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

NCT05378698 | Terminated Phase 2 DMC

• 1 other identifier: TRALIS/TRALO-2260
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Tralokinumab

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (15)

• Clinical outcome analysed by SCORAD

  2 years

• Clinical outcome analysed by IGA

  2 years

• Clinical outcome analysed by DLQI

  2 years

• Clinical outcome analysed by worst daily pruritus NRS

  2 years

• Detection and quantification of Tralokinumab levels in skin biopsies

  2 years

Study Arms (2)

Healthy arm

NO INTERVENTION

Healthy controls

Tralokinumab

ACTIVE COMPARATOR

Patients with AD

Drug: Application of Tralokinumab

Interventions

Application of Tralokinumab DRUG

2 Arms 20 patients 5 healthy controls

Tralokinumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Hochgebirgsklinik Davos-Wolfgang: collaborator

Study Sites (1)

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

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Peter Schmid-Grendelmeier, Prof, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: May 18, 2022
• Study Start: June 15, 2022
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)