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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004561-39 | EudraCT Number | ||
| U1111-1281-1895 | Other Identifier | World Health Organization (WHO) |
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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 152020 tablet - Dose regimen 1 | Experimental | Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). |
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| LEO 152020 tablet - Dose regimen 2 | Experimental | Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). |
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| LEO 152020 tablet - Dose regimen 3 | Experimental | Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). |
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| LEO 152020 placebo tablet | Placebo Comparator | Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 152020 tablet | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Beverly Hills | California | 90212 | United States | ||
| LEO Pharma Investigational Site |
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De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
285 subjects were screened and 216 were randomized in a 4:3:3:4 ratio into the 4 treatment groups.
This trial was conducted at 45 sites that screened subjects in 8 countries (Australia, Canada, Czech Republic (Czechia), Germany, Japan, Poland, Spain and the United States).
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 152020 - Dosing Regimen 1 (Higher Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally. |
| FG001 | LEO 152020 - Dosing Regimen 2 (Middle Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2022 |
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The outcome assessor is considered to be the person/people who will assess the outcome of the data/study and will in this study therefore be the sponsor.
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.
| LEO 152020 placebo tablet | Drug | 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. |
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| Los Angeles |
| California |
| 90045 |
| United States |
| LEO Pharma Investigational Site | San Diego | California | 92123 | United States |
| LEO Pharma Investigational Site | Cincinnati | Ohio | 45219 | United States |
| LEO Pharma Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| LEO Pharma Investigational Site | Frisco | Texas | 75034 | United States |
| LEO Pharma Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| LEO Pharma Investigational Site | Kogarah | New South Wales | 2217 | Australia |
| LEO Pharma Investigational Site | Sydney | New South Wales | 2010 | Australia |
| LEO Pharma Investigational Site | Woolloongabba | Queensland | 4102 | Australia |
| LEO Pharma Investigational Site | Carlton | Victoria | 3053 | Australia |
| LEO Pharma Investigational Site | Clayton | Victoria | 3168 | Australia |
| LEO Pharma Investigational Site | Calgary | Alberta | T2J 7E1 | Canada |
| LEO Pharma Investigational Site | Calgary | Alberta | T3E 0B2 | Canada |
| LEO Pharma Investigational Site | Edmonton | Alberta | T5J 3S9 | Canada |
| LEO Pharma Investigational Site | Markham | Ontario | L3P 1X3 | Canada |
| LEO Pharma Investigational Site | Mississauga | Ontario | L4Y 4C5 | Canada |
| LEO Pharma Investigational Site | Niagara Falls | Ontario | L2H 1H5 | Canada |
| LEO Pharma Investigational site | Québec | Quebec | G1V 4X7 | Canada |
| LEO Pharma Investigational Site | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| LEO Pharma Investigational Site | Karlovy Vary | 360 01 | Czechia |
| LEO Pharma Investigational Site | Kutná Hora | 284 01 | Czechia |
| LEO Pharma Investigational Site | Nový Jičín | 741 01 | Czechia |
| LEO Pharma Investigational Site | Ostrava-Poruba | 708 52 | Czechia |
| LEO Pharma Investigational Site | Prague | 100 34 | Czechia |
| LEO Pharma Investigational Site | Bad Bentheim | 48455 | Germany |
| LEO Pharma Investigational Site | Berlin | 10789 | Germany |
| LEO Pharma Investigational Site | Hanover | 30625 | Germany |
| LEO Pharma Investigational Site | Magdeburg | 39120 | Germany |
| LEO Pharma Investigational Site | Merzig | 66663 | Germany |
| LEO Pharma Investigational Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| LEO Pharma Investigational Site | Fukutsu-shi | Fukuoka | 811-3217 | Japan |
| LEO Pharma Investigational Site | Kumamoto | Kumamoto | 861-4101 | Japan |
| LEO Pharma Investigational Site | Takatsuki-shi | Osaka | 569-0824 | Japan |
| LEO Pharma Investigational Site | Koto-ku | Tokyo | 136-0074 | Japan |
| LEO Pharma Investigational Site | Minato-ku | Tokyo | 108-0014 | Japan |
| LEO Pharma Investigational Site | Krakow | 30-033 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-436 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-081 | Poland |
| LEO Pharma Investigational Site | Mikołów | 43-190 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-124 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-685 | Poland |
| LEO Pharma Investigational Site | Córdoba | 14004 | Spain |
| LEO Pharma Investigational Site | Madrid | 28046 | Spain |
| LEO Pharma Investigational Site | Pontevedra | 36001 | Spain |
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally. |
| FG002 | LEO 152020 - Dosing Regimen 3 (Lower Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally. |
| FG003 | LEO 152020 - Placebo | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 152020 - Dosing Regimen 1 (Higher Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally. |
| BG001 | LEO 152020 - Dosing Regimen 2 (Middle Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally. |
| BG002 | LEO 152020 - Dosing Regimen 3 (Lower Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally. |
| BG003 | LEO 152020 - Placebo | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | FAS, full analysis set. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 0 to Week 16 |
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| 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). | SAF, safety analysis set | Posted | Number | events | Week 0 to Week 16+3 days |
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Week 0 to Week 16+3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEO 152020 - Dosing Regimen 1 (Higher Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally. | 0 | 61 | 0 | 61 | 29 | 61 |
| EG001 | LEO 152020 - Dosing Regimen 2 (Middle Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally. | 0 | 45 | 2 | 45 | 24 | 45 |
| EG002 | LEO 152020 - Dosing Regimen 3 (Lower Dose) | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally. | 0 | 49 | 1 | 49 | 23 | 49 |
| EG003 | LEO 152020 - Placebo | Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally. | 0 | 61 | 0 | 61 | 24 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema herpeticum | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma A/S | +45 44945888 | disclosure@leo-pharma.com |
| Apr 10, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| Czechia |
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| Germany |
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| Japan |
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| Poland |
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| Spain |
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| United States |
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| LEO 152020 - Placebo |
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally. |
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