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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117060
• Other study ID #: LP0190-1488
• Secondary ID: 2020-004561-39U1
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2021
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2023
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: July 26, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 152020 tablet
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.
• LEO 152020 placebo tablet
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.

Locations

Country	Name	City	State
Australia	LEO Pharma Investigational Site	Carlton	Victoria
Australia	Leo Pharma Investigational Site	Clayton	Victoria
Australia	LEO Pharma Investigational Site	Darlinghurst	New South Wales
Australia	LEO Pharma Investigational Site	Kogarah	New South Wales
Australia	LEO Pharma Investigational Site	Sydney
Australia	LEO Pharma Investigational Site	Woolloongabba	Queensland
Canada	LEO Pharma Investigational Site	Calgary	Alberta
Canada	LEO Pharma Investigational Site	Calgary	Alberta
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
Canada	LEO Pharma Investigational Site	Markham	Ontario
Canada	Leo Pharma Investigational Site	Mississauga	Ontario
Canada	Leo Pharma Investigational Site	Niagara Falls	Ontario
Canada	LEO Pharma Investigational site	Québec	Quebec
Canada	LEO Pharma Investigational Site	Saint-Jérome	Quebec
Czechia	LEO Pharma Investigational Site	Karlovy Vary
Czechia	Leo Pharma Investigational Site	Kutná Hora	Czech Republic
Czechia	LEO Pharma INvestigational Sitew	Novy Jicin
Czechia	LEO Pharma Investigational Site	Ostrava-POruba
Czechia	LEO Pharma Investigational Site	Prague 10
Germany	LEO Pharma Investigational Site	Bad Bentheim
Germany	Leo Pharma Investigational Site	Berlin
Germany	LEO Pharma Investigational Site	Hannover
Germany	Leo Pharma Investigational Site	Magdeburg
Germany	Leo Pharma Investigational Site	Merzig
Japan	LEO Pharma Investigational Site	Fukuoka	Fukuoka-shi
Japan	LEO Pharma Investigational Site	Fukuoka-Shi	Fukuoka
Japan	LEO Pharma Investigational Site	Fukutsu-shi	Fukuoka
Japan	LEO Pharma Investigational Site	Koto-ku	Tokyo
Japan	Leo Pharma Investigational Site	Kumamoto-city	Kumamoto
Japan	LEO Pharma Investigational Site	Minato-ku	Tokyo
Japan	Leo Pharma Investigational Site	Takatsuki-shi	Osaka
Poland	Leo Pharma Investigational Site	Krakow
Poland	LEO Pharma Investigational Site	Lodz
Poland	LEO Pharma Investigational Site	Lublin
Poland	Leo Pharma Investigational Site	Mikolow
Poland	LEO Pharma Investigational Site	Wroclaw
Poland	LEO Pharma Investigational Site	Wroclaw
Spain	LEO Pharma Investigational Site	Córdoba
Spain	LEO Pharma Investigational Site	Madrid
Spain	LEO Pharma Investigational Site	Pontevedra
United States	LEO Pharma Investigational Site	Beverly Hills	California
United States	LEO Pharma Investigational Site	Cincinnati	Ohio
United States	LEO Pharma Investigational Site	Frisco	Texas
United States	Leo Pharma Investigational Site	Los Angeles	California
United States	Leo Pharma Investigational Site	Murfreesboro	Tennessee
United States	LEO Pharma Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Germany,  Japan,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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