A study to assess the safety and efficacy of ZPL389 with concomitant or intermittent use of TCS and/or TCI in atopic dermatitis patients.

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 Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224724

Enrollment

Registered

2019-06-17

Start date

2019-06-17

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 mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Subjects must give a written, signed and dated informed consent *Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study. *Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion criteria

Exclusion criteria: *Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions). *Treatment discontinued subject from CZPL389A2203 study. *Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.

Design outcomes

Primary

Measure	Time frame
safety *Frequency of AEs at Week 32 and Week 116.	—

Secondary

Measure	Time frame
efficacy Investigator's global assessment response.[ Time Frame: Investigator's global assessment rating score up to Week 120 ] Eczema Area and Severity Index (EASI) score. [ Time Frame: EASI-50/EASI-75 response up to Week 120 ]	—

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