Study on the application of Ruxolitinib cream in patients with rash under anti-PD1 cancer therapy
Summary description of the study
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)
Intervention under investigation
Topical application of 1.5% INCB18424 (Ruxolitinib cream) twice daily on lesional skin over 12 weeks
(BASEC)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Zurich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contact
Contact Person Switzerland
Barbara Meier-Schiesser
+41-43-2539439
barbara.meier-schiesser@clutterusz.chUniversitätsspital Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
09.02.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Topical Ruxolitinib as a treatment of anti-PD1 induced lichenoid skin toxicities: a prospective single-center pilot study (BASEC)
Academic title
not available
Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available