Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
NCT ID: NCT05117060
Last Updated: 2024-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2021-12-13
2023-07-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
To ensure masking across the interventions, each dose of treatment in the LEO 152020 tablet - Dose regimen 2 and LEO 152020 tablet - Dose regimen 3 arms will consist of a combination of LEO 152020 and LEO 152020 placebo tablets. In these arms, placebo will be used as a masking aid and is therefore considered neither a control nor an intervention.
Study Groups
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LEO 152020 tablet - Dose regimen 1
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
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 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
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 tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.
LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
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 tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.
LEO 152020 placebo tablet
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
LEO 152020 placebo tablet
LEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.
Interventions
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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 tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.
Eligibility Criteria
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Inclusion Criteria
* 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 3 or more systemic AD treatments prior to screening.
* Women who are pregnant, intend to become pregnant, or are lactating.
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma Investigational Site
Clayton, Victoria, Australia
LEO Pharma Investigational Site
Calgary, Alberta, Canada
LEO Pharma Investigational Site
Calgary, Alberta, Canada
LEO Pharma Investigational Site
Beverly Hills, California, United States
LEO Pharma Investigational Site
Los Angeles, California, United States
LEO Pharma Investigational Site
San Diego, California, United States
LEO Pharma Investigational Site
Cincinnati, Ohio, United States
LEO Pharma Investigational Site
Murfreesboro, Tennessee, United States
LEO Pharma Investigational Site
Frisco, Texas, United States
LEO Pharma Investigational Site
Darlinghurst, New South Wales, Australia
LEO Pharma Investigational Site
Kogarah, New South Wales, Australia
LEO Pharma Investigational Site
Sydney, New South Wales, Australia
LEO Pharma Investigational Site
Woolloongabba, Queensland, Australia
LEO Pharma Investigational Site
Carlton, Victoria, Australia
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-Jérôme, Quebec, Canada
LEO Pharma Investigational Site
Karlovy Vary, , Czechia
LEO Pharma Investigational Site
Kutná Hora, , Czechia
LEO Pharma Investigational Site
Nový Jičín, , Czechia
LEO Pharma Investigational Site
Ostrava-Poruba, , Czechia
LEO Pharma Investigational Site
Prague, , Czechia
LEO Pharma Investigational Site
Bad Bentheim, , Germany
LEO Pharma Investigational Site
Berlin, , Germany
LEO Pharma Investigational Site
Hanover, , Germany
LEO Pharma Investigational Site
Magdeburg, , Germany
LEO Pharma Investigational Site
Merzig, , Germany
LEO Pharma Investigational Site
Fukuoka, Fukuoka, Japan
LEO Pharma Investigational Site
Fukutsu-shi, Fukuoka, Japan
LEO Pharma Investigational Site
Kumamoto, Kumamoto, Japan
LEO Pharma Investigational Site
Takatsuki-shi, Osaka, Japan
LEO Pharma Investigational Site
Koto-ku, Tokyo, Japan
LEO Pharma Investigational Site
Minato-ku, Tokyo, Japan
LEO Pharma Investigational Site
Krakow, , Poland
LEO Pharma Investigational Site
Lodz, , Poland
LEO Pharma Investigational Site
Lublin, , Poland
LEO Pharma Investigational Site
Mikołów, , Poland
LEO Pharma Investigational Site
Wroclaw, , Poland
LEO Pharma Investigational Site
Wroclaw, , Poland
LEO Pharma Investigational Site
Córdoba, , Spain
LEO Pharma Investigational Site
Madrid, , Spain
LEO Pharma Investigational Site
Pontevedra, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-004561-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1281-1895
Identifier Type: OTHER
Identifier Source: secondary_id
LP0190-1488
Identifier Type: -
Identifier Source: org_study_id
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