An Investigator-Initiated, Descriptive, Proof-of-Concept, Open-Label Pilot Study Focusing on Topical JAK Inhibition as a Novel Treatment of Cutaneous T-Cell Lymphoma

Condition studied

Cutaneous T-cell lymphoma (CTCL) Mycosis fungoides

Investigational medicinal product(s)

Eligibility

Primary endpoint

Skin response, assessed by change in modified Severity-Weighted Assessment Tool (mSWAT) score from baseline to end of treatment (Week 16)., Overall skin response category, defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), based on predefined mSWAT-based response criteria., Overall response rate (ORR), defined as the proportion of subjects achieving CR or PR

Endpoint detail

Change from baseline in patient-reported pruritus, assessed using a Numeric Rating Scale (NRS)., Change from baseline in skin-related quality of life, assessed using the Skindex-29 questionnaire., To assess the mechanistic effect of topical JAKi in patients with CTCL. We aim to perform digital spatial and transcriptomic profiling on skin biopsies (lesional and non-lesional skin), and TEWL analysis to detect changes in the skin barrier.