Study on the application of Ruxolitinib cream in patients with rash under anti-PD1 cancer therapy
Zusammenfassung der Studie
Rash under tumor treatment with immunotherapy (anti-PD1 antibody therapy) is a common side effect. When such a skin reaction occurs, patients typically suffer from a rash on the chest, back, and extremities. The skin reaction is usually treated with cortisone as a cream or tablet. There is already research on humans regarding the skin reaction under anti-PD1 antibody therapy. Previous studies in humans have shown that certain inflammatory markers are elevated. We also know that the study medication may help reduce these inflammatory markers. However, we do not yet have data on whether the study medication can actually reduce inflammation in the skin in cases of rash under anti-PD1 antibody therapy. Therefore, we are investigating in this study whether the study medication is effective and well tolerated in cases of rash under anti-PD1 antibody therapy. The study medication contains the active ingredient Ruxolitinib and is applied as a cream. The study medication is approved for other skin diseases (vitiligo and atopic eczema) in the USA and in EU countries, respectively only in the USA. Approval in Switzerland is still pending. Only when the efficacy of the study medication against rashes under anti-PD1 antibody therapy is scientifically investigated and proven can it be approved in Switzerland and used as a treatment. In our study, participants will not be divided into groups. Each study patient will receive the investigational substance.
(BASEC)
Untersuchte Intervention
Topical application of 1.5% INCB18424 (Ruxolitinib cream) twice daily on lesional skin over 12 weeks
(BASEC)
Untersuchte Krankheit(en)
Lichenoid rashes under anti-PD1 tumor therapy
(BASEC)
- Indication: lichenoid rash that developed under / after anti-PD-1 therapy - Male and female patients aged ≥18 years - The participant has been informed and has given their consent to the IRB/IEC approved informed consent form (BASEC)
Ausschlusskriterien
- Patient with other skin diseases resembling lichenoid rashes under anti-PD-1 therapy - Pregnant or breastfeeding women - Topical glucocorticoids, topical calcineurin inhibitors, UV light therapy, therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine are not allowed during the study or in the 8 weeks prior to the start of the study (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Barbara Meier-Schiesser
+41-43-2539439
barbara.meier-schiesser@clutterusz.chUniversitätsspital Zürich
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.02.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Topical Ruxolitinib as a treatment of anti-PD1 induced lichenoid skin toxicities: a prospective single-center pilot study (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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