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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523472-23-01
Enrollment
15
Registered
2026-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-cell lymphoma (CTCL) Mycosis fungoides

Brief summary

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

Detailed description

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.

Interventions

DRUGAnzupgo 20 mg/g cream

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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.—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 11, 2026