NCT05470114

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD

A Randomized, Double-blinded, Active Comparator-controlled, 16-week, Single-site, Exploratory, Mechanistic Trial to Assess the Effect of LEO 138559 on the Molecular Signature and Safety in Adults With Moderate to Severe Atopic Dermatitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection. The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®. The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LEO 138559	LEO 138559 is an antibody given by subcutaneous injection.
DRUG	Dupixent®	Dupixent® is an antibody given by subcutaneous injection.

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-06-07
• Completion: 2023-10-09
• First posted: 2022-07-22
• Last updated: 2025-03-11
• Results posted: 2025-02-14

Locations

1 site across 1 country: Austria