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

Primary Purpose

Atopic Dermatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Application of Tralokinumab
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis focused on measuring Tralokinumab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Healthy arm

Tralokinumab

Arm Description

Healthy controls

Patients with AD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical outcome analysed by SCORAD
Clinical response analysed by SCORAD (SCORing Atopic Dermatitis, 0-103, higher scores worse outcome)
Clinical outcome analysed by IGA
Clinical response analysed by IGA (Investigator Global Assessment, 0-4, higher scores worse outcome)
Clinical outcome analysed by DLQI
Clinical response analysed by DLQI (Dermatology Life Quality Index, 0-30, higher scores wose outcome
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)
Detection and quantification of Tralokinumab levels in skin biopsies
Detection and quantification of Tralokinumab levels in skin biopsies using mass spectrometer-based proteomics
Detection and quantification of Tralokinumab levels in skin swabs
Detection and quantification of Tralokinumab levels in skin swabs using mass spectrometer-based proteomics.
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
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.
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.
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.
Changes in skin impendance asessed by NeviSense
Changes in skin impedance (as per parameter for barrier changes)
Levels of IL-13 in blood serum
Levels of IL-13 in blood serum
Levels of IL-13 in skin biopsies
Levels of IL-13 in skin biopsies
Blood eosinophil counts
Eosinophil counts in peripheral blood; normal < 0.4 g/l
Levels of total serum IgE
Levels of total serum IgE (kU/l)

Full Information

First Posted
February 17, 2022
Last Updated
May 13, 2022
Sponsor
University of Zurich
Collaborators
Hochgebirgsklinik Davos-Wolfgang
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1. Study Identification

Unique Protocol Identification Number
NCT05378698
Brief Title
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation
Acronym
TRALIS
Official Title
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (TRALIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Hochgebirgsklinik Davos-Wolfgang

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Tralokinumab

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-randomized treatment study involving state of the art technique such as imaging mass spectrometry, classical mass spectroscopy and proteomics in patients treated with Tralokinumab during 16 weeks
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy arm
Arm Type
No Intervention
Arm Description
Healthy controls
Arm Title
Tralokinumab
Arm Type
Active Comparator
Arm Description
Patients with AD
Intervention Type
Drug
Intervention Name(s)
Application of Tralokinumab
Intervention Description
2 Arms 20 patients 5 healthy controls
Primary Outcome Measure Information:
Title
Concentration of Tralokinumab in lesional skin after 16 weeks of treatment
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Clinical outcome analysed by SCORAD
Description
Clinical response analysed by SCORAD (SCORing Atopic Dermatitis, 0-103, higher scores worse outcome)
Time Frame
2 years
Title
Clinical outcome analysed by IGA
Description
Clinical response analysed by IGA (Investigator Global Assessment, 0-4, higher scores worse outcome)
Time Frame
2 years
Title
Clinical outcome analysed by DLQI
Description
Clinical response analysed by DLQI (Dermatology Life Quality Index, 0-30, higher scores wose outcome
Time Frame
2 years
Title
Clinical outcome analysed by worst daily pruritus NRS
Description
Clinical response analysed by worst daily pruritus NRS Numerating Rating Scale, 0-10, higher values worse outcome)
Time Frame
2 years
Title
Detection and quantification of Tralokinumab levels in skin biopsies
Description
Detection and quantification of Tralokinumab levels in skin biopsies using mass spectrometer-based proteomics
Time Frame
2 years
Title
Detection and quantification of Tralokinumab levels in skin swabs
Description
Detection and quantification of Tralokinumab levels in skin swabs using mass spectrometer-based proteomics.
Time Frame
2 years
Title
Immunologic changes on a cellular level in the skin
Description
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
Time Frame
2.5 years
Title
Immunologic changes on a molecular level in the skin
Description
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.
Time Frame
2.5 years
Title
Immunologic changes on a cellular and molecular level in the blood
Description
Immunologic changes on a cellular level in the blood (OLINK targeted proteomics) in correlation with Tralokinumab levels over the treatment course.
Time Frame
2.5 years
Title
Immunologic changes on a molecular level in the blood
Description
Immunologic changes on a molecular level in the blood (OLINK targeted proteomics) in correlation with Tralokinumab levels over the treatment course.
Time Frame
2.5 years
Title
Changes in skin impendance asessed by NeviSense
Description
Changes in skin impedance (as per parameter for barrier changes)
Time Frame
2.5 years
Title
Levels of IL-13 in blood serum
Description
Levels of IL-13 in blood serum
Time Frame
2.5 years
Title
Levels of IL-13 in skin biopsies
Description
Levels of IL-13 in skin biopsies
Time Frame
2.5 years
Title
Blood eosinophil counts
Description
Eosinophil counts in peripheral blood; normal < 0.4 g/l
Time Frame
2 years
Title
Levels of total serum IgE
Description
Levels of total serum IgE (kU/l)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Schmid-Grendelmeier, Prof,MD
Phone
+41442553079
Email
peter.schmid@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schmid-Grendelmeier, Prof, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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