drugset / Trial / NCT05470114

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

NCT05470114

Phase 2 Completed 13 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-05-19
Primary completion
2023-06-07
Completion
2023-10-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody Subcutaneous
Subject TEMTOKIBART Protein / enzyme biologic Subcutaneous

Indications