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

JW Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: LEO 152020 placebo tablet; Drug: LEO 152020 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05117060

2020-004561-39 (EudraCT Number)

LP0190-1488

U1111-1281-1895 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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216 participants in 4 patient groups, including a placebo group

LEO 152020 tablet - Dose regimen 1

Experimental group

Description:

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Treatment:

Drug: LEO 152020 tablet

LEO 152020 tablet - Dose regimen 2

Experimental group

Description:

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Treatment:

Drug: LEO 152020 tablet

Drug: LEO 152020 placebo tablet

LEO 152020 tablet - Dose regimen 3

Experimental group

Description:

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Treatment:

Drug: LEO 152020 tablet

Drug: LEO 152020 placebo tablet

LEO 152020 placebo tablet

Placebo Comparator group

Description:

Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Treatment:

Drug: LEO 152020 placebo tablet