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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT05117060

Run by

JW Pharmaceutical

People needed

216

Starts

2021-12-13

Expected to finish

2023-07-26

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• LEO Pharma Investigational Site — Beverly Hills, California, United States
• LEO Pharma Investigational Site — Los Angeles, California, United States
• LEO Pharma Investigational Site — San Diego, California, United States
• LEO Pharma Investigational Site — Cincinnati, Ohio, United States
• LEO Pharma Investigational Site — Murfreesboro, Tennessee, United States
• LEO Pharma Investigational Site — Frisco, Texas, United States
• LEO Pharma Investigational Site — Darlinghurst, New South Wales, Australia
• LEO Pharma Investigational Site — Kogarah, New South Wales, Australia
• LEO Pharma Investigational Site — Sydney, New South Wales, Australia
• LEO Pharma Investigational Site — Woolloongabba, Queensland, Australia
• LEO Pharma Investigational Site — Carlton, Victoria, Australia
• LEO Pharma Investigational Site — Clayton, Victoria, Australia
• LEO Pharma Investigational Site — Calgary, Alberta, Canada
• LEO Pharma Investigational Site — Calgary, Alberta, Canada
• LEO Pharma Investigational Site — Edmonton, Alberta, Canada
• LEO Pharma Investigational Site — Markham, Ontario, Canada
• LEO Pharma Investigational Site — Mississauga, Ontario, Canada
• LEO Pharma Investigational Site — Niagara Falls, Ontario, Canada
• LEO Pharma Investigational site — Québec, Quebec, Canada
• LEO Pharma Investigational Site — Saint-Jérôme, Quebec, Canada
• LEO Pharma Investigational Site — Karlovy Vary, Czechia
• LEO Pharma Investigational Site — Kutná Hora, Czechia
• LEO Pharma Investigational Site — Nový Jičín, Czechia
• LEO Pharma Investigational Site — Ostrava-Poruba, Czechia
• LEO Pharma Investigational Site — Prague, Czechia

Full record on ClinicalTrials.gov

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