NCT05117060|CompletedPhase 2ResultsDMCFDA Drug

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

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

JW Pharmaceutical ClinicalTrials.gov

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3 other identifiers

LP0190-14882020-004561-39U1111-1281-1895

Study Type

interventional

Target

216

Locations

8 countries

Sites

Timeline

RegisteredNov 2021

StartedDec 2021

CompletionJul 2023

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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

216

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2021

Geographic Reach

8 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

November 8, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed

6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed

10 months until next milestone

Results Posted

Study results publicly available

May 31, 2024

Completed

Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

November 8, 2021

Results QC Date

April 10, 2024

Last Update Submit

June 2, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

Change in EASI From Baseline 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.
Week 0 to Week 16

Secondary Outcomes (1)

Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
Week 0 to Week 16+3 days

Study Arms (4)

LEO 152020 tablet - Dose regimen 1

EXPERIMENTAL

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

Drug: LEO 152020 tablet

LEO 152020 tablet - Dose regimen 2

EXPERIMENTAL

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

Drug: LEO 152020 tabletDrug: LEO 152020 placebo tablet

LEO 152020 tablet - Dose regimen 3

EXPERIMENTAL

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

Drug: LEO 152020 tabletDrug: LEO 152020 placebo tablet

LEO 152020 placebo tablet

PLACEBO COMPARATOR

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

Drug: LEO 152020 placebo tablet

Interventions

LEO 152020 tabletDRUG

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.

LEO 152020 tablet - Dose regimen 1LEO 152020 tablet - Dose regimen 2LEO 152020 tablet - Dose regimen 3

LEO 152020 placebo tabletDRUG

LEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.

LEO 152020 placebo tabletLEO 152020 tablet - Dose regimen 2LEO 152020 tablet - Dose regimen 3

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.
≤ 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.

Contact the study team to confirm eligibility.