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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05117060




Registration number
NCT05117060
Ethics application status
Date submitted
8/11/2021
Date registered
11/11/2021

Titles & IDs
Public title
Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
2020-004561-39
Secondary ID [2] 0 0
LP0190-1488
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LEO 152020 tablet
Treatment: Drugs - LEO 152020 placebo tablet

Experimental: LEO 152020 tablet - Dose regimen 1 - Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Experimental: LEO 152020 tablet - Dose regimen 2 - Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Experimental: LEO 152020 tablet - Dose regimen 3 - Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Placebo comparator: LEO 152020 placebo tablet - Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in EASI From Baseline to Week 16
Timepoint [1] 0 0
Week 0 to Week 16
Secondary outcome [1] 0 0
Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
Timepoint [1] 0 0
Week 0 to Week 16+3 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2023
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
LEO Pharma Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
LEO Pharma Investigational Site - Kogarah
Recruitment hospital [3] 0 0
LEO Pharma Investigational Site - Sydney
Recruitment hospital [4] 0 0
LEO Pharma Investigational Site - Woolloongabba
Recruitment hospital [5] 0 0
LEO Pharma Investigational Site - Carlton
Recruitment hospital [6] 0 0
LEO Pharma Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Karlovy Vary
Country [9] 0 0
Czechia
State/province [9] 0 0
Kutna Hora
Country [10] 0 0
Czechia
State/province [10] 0 0
Novy Jicin
Country [11] 0 0
Czechia
State/province [11] 0 0
Ostrava-Poruba
Country [12] 0 0
Czechia
State/province [12] 0 0
Prague 10
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Bentheim
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Hannover
Country [16] 0 0
Germany
State/province [16] 0 0
Magdeburg
Country [17] 0 0
Germany
State/province [17] 0 0
Merzig
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Kumamoto
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Poland
State/province [22] 0 0
Krakow
Country [23] 0 0
Poland
State/province [23] 0 0
Lodz
Country [24] 0 0
Poland
State/province [24] 0 0
Lublin
Country [25] 0 0
Poland
State/province [25] 0 0
Mikolow
Country [26] 0 0
Poland
State/province [26] 0 0
Wroclaw
Country [27] 0 0
Spain
State/province [27] 0 0
Cordoba
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Pontevedra

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
JW Pharmaceutical
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
LEO Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Expert
Address 0 0
LEO Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://leopharmatrials.com/for-professionals


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05117060