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

JRCT ID: jRCT2031210485

Registered date:14/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 14/03/2022
• Target sample size: 224
• Countries of recruitment: Australia,Japan,Canada,Japan,US,Japan,Spain,Japan,Germany,Japan,Poland,Japan,Czech Republic,Japan
• Study type: Interventional

Intervention(s)

Participants will be asked to take LEO 152020 tablets or LEO 152020 placebo tablets from Week 0 to Week 16.
LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R) and prevent histamine from binding to the receptor. LEO 152020 is a tablet for oral administration.

Outcome(s)

• Primary Outcome: Change in EASI from baseline to Week 16

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kikuchi Aki
• Secondary ID(s): NCT05117060