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
Overview
- Phase
- Phase 2
- Intervention
- LEO 152020 tablet
- Conditions
- Atopic Dermatitis
- Sponsor
- JW Pharmaceutical
- Enrollment
- 216
- Locations
- 2
- Primary Endpoint
- Change in EASI From Baseline to Week 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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 improves 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
LEO 152020 tablet - Dose regimen 1
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 tablet
LEO 152020 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 tablet
LEO 152020 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 placebo tablet
LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 tablet
LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 placebo tablet
LEO 152020 placebo tablet
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention: LEO 152020 placebo tablet
Outcomes
Primary Outcomes
Change in EASI From Baseline to Week 16
Time Frame: Week 0 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.
Secondary Outcomes
- Number of Adverse Events From Baseline to Week 16+3 Days Per Subject(Week 0 to Week 16+3 days)