CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
LEO 138559 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05470114
NCT05470114Phase 2Completed

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.

LEO Pharma·interventional·Posted Jul 22, 2022·Updated Mar 11, 2025

In Brief

A Phase 2 clinical trial evaluating LEO 138559 and Dupixent® for Atopic Dermatitis. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 22, 2022
Enrollment StartMay 19, 2022
Primary CompletionJun 7, 2023
Study CompletionOct 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.9 years ago

Interventions

LEO 138559drug

LEO 138559 is an antibody given by subcutaneous injection.

Dupixent®drug

Dupixent® is an antibody given by subcutaneous injection.