ZEST Extension
Research type
Research Study
Full title
A randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the short-term and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)
IRAS ID
259573
Contact name
Dania Calboli
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-000595-15
Duration of Study in the UK
2 years, 5 months, 13 days
Research summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease that commonly presents during childhood. It results in itchy, red, swollen and cracked skin. These symptoms result in a severely reduced quality of life. Itching (pruritus) causes sleep loss and therefore impacts everyday activities and wellbeing. Up to 10% of adults and up to 20% of children have atopic dermatitis. Patients suffering from more severe disease and failing to respond to treatment such as steroid creams are generally treated with a. light therapy (which carries the risk of future skin cancer and is not practical for many subjects) and b. oral or injectable immunosuppressive drugs such as ciclosporin (but risk of kidney injury and high blood pressure limit long-term use).
Currently the only injectable therapy approved for treatment of moderate to severe AD is dupilumab, but it is expected that it will only be prescribed for severe patients who have failed to improve on other treatments. There is an unmet medical need for oral treatment in moderate to severe AD patients. ZPL389 is taken daily as an oral tablet. Histamine, which is naturally produced in the body under certain circumstances, causes inflammation and itch. The study drug, ZPL389 is thought to inhibit these inflammatory responses and the associated itch.
The purpose of this study (CZPL389A2203E1) is to understand how safe and effective ZPL389 30mg and 50mg doses are when used intermittently with topical corticosteroids and/or topical calcineurin inhibitors for up to 2 years in AD adult patients who previously completed treatment with ZPL389 in the previous ZEST study (CZPL389A2203).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0048
Date of REC Opinion
12 Mar 2019
REC opinion
Favourable Opinion