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

JRCT ID: jRCT2080224724

Registered date:17/06/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 17/06/2019
• Target sample size: 36
• Countries of recruitment: Japan,Asia except Japan,North America,Europe
• Study type: Interventional

Intervention(s)

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

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

safety
*Frequency of AEs at Week 32 and Week 116.

Secondary Outcome

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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Secondary ID(s): NCT03948334,JapicCTI-194800