A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080223954
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 55
*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
*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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>IGA response at Week 16 [ Time Frame: week 16 ]<br>IGA is an Investigator's global assessment of severity of atopic dermatitis.
- Secondary Outcome Measures
Name Time Method efficacy<br>Percentage change from baseline in EASI score at week 16 [ Time Frame: week 16 ]<br>Eczema Area and Severity Index (EASI) is used to assess the extend and severity of AD<br>efficacy<br>EASI score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]<br>Eczema Area and Severity Index (EASI) score<br>efficacy<br>IGA score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]<br>Investigator's Global Assessment (IGA) score<br>safety<br>frequency of adverse events [ Time Frame: up to week 20 ]<br>Clinical safety and tolerability will be assessed by adverse events monitoring