A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223954

Enrollment

Registered

2018-06-22

Start date

2019-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

investigational material(s) Generic name etc : ZPL389 INN of investigational material : - Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Subjects must give a written, signed and dated informed consent *Chronic atopic dermatitis present for at least 1 year before Baseline *Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA *Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable *Candidate for systemic treatment

Exclusion criteria

Exclusion criteria: *Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity *Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer *History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes *Participation in prior ZPL389 studies Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
efficacy IGA response at Week 16 [ Time Frame: week 16 ] IGA is an Investigator's global assessment of severity of atopic dermatitis.	—

Secondary

Measure	Time frame
efficacy Percentage change from baseline in EASI score at week 16 [ Time Frame: week 16 ] Eczema Area and Severity Index (EASI) is used to assess the extend and severity of AD efficacy EASI score and response over time [ Time Frame: at each visit per protocol, up to week 20 ] Eczema Area and Severity Index (EASI) score efficacy IGA score and response over time [ Time Frame: at each visit per protocol, up to week 20 ] Investigator's Global Assessment (IGA) score safety frequency of adverse events [ Time Frame: up to week 20 ] Clinical safety and tolerability will be assessed by adverse events monitoring	—

Measure

Time frame

efficacy Percentage change from baseline in EASI score at week 16 [ Time Frame: week 16 ] Eczema Area and Severity Index (EASI) is used to assess the extend and severity of AD efficacy EASI score and response over time [ Time Frame: at each visit per protocol, up to week 20 ] Eczema Area and Severity Index (EASI) score efficacy IGA score and response over time [ Time Frame: at each visit per protocol, up to week 20 ] Investigator's Global Assessment (IGA) score safety frequency of adverse events [ Time Frame: up to week 20 ] Clinical safety and tolerability will be assessed by adverse events monitoring

—

Countries

Asia except Japan, Europe, Japan, North America

Contacts

Public ContactHideki Maruyama

Novartis Pharma K. K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026