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

Phase 2

Recruiting

• Conditions: atopic eczema; Neurodermitis; 10014982

• Registration Number: NL-OMON48764
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- 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

Exclusion Criteria

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To characterize the dose-response relationship of ZPL389 in subjects with<br /><br>moderate to severe AD assessed by IGA response after 16 weeks of treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To characterize the dose-response relationship of ZPL389 in subjects with<br /><br>moderate to severe AD assessed using the percent change from<br /><br>Baseline in Eczema Area and Severity Index (EASI) score after 16 weeks of<br /><br>treatment<br /><br>- To evaluate the efficacy across different dose levels as assessed by EASI and<br /><br>IGA compared to placebo over time<br /><br>- To assess the safety and tolerability of different doses of ZPL389 as<br /><br>compared to placebo</p><br>