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NCT05117060

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

Completed Phase 2 Results posted Last updated 4 June 2024
What this trial tests

Phase 2 trial testing LEO 152020 tablet in Atopic Dermatitis in 216 participants. Completed in 26 July 2023.

Timeline
13 December 2021
Primary endpoint
20 July 2023
26 July 2023

Quick facts

Lead sponsorJW Pharmaceutical
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment216
Start date13 December 2021
Primary completion20 July 2023
Estimated completion26 July 2023
Sites45 locations across Japan, Germany, Poland, Canada, Australia, United States, Spain, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

JW Pharmaceutical — full company profile →

Who can join

18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in EASI From Baseline to Week 16 Primary · Week 0 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.

GroupValue95% CI
LEO 152020 - Dosing Regimen 1 (Higher Dose)-9.99-12.85 – -7.13
LEO 152020 - Dosing Regimen 2 (Middle Dose)-8.83-12.63 – -5.04
LEO 152020 - Dosing Regimen 3 (Lower Dose)-8.87-12.47 – -5.28
LEO 152020 - Placebo-9.11-11.88 – -6.35
Number of Adverse Events From Baseline to Week 16+3 Days Per Subject Secondary · Week 0 to Week 16+3 days

Only treatment-emergent adverse events will be reported for this outcome measure. An adverse event will be considered treatment emergent if occurring after the first dose of treatment (Week 0) and up until 3 days after the last dose of treatment (Week 16+3 days for a participant completing the 16-week treatment period).

GroupValue95% CI
LEO 152020 - Dosing Regimen 1 (Higher Dose)109
LEO 152020 - Dosing Regimen 2 (Middle Dose)67
LEO 152020 - Dosing Regimen 3 (Lower Dose)80
LEO 152020 - Placebo75

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 to Week 16+3 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LEO 152020 - Dosing Regimen 1 (Higher Dose)
Serious: 0/61 (0%)
Deaths: 0/61
LEO 152020 - Dosing Regimen 2 (Middle Dose)
Serious: 2/45 (4%)
Deaths: 0/45
LEO 152020 - Dosing Regimen 3 (Lower Dose)
Serious: 1/49 (2%)
Deaths: 0/49
LEO 152020 - Placebo
Serious: 0/61 (0%)
Deaths: 0/61

Serious adverse events (2 terms)

ReactionSystemLEO 152020 - Dosing Regime…LEO 152020 - Dosing Regime…LEO 152020 - Dosing Regime…LEO 152020 - Placebo
Eczema herpeticumInfections and infestations
Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Other adverse events (8 terms — click to expand)

ReactionSystemLEO 152020 - Dosing Regime…LEO 152020 - Dosing Regime…LEO 152020 - Dosing Regime…LEO 152020 - Placebo
Dermatitis atopicSkin and subcutaneous tissue disorders
NauseaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
COVID-19Infections and infestations
NasopharyngitisInfections and infestations
Electrocardiogram QT prolongedInvestigations
DiarrhoeaGastrointestinal disorders
HeadacheNervous system disorders

Most-reported serious reactions: Eczema herpeticum, Malignant melanoma in situ.

Data from ClinicalTrials.gov NCT05117060 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel Therapeutic Targets for the Treatment of Atopic Dermatitis.
    Tsuji G, Yamamura K, Kawamura K, Kido-Nakahara M, et al · · 2023 · cited 17× · PMID 37238974 · DOI 10.3390/biomedicines11051303
  2. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
    Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
  3. Advancing Therapeutic Strategies in Atopic Dermatitis: Emerging Targets and Personalized Approaches.
    Lo Y, Cheng TT, Huang CJ, Cheng YC, et al · · 2025 · cited 5× · PMID 40563478 · DOI 10.3390/biom15060838
  4. Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.
    Nitulescu G, Olaru OT, Andrei C, Nitulescu GM, et al · · 2025 · cited 2× · PMID 40864813 · DOI 10.3390/cimb47080659
  5. From neuroimmune circuits to targeted therapy of chronic pruritus.
    Ramcke T, Kaplan DH. · · 2026 · PMID 41831428 · DOI 10.1016/j.pharmr.2026.100121

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other JW Pharmaceutical trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05117060.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing