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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Zurich
• Collaborator: Hochgebirgsklinik Davos-Wolfgang

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