Efficacy and safety of different dose regimens of LEO 152020 tablets for the treatment of adults with moderate to severe atopic dermatitis up to 16 weeks

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-CZ
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult, age 18 years or older at baseline.
2. Diagnosis of chronic AD as defined by the Hanifin and Rajka (1980) criteria for AD (36).
3. History of AD =1 year prior to baseline.
4. 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.
5.7.1= EASI =50 at baseline.
6.vIGA AD score =3 at baseline.
7.BSA =5% 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

1.Previous treatment with an oral H4R antagonist (including LEO 152020) within 6 months prior to baseline.
2.Previous treatment with 3 or more systemic AD treatments prior to screening.
3.Women who are pregnant or lactating.

Study & Design

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