A study to assess the safety and efficacy of ZPL389 doses in patients
Research type
Research Study
Full title
A randomized, double blind, placebo controlled multicenter dose ranging study to assess the safety and efficacy of multiple oral ZPL389 doses in patients with moderate to severe Atopic Dermatitis (ZEST trial)
IRAS ID
245185
Contact name
Schnekenbuehl Susanne
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-002176-75
Duration of Study in the UK
1 years, 1 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 (QOL). Itching (pruritus) causes sleep loss and therefore impacts everyday activities and psychosocial wellbeing. Approximately 2 - 10% of adults and <20% of children have AD, of which approximately 70% and 16%, respectively, are moderate to severe. Patients suffering from more severe disease and failing to sustain response to topical agents are generally treated with phototherapy (which carries the risk of future skin cancer and is not practical for many subjects) and systemic immunosuppressive drugs such as ciclosporin (but renal toxicity and other adverse events limit its long-term use). Currently the only systemic therapy approved is dupilumab for treatment of moderate to severe AD, but is expected to be prescribed for severe patients who have failed on other treatments. There is an unmet medical need for oral treatment in moderate to severe AD patients. ZPL389 is an taken daily as an oral tablet. ZPL389 binds to the histamine 4 receptor (H4R). Histamine, naturally produced in the body under certain circumstances, binds to H4R which causes inflammation and itch. When ZPL389 binds to H4R, it prevents histamine from binding, and it is thought to thereby inhibit inflammation and itch.
The Study design is a randomized, double-blind, placebo controlled multi-centre trial to understand:
1. If ZPL389 can help to treat patients with moderate to severe AD
2. If it is safe for AD patients to take ZPL389
3. Which dose of ZPL389 works best
4. If using ZPL389 treatment is better than placebo.
360 patients will be recruited worldwide, participating in the study for approximately 6 months including a 16 week treatment period and the 4 week follow-up period.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0109
Date of REC Opinion
6 Jun 2018
REC opinion
Further Information Favourable Opinion