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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117060
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 152020 tablet Drug: LEO 152020 placebo tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.

Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : January 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.

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.

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 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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117060


Contacts
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Contact: Clinical Disclosure (+1) 877-557-1168 clinicaltrialscontactus@leo-pharma.com

Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT05117060    
Other Study ID Numbers: LP0190-1488
2020-004561-39 ( EudraCT Number )
U1111-1281-1895 ( Other Identifier: World Health Organization (WHO) )
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.
URL: http://leopharmatrials.com/for-professionals

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases