath additive within 1 week prior to Visit 1. Patients who have pruritus associated with conditions other than AD. Patients who have pruritus only at the face and head. Patients who 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. Patients who have used any IMP and /or participated in any clinical trial within 3 months prior to Visit 1. Patients who cannot communicate reliably with the Investigator. Patients who have non compliance (defined as less than 80% or more than 120%) concerning IMP administration and hydrocortisone butyrate 0.1%. ointment application, assessments of pruritus score and VAS score during the lead-in observation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of M5161 in relieving pruritus associated with AD in the oral dose regimen of 5 µg and 10 µg b.i.d. for 14 days. ;Secondary Objective: To provide further information on the safety of M5161 in the oral dose regimen of 5 µg and 10 µg b.i.d. for 14 days. To assess the effects of M5161 on certain PD markers. ;Primary end point(s): Mean change in pruritus score from baseline | — |
Countries
United Kingdom
Outcome results
None listed