Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

Phase 2

• Conditions: Atopic Dermatitis

• Registration Number: JPRN-jRCT2031210485
• Lead Sponsor: Kikuchi Aki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Adult, age 18 years or older at screening.
- Diagnosis of chronic atopic dermatitis (AD).
- History of AD more than or equal to 1 year prior to baseline.
- Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
- Eczema Area and Severity Index (EASI) between 7.1 and 50 at baseline.
- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score more than or equal to 3 at baseline

Exclusion Criteria

- Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
- Previous treatment with 3 or more systemic AD treatments prior to screening.
- Women who are pregnant, intend to become pregnant, or are lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in EASI from baseline to Week 16