Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
LP0190-1488

Research Trial for Atopic Dermatitis (22 Weeks)


Treatment: Oral Age: 18 Years

Adults aged 18 years or older with a diagnosis of chronic atopic dermatitis (AD), may qualify to participate. Individuals must have moderate to severe disease, with a history of AD for 1 year or more. AD must cover 5% or more body surface area. Recent documented history (within 6 months) of inadequate response to topical AD treatments or for whom topical AD treatments are otherwise medically inadvisable, is also required.

Participants will receive investigational oral medication (active study drug) or placebo, in tablet form. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 22 weeks and involve about 13 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

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

ClinicalTrials.gov ID

NCT05117060

Sponsor

LEO Pharma

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.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: LEO 152020 tablet
    Drug: LEO 152020 tablet
    Drug: LEO 152020 tablet
    Drug: LEO 152020 placebo tablet
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Stephen Shumack

Dermatologist

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