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

Study Overview
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Brief Summary
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This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new tablet (LEO 152020) to see if it works to treat AD and what the side effects are when compared with a placebo tablet with no medical ingredient. During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms, itch, sleep, and quality of life.

Official Title
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A Phase 2 Trial to Evaluate the Efficacy and Safety of Orally Administered LEO 152020 Tablets Compared With Placebo Tablets for up to 16 Weeks of Treatment in Adults With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: LEO 152020 tablet
* Drug: LEO 152020 placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, age 18 years or older at screening. Diagnosis of chronic atopic dermatitis (AD). History of AD ≥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. 7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline. Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 152020 tablet - Dose regimen 1<br>Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). | Drug: LEO 152020 tablet<br>* 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.<br>|
| Experimental: LEO 152020 tablet - Dose regimen 2<br>Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). | Drug: LEO 152020 tablet<br>* 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.<br>|
| Experimental: LEO 152020 tablet - Dose regimen 3<br>Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). | Drug: LEO 152020 tablet<br>* 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.<br>|
| Placebo Comparator: LEO 152020 placebo tablet<br>Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). | Drug: LEO 152020 placebo tablet<br>* LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except the medical ingredient LEO 152020.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EASI from baseline to Week 16 | The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition. | Week 0 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events from baseline to Week 16+3 days per subject | Only treatment-emergent adverse events will be reported for this outcome measure. An adverse event will be considered treatment emergent if occurring after the first dose of treatment (Week 0) and up until 3 days after the last dose of treatment (Week 16+3 days for a participant completing the 16-week treatment period). | Week 0 to Week 16+3 days |