Status:
UNKNOWN
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Hochgebirgsklinik Davos-Wolfgang
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 ...
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 respons...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05378698
Start Date
June 1 2022
End Date
June 1 2025
Last Update
May 18 2022
Active Locations (1)
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1
Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich
Zurich, Switzerland, 8091