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 - CZPL389A2203 (ZEST)

ovartis0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

研究概览

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•- Females and males aged 18 years or older
•- Chronic atopic dermatitis (according to AADConsensus Criteria), that has been present for at least 1 year before the Baseline visit.
•- Moderate to severe atopic dermatitis defined as:
•- Eczema Area and Severity Index (EASI) >=16 at Screening and Baseline
•- IGA 3 or 4 at Screening and Baseline
•- Body Surface Area involvement >=10% at Screening and Baseline
•- Average peak pruritus score >=3 as assessed by NRS over the last 7 days prior to Baseline
•- Documented recent history (within 6 months before the screening visit) of inadequate
•response to treatment with topical medications for AD or for whom topical treatments are
•otherwise medically inadvisable
•- Have applied a stable dose of bland topical emollient once daily for at least the 7 consecutive days immediately before the baseline visit

•- Any skin disease that, in the opinion of the investigator, would confound the diagnosis or
•evaluation of AD disease activity
•- Risk factors for Torsades de Pointes (TdP)
•- Resting QTcF >=450 msec (male) or >=470 msec (female) at Screening or Baseline or inability to determine the QTcF interval
•- Cardiac or cardiac repolarization abnormality
•- Subjects with pre-existing conditions that may confound ability to diagnose drug-induced
•liver injury (DILI) or subjects with factors that increase susceptibility to DILI
•- Subjects who have a laboratory abnormality at Screening as follows:
•- ALT/AST, ALP or TBL above upper limit of normal (ULN)
•- Total white blood cell count (WBC) <2.5 x 109cells/L
•- Absolute neutrophil count (ANC) <1.5 x 109/L (one re-test is allowed during the screening period)
•- Hemoglobin <11.0 g/dL
•- Platelets <100.0 x 109/L
•- Potassium and magnesium outside normal range
•- eGFR by MDR equation <60 mL/minute/1.73 m2
•- Past medical history record of, or current infection with, human immunodeficiency virus (HIV)

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