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)

Phase 1

• Conditions: Atopic Dermatitis (AD); MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-004561-39-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br><br>;Primary end point(s): Primary endpoint<br>•Change in EASI from baseline to Week 16.<br>;Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoint<br>•Number of AEs from baseline to Week 16+3 days per subject.<br><br>;Timepoint(s) of evaluation of this end point: Week 16 + 3 days<br><br>Please refer to E.5.2 where the timepoint is specified beside each exploratory end point.