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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Application of 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion criteria (patients):

  • Moderate to severe AD
  • EASI < 50
  • 18-65 years old
  • Subject is capable of giving informed consent
  • Signed informed consent

Inclusion criteria (Healthy controls):

• No diagnosis or history of atopic dermatitis
• 18-65 years old
• Subject is capable of giving informed consent
• Signed informed consent

Exclusion Criteria:

• Use of systemic corticosteroids or systemic immunosuppressive/immunomodulating drugs within four weeks prior to start of the study
• Use of tanning beds or phototherapy within 6 weeks prior to start of the study
• History of cancer except for treated basal cell or spinal cell carcinoma of the skin
• Active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
• Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy arm; Healthy controls
Active Comparator: Tralokinumab; Patients with AD	Drug: Application of Tralokinumab; 2 Arms 20 patients 5 healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Tralokinumab in lesional skin after 16 weeks of treatment	Concentration 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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome analysed by SCORAD	Clinical response analysed by SCORAD (SCORing Atopic Dermatitis, 0-103, higher scores worse outcome)	2 years
Clinical outcome analysed by IGA	Clinical response analysed by IGA (Investigator Global Assessment, 0-4, higher scores worse outcome)	2 years
Clinical outcome analysed by DLQI	Clinical response analysed by DLQI (Dermatology Life Quality Index, 0-30, higher scores wose outcome	2 years
Clinical outcome analysed by worst daily pruritus NRS	Clinical response analysed by worst daily pruritus NRS Numerating Rating Scale, 0-10, higher values worse outcome)	2 years
Detection and quantification of Tralokinumab levels in skin biopsies	Detection and quantification of Tralokinumab levels in skin biopsies using mass spectrometer-based proteomics	2 years
Detection and quantification of Tralokinumab levels in skin swabs	Detection and quantification of Tralokinumab levels in skin swabs using mass spectrometer-based proteomics.	2 years
Immunologic changes on a cellular level in the skin	Immunologic changes on a cellular level in the skin (assessed by IMC and mass spectrometer-based proteomics) in correlation with Tralokinumab levels over the treatment course	2.5 years
Immunologic changes on a molecular level in the skin	Immunologic changes on molecular level in the skin (assessed by IMC and mass spectrometer-based proteomics) in correlation with Tralokinumab levels over the treatment course.	2.5 years
Immunologic changes on a cellular and molecular level in the blood	Immunologic changes on a cellular level in the blood (OLINK targeted proteomics) in correlation with Tralokinumab levels over the treatment course.	2.5 years
Immunologic changes on a molecular level in the blood	Immunologic changes on a molecular level in the blood (OLINK targeted proteomics) in correlation with Tralokinumab levels over the treatment course.	2.5 years
Changes in skin impendance asessed by NeviSense	Changes in skin impedance (as per parameter for barrier changes)	2.5 years
Levels of IL-13 in blood serum	Levels of IL-13 in blood serum	2.5 years
Levels of IL-13 in skin biopsies	Levels of IL-13 in skin biopsies	2.5 years
Blood eosinophil counts	Eosinophil counts in peripheral blood; normal < 0.4 g/l	2 years
Levels of total serum IgE	Levels of total serum IgE (kU/l)	2 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Hochgebirgsklinik Davos-Wolfgang
• Investigators: Principal Investigator: Peter Schmid-Grendelmeier, Prof, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): March 4, 2025

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tralokinumab
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: TRALIS/TRALO-2260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No