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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LEO 152020 tablet
LEO 152020 placebo tablet
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma INvestigational Sitew
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LEO 152020 tablet - Dose regimen 1

LEO 152020 tablet - Dose regimen 2

LEO 152020 tablet - Dose regimen 3

LEO 152020 placebo tablet

Arm Description

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
November 8, 2021
Last Updated
August 9, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05117060
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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 1 and LEO 152020 tablet - Dose regimen 2 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.
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 152020 tablet - Dose regimen 1
Arm Type
Experimental
Arm Description
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Arm Title
LEO 152020 tablet - Dose regimen 2
Arm Type
Experimental
Arm Description
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Arm Title
LEO 152020 tablet - Dose regimen 3
Arm Type
Experimental
Arm Description
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Arm Title
LEO 152020 placebo tablet
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Intervention Type
Drug
Intervention Name(s)
LEO 152020 tablet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LEO 152020 placebo tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in EASI from baseline to Week 16
Description
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.
Time Frame
Week 0 to Week 16
Secondary Outcome Measure Information:
Title
Number of adverse events from baseline to Week 16+3 days per subject
Description
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).
Time Frame
Week 0 to Week 16+3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
LEO Pharma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
LEO Pharma Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
LEO Pharma Investigational Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
LEO Pharma Investigational Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
LEO Pharma Investigational Site
City
Sydney
ZIP/Postal Code
2010
Country
Australia
Facility Name
LEO Pharma Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2H 1H5
Country
Canada
Facility Name
LEO Pharma Investigational site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Saint-Jérome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Kutná Hora
State/Province
Czech Republic
ZIP/Postal Code
28401
Country
Czechia
Facility Name
LEO Pharma Investigational Site
City
Karlovy Vary
ZIP/Postal Code
360 01
Country
Czechia
Facility Name
LEO Pharma INvestigational Sitew
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czechia
Facility Name
LEO Pharma Investigational Site
City
Ostrava-POruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
LEO Pharma Investigational Site
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
LEO Pharma Investigational Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Leo Pharma Investigational Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Leo Pharma Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Leo Pharma Investigational Site
City
Merzig
ZIP/Postal Code
66663
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Fukuoka
State/Province
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
LEO Pharma Investigational Site
City
Fukuoka-Shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
LEO Pharma Investigational Site
City
Fukutsu-shi
State/Province
Fukuoka
ZIP/Postal Code
811-3217
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Kumamoto-city
State/Province
Kumamoto
ZIP/Postal Code
861-4101
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-0824
Country
Japan
Facility Name
LEO Pharma Investigational Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
LEO Pharma Investigational Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Leo Pharma Investigational Site
City
Mikolow
ZIP/Postal Code
43-190
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
LEO Pharma Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
LEO Pharma Investigational Site
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data are available to request after results of the trial are available on leopharmatrials.com.
IPD Sharing Access Criteria
Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

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

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