NCT05378698

Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation

Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (TRALIS)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The clinical efficacy of tralokinumab has been demonstrated in the treatment of AD; its MOA however remains insufficiently understood. A better understanding of the mechanisms underlying the clinical effects of tralokinumab would be of great clinical benefit since it may ultimately help us to identify more precisely candidate patients who may benefit from a therapy with tralokinumab.

Detailed description

Primary objective: To detect and quantify Tralokinumab in the skin of treated AD patients and concurrently characterize the cellular and molecular changes of the cutaneous and systemic immune response Secondary objectives: * Clinical response analysed by SCORAD, IG, DLQI and worst daily pruritus NRS * To identify immunologic changes on a cellular and molecular level in the skin and in the blood in correlation with Tralokinumab levels over the treatment course. * Changes in the skin barrier function over the treatment course Primary outcome: Detection of Tralokinumab in lesional skin after 16 weeks of treatment in comparison to the begin of the study assessed by mass spectrometry with Parallel Reaction Monitoring (PRM) using the Orbitrap ECLIPSE mass spectrometer Secondary outcome: * Clinical response analysed by SCORAD, IG, DLQI and worst daily pruritus NRS * Detection and quantification of Tralokinumab levels in skin biopsies and skin swabs using mass spectrometer-based proteomics. * Immunologic changes on a cellular and molecular level in the skin (assessed by IMC and mass spectrometer-based proteomics) and in the blood (OLINK targeted proteomics) in correlation with Tralokinumab levels over the treatment course. * Changes in skin impedance (as a parameter for barrier changes) measured by NeviSense * Levels of free IL-13 in blood serum and in skin biopsies * Levels of serum IgE (total, specific) * Blood eosinophil counts

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Application of Tralokinumab	2 Arms 20 patients 5 healthy controls

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2022-05-18
• Last updated: 2026-02-06

Locations

1 site across 1 country: Switzerland