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 (eczema)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004561-39-PL

Enrollment

224

Registered

2021-05-27

Start date

2021-07-13

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis (AD) MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Interventions

Product Name: LEO 152020 film-coated tablet (50 mg) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not applicable at this stage CAS Number: 1429375-85-8 Current Sponsor code: LEO 152020B

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must fulfil all of the following criteria to be eligible for the trial: • 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= EASI =50 at baseline • vIGA AD score =3 at baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 214 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Subjects are not eligible for the trial if they violate any of the following criteria: • Previous treatment with an oral 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 or lactating.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the exposure response relationship of LEO 152020 and evaluate efficacy of LEO 152020 compared with placebo for up to 16 weeks of treatment in subjects with moderate to severe AD;Secondary Objective: To evaluate the safety of LEO 152020 compared with placebo in subjects with moderate to severe AD ;Primary end point(s): Primary endpoint •Change in EASI from baseline to Week 16. ;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: To explore the exposure response relationship of LEO 152020 and evaluate efficacy of LEO 152020 compared with placebo for up to 16 weeks of treatment in subjects with moderate to severe AD;Secondary Objective: To evaluate the safety of LEO 152020 compared with placebo in subjects with moderate to severe AD ;Primary end point(s): Primary endpoint •Change in EASI from baseline to Week 16. ;Timepoint(s) of evaluation of this end point: Week 16

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints • Number of AEs b from baseline to Week 16+3 days per subject. ;Timepoint(s) of evaluation of this end point: Week 16 + 3 days Please refer to E.5.2 where the timepoint is specified beside end point.	—

Countries

Australia, Canada, Czechia, Czech Republic, Germany, Japan, Poland, Spain, United States

Contacts

Public ContactGlobal Regulatory Affairs

LEO Pharma A/S

raleodk@leo-pharma.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026