Clinical trial NCT05117060: Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: LEO Pharma
First posted: 2021-11-11
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in EASI From Baseline to Week 16
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
timeFrame: Week 0 to Week 16+3 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: San Diego
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Cincinnati
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Murfreesboro
country: United States
facility: LEO Pharma Investigational Site
state: Tennessee
city: Frisco
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Darlinghurst
country: Australia
facility: LEO Pharma Investigational Site
state: New South Wales
city: Kogarah
country: Australia
facility: LEO Pharma Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: LEO Pharma Investigational Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: LEO Pharma Investigational Site
state: Queensland
city: Carlton
country: Australia
facility: LEO Pharma Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: LEO Pharma Investigational Site
state: Victoria
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Markham
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Québec
country: Canada
facility: LEO Pharma Investigational site
state: Quebec
city: Saint-Jerome
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Karlovy Vary
country: Czechia
facility: LEO Pharma Investigational Site
city: Kutna Hora
country: Czechia
facility: LEO Pharma Investigational Site
city: Novy Jicin
country: Czechia
facility: LEO Pharma Investigational Site
city: Ostrava-Poruba
country: Czechia
facility: LEO Pharma Investigational Site
city: Prague 10
country: Czechia
facility: LEO Pharma Investigational Site
city: Bad Bentheim
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Hannover
country: Germany
facility: LEO Pharma Investigational Site
city: Magdeburg
country: Germany
facility: LEO Pharma Investigational Site
city: Merzig
country: Germany
facility: LEO Pharma Investigational Site
city: Fukuoka-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Fukuoka
city: Fukutsu-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Fukuoka
city: Kumamoto-city
country: Japan
facility: LEO Pharma Investigational Site
state: Kumamoto
city: Takatsuki-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Osaka
city: Koto-ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Krakow
country: Poland
facility: LEO Pharma Investigational Site
city: Lodz
country: Poland
facility: LEO Pharma Investigational Site
city: Lublin
country: Poland
facility: LEO Pharma Investigational Site
city: Mikolow
country: Poland
facility: LEO Pharma Investigational Site
city: Wroclaw
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Cordoba
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Pontevedra
country: Spain
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: