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

  • STATUS
    Recruiting
  • End date
    Jan 6, 2023
  • participants needed
    224
  • sponsor
    LEO Pharma
Updated on 4 May 2022
eczema
topical agents

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.

Details
Condition Atopic Dermatitis
Treatment LEO 152020 Tablet, LEO 152020 placebo tablet
Clinical Study IdentifierNCT05117060
SponsorLEO Pharma
Last Modified on4 May 2022

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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