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

June 2, 2024 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • LEO Pharma Investigational Site
      • Kogarah, New South Wales, Australia, 2217
        • LEO Pharma Investigational Site
      • Sydney, New South Wales, Australia, 2010
        • LEO Pharma Investigational Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • LEO Pharma Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • LEO Pharma Investigational Site
      • Clayton, Victoria, Australia, 3168
        • LEO Pharma Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • LEO Pharma Investigational Site
      • Calgary, Alberta, Canada, T3E 0B2
        • LEO Pharma Investigational Site
      • Edmonton, Alberta, Canada, T5J 3S9
        • LEO Pharma Investigational Site
    • Ontario
      • Markham, Ontario, Canada, L3P 1X3
        • LEO Pharma Investigational Site
      • Mississauga, Ontario, Canada, L4Y 4C5
        • LEO Pharma Investigational Site
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • LEO Pharma Investigational Site
    • Quebec
      • Québec, Quebec, Canada, G1V 4X7
        • LEO Pharma Investigational Site
      • Saint-Jerome, Quebec, Canada, J7Z 7E2
        • LEO Pharma Investigational Site
  • Czechia
      • Karlovy Vary, Czechia, 360 01
        • LEO Pharma Investigational Site
      • Kutna Hora, Czechia, 284 01
        • LEO Pharma Investigational Site
      • Novy Jicin, Czechia, 741 01
        • LEO Pharma Investigational Site
      • Ostrava-Poruba, Czechia, 708 52
        • LEO Pharma Investigational Site
      • Prague 10, Czechia, 100 34
        • LEO Pharma Investigational Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • LEO Pharma Investigational Site
      • Berlin, Germany, 10789
        • LEO Pharma Investigational Site
      • Hannover, Germany, 30625
        • LEO Pharma Investigational Site
      • Magdeburg, Germany, 39120
        • LEO Pharma Investigational Site
      • Merzig, Germany, 66663
        • LEO Pharma Investigational Site
  • Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • LEO Pharma Investigational Site
      • Fukutsu-shi, Fukuoka, Japan, 811-3217
        • LEO Pharma Investigational Site
    • Kumamoto
      • Kumamoto-city, Kumamoto, Japan, 861-4101
        • LEO Pharma Investigational Site
    • Osaka
      • Takatsuki-shi, Osaka, Japan, 569-0824
        • LEO Pharma Investigational Site
    • Tokyo
      • Koto-ku, Tokyo, Japan, 136-0074
        • LEO Pharma Investigational Site
      • Minato-ku, Tokyo, Japan, 108-0014
        • LEO Pharma Investigational Site
  • Poland
      • Krakow, Poland, 30-033
        • LEO Pharma Investigational Site
      • Lodz, Poland, 90-436
        • LEO Pharma Investigational Site
      • Lublin, Poland, 20-081
        • LEO Pharma Investigational Site
      • Mikolow, Poland, 43-190
        • LEO Pharma Investigational Site
      • Wroclaw, Poland, 51-685
        • LEO Pharma Investigational Site
      • Wrocław, Poland, 51-124
        • LEO Pharma Investigational Site
  • Spain
      • Cordoba, Spain, 14004
        • LEO Pharma Investigational Site
      • Madrid, Spain, 28046
        • LEO Pharma Investigational Site
      • Pontevedra, Spain, 36001
        • LEO Pharma Investigational Site
  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • LEO Pharma Investigational Site
      • Los Angeles, California, United States, 90045
        • LEO Pharma Investigational Site
      • San Diego, California, United States, 92123
        • LEO Pharma Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • LEO Pharma Investigational Site
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • LEO Pharma Investigational Site
    • Texas
      • Frisco, Texas, United States, 75034
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEO 152020 tablet - Dose regimen 1
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Drug: 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.
Experimental: LEO 152020 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Drug: 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.
Drug: 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.
Experimental: LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Drug: 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.
Drug: 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.
Placebo Comparator: LEO 152020 placebo tablet
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EASI From Baseline to Week 16
Time Frame: Week 0 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
Time Frame: Week 0 to Week 16+3 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Collaborators

LEO Pharma

Investigators

  • Study Director: Medical Expert, LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

July 20, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0190-1488
  • 2020-004561-39 (EudraCT Number)
  • U1111-1281-1895 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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