Atopic Dermatitis, Pruritus
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.
Detailed description
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis. Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups. Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total). All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.
Interventions
DRUGOrvepitant
Tablet, once daily, oral
DRUGPlacebo
Tablet, once daily, oral
Sponsors
Nerre Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition * Subjects must have chronic (\> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines * Subjects must have atopic dermatitis with a severity \> 3 on the IGA and EASI ≥12 at Screening visit/Visit 1 Key
Exclusion criteria
* Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus * Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic * Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2 * Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Itch Intensity - Numeric Rating Scale | Week 12 | Change from baseline in the mean worst NRS pruritus intensity scores recorded by the subject during the last 3 days of available values in the period prior to the week 12 visit |
Outcome results
None listed