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

Atopic Dermatitis Clinical Trial

— TRALIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05378698
• Other study ID #: TRALIS/TRALO-2260
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: Peter Schmid-Grendelmeier, Prof,MD
• Phone: +41442553079
• Email: peter.schmid[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Application of Tralokinumab
2 Arms 20 patients 5 healthy controls

Locations

Country	Name	City	State
Switzerland	Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Hochgebirgsklinik Davos-Wolfgang

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical outcome analysed by SCORAD	Clinical response analysed by SCORAD (SCORing Atopic Dermatitis, 0-103, higher scores worse outcome)	2 years
Secondary	Clinical outcome analysed by IGA	Clinical response analysed by IGA (Investigator Global Assessment, 0-4, higher scores worse outcome)	2 years
Secondary	Clinical outcome analysed by DLQI	Clinical response analysed by DLQI (Dermatology Life Quality Index, 0-30, higher scores wose outcome	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in skin impendance asessed by NeviSense	Changes in skin impedance (as per parameter for barrier changes)	2.5 years
Secondary	Levels of IL-13 in blood serum	Levels of IL-13 in blood serum	2.5 years
Secondary	Levels of IL-13 in skin biopsies	Levels of IL-13 in skin biopsies	2.5 years
Secondary	Blood eosinophil counts	Eosinophil counts in peripheral blood; normal < 0.4 g/l	2 years
Secondary	Levels of total serum IgE	Levels of total serum IgE (kU/l)	2 years