EFFECTS OF TRALOKINUMAB ON THE SKIN: AN IMMUNOLOGICAL AND MOLECULAR STUDY
Zusammenfassung der Studie
Tralokinumab is a new medication for the treatment of atopic dermatitis. It is used for moderate to severe atopic dermatitis. It is injected under the skin every two weeks. In Switzerland, it has been approved for the treatment of atopic dermatitis since February 2022. In large studies involving over 1500 patients, it has already been shown that Tralokinumab is effective against atopic dermatitis and well tolerated. However, little is known about where exactly in the skin the medication acts. This may be important to know which patients can particularly benefit from the treatment. Additionally, it could help to better understand the disease itself. Therefore, we want to investigate how much of the medication can be detected in the skin. Furthermore, we want to know what changes occur in the skin under the treatment. We will examine both skin cells and certain signaling substances in the skin and blood. Study participants will receive Tralokinumab for 16 weeks. After four and 16 weeks, we will assess how well the atopic dermatitis has responded to the treatment. Additionally, blood and skin samples will be taken. For control, we also want to include 5 healthy subjects. For these, only the skin will be examined and skin and blood samples will be taken. The control subjects will not receive any medication.
(BASEC)
Untersuchte Intervention
Treatment with Tralokinumab according to manufacturer instructions for 16 weeks.
(BASEC)
Untersuchte Krankheit(en)
Atopic dermatitis
(BASEC)
- Moderate to severe atopic dermatitis (SCORAD > 25) (treatment group) - or: no history or current presence of atopic dermatitis (control group) - Age 18-65 years (BASEC)
Ausschlusskriterien
- Treatment of atopic dermatitis with systemic glucocorticoids, immunosuppressants/immunomodulatory therapies, or phototherapy 6 weeks prior to the start of the study, vaccination with live vaccines up to 6 weeks before study start - Active or chronic infectious disease (viral including HBV, HCV, HIV, bacterial including Tb, fungi, worms, parasites) - Pregnancy or breastfeeding (BASEC)
Studienstandort
Zürich, Andere
(BASEC)
Hochgebirgsklinik Davos, Davos Wolfgang
(BASEC)
Sponsor
Prof. Dr. med. Peter Schmid-Grendelmeier, Allergiestation, Dermatologische Klinik, Universitätsspital Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Peter Schmid-Grendelmeier
+41 44 255 30 79
peter.schmid@clutterusz.chAllergiestation, Dermatologische Klinik, Universitätsspital Zürich
(BASEC)
Allgemeine Auskünfte
University of Zurich
(ICTRP)
Allgemeine Auskünfte
University of Zurich
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.09.2022
(BASEC)
ICTRP Studien-ID
NCT05378698 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Effects of Tralokinumab in the Skin: An Immunologic and Molecular Investigation (BASEC)
Wissenschaftlicher Titel
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (TRALIS) (ICTRP)
Öffentlicher Titel
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (ICTRP)
Untersuchte Krankheit(en)
Atopic Dermatitis (ICTRP)
Untersuchte Intervention
Drug: Application of Tralokinumab (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Concentration of Tralokinumab in lesional skin after 16 weeks of treatment (ICTRP)
Clinical outcome analysed by SCORAD;Clinical outcome analysed by IGA;Clinical outcome analysed by DLQI;Clinical outcome analysed by worst daily pruritus NRS;Detection and quantification of Tralokinumab levels in skin biopsies;Detection and quantification of Tralokinumab levels in skin swabs;Immunologic changes on a cellular level in the skin;Immunologic changes on a molecular level in the skin;Immunologic changes on a cellular and molecular level in the blood;Immunologic changes on a molecular level in the blood;Changes in skin impendance asessed by NeviSense;Levels of IL-13 in blood serum;Levels of IL-13 in skin biopsies;Blood eosinophil counts;Levels of total serum IgE (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Hochgebirgsklinik Davos-Wolfgang (ICTRP)
Weitere Kontakte
Peter Schmid-Grendelmeier, Prof, MD, University of Zurich (ICTRP)
Sekundäre IDs
TRALIS/TRALO-2260 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05378698 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
tralis-lay-summary-2026-03-06.pdfLink zu den Ergebnissen im Primärregister
nicht verfügbar