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Atopic DermatitisPhase 2/3TRALISNCT05378698

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

A Phase 2/3 study testing Application of Tralokinumab in people with Atopic Dermatitis, run by University of Zurich at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Application of Tralokinumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSwitzerland
Study dates
15 Jun 2022to 4 Mar 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Moderate to severe AD
  • EASI < 50
  • 18-65 years old
  • Subject is capable of giving informed consent
  • Signed informed consent
  • No diagnosis or history of atopic dermatitis
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  • 18-65 years old
  • Subject is capable of giving informed consent
  • Signed informed consent

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Read the 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
Being tested
Application of Tralokinumab
Keywords
Tralokinumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application of TralokinumabDrug

    2 Arms 20 patients 5 healthy controls

Study groups in NCT05378698
Study groupRoleWhat they receive
Healthy armNo interventionHealthy controls
TralokinumabActive comparatorPatients with AD
Receives: Drug: Application of Tralokinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (15)

  1. Clinical outcome analysed by SCORAD

    Clinical response analysed by SCORAD (SCORing Atopic Dermatitis, 0-103, higher scores worse outcome)

    Measured: 2 years

  2. Clinical outcome analysed by IGA

    Clinical response analysed by IGA (Investigator Global Assessment, 0-4, higher scores worse outcome)

    Measured: 2 years

  3. Clinical outcome analysed by DLQI

    Clinical response analysed by DLQI (Dermatology Life Quality Index, 0-30, higher scores wose outcome

    Measured: 2 years

  4. 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)

    Measured: 2 years

  5. Detection and quantification of Tralokinumab levels in skin biopsies

    Detection and quantification of Tralokinumab levels in skin biopsies using mass spectrometer-based proteomics

    Measured: 2 years

  6. Detection and quantification of Tralokinumab levels in skin swabs

    Detection and quantification of Tralokinumab levels in skin swabs using mass spectrometer-based proteomics.

    Measured: 2 years

  7. 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

    Measured: 2.5 years

  8. 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.

    Measured: 2.5 years

  9. 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.

    Measured: 2.5 years

  10. 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.

    Measured: 2.5 years

  11. Changes in skin impendance asessed by NeviSense

    Changes in skin impedance (as per parameter for barrier changes)

    Measured: 2.5 years

  12. Levels of IL-13 in blood serum

    Levels of IL-13 in blood serum

    Measured: 2.5 years

  13. Levels of IL-13 in skin biopsies

    Levels of IL-13 in skin biopsies

    Measured: 2.5 years

  14. Blood eosinophil counts

    Eosinophil counts in peripheral blood; normal < 0.4 g/l

    Measured: 2 years

  15. Levels of total serum IgE

    Levels of total serum IgE (kU/l)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start15 Jun 2022
  3. Primary completion4 Mar 2025
  4. Study completion4 Mar 2025

Why it stopped: treatment group completed but insufficient recruitment control group

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378698
Sponsor's protocol ID
TRALIS/TRALO-2260
Acronym
TRALIS
Status last verified
Feb 2026
First submitted
17 Feb 2022
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Application of Tralokinumab in people with Atopic Dermatitis, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: treatment group completed but insufficient recruitment control group). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Tralokinumab in lesional skin after 16 weeks of treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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