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Topical JAK-Inhibition of Early-Stage CTCL

NCT07781449 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-26

No results posted yet for this study

Summary

This study tests whether a cream named delgocitinib (Anzupgo), applied twice daily to the skin, is safe and well tolerated in people with early-stage cutaneous T-cell lymphoma (a rare type of skin cancer called mycosis fungoides). The cream works by blocking proteins called JAK enzymes, which are involved in inflammation and cancer cell growth in the skin.

Delgocitinib cream is already approved for treating chronic hand eczema, but it has not yet been studied in people with cutaneous T-cell lymphoma. In this study, up to 15 participants with stable, early-stage disease will apply the cream to their affected skin for 16 weeks. Researchers will closely monitor for side effects and also look at whether the cream improves skin symptoms, such as itching and the appearance of the skin. Participants will be followed for 4 additional weeks after treatment ends.

This is an early, exploratory study (a "proof-of-concept" trial) designed mainly to check safety, not to prove that the treatment works. The findings will help researchers decide whether to test this cream in larger studies in the future.

Conditions

  • Mycosis Fungoides
  • Cutaneous T-cell Lymphoma

Interventions

DRUG

delgocitinib

Delgocitinib is a pan-Janus kinase (JAK1, JAK2, JAK3, TYK2) inhibitor formulated as a 20 mg/g topical cream, marketed as Anzupgo and approved by the European Medicines Agency for chronic hand eczema. In this study, delgocitinib cream is applied topically to affected skin areas twice daily for 16 weeks, off-label, for the treatment of early-stage cutaneous T-cell lymphoma.

Sponsors & Collaborators

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark

    collaborator OTHER

  • Johannes Kepler University of Linz

    collaborator OTHER

  • LEO Foundation

    collaborator UNKNOWN

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Rikke Bech, MD, PhD · Department of Dermatology and Venerology, Aarhus University Hospital

  • Elisabeth Linde Grove, MD · Department of Dermatology and Venerology, Aarhus University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-06-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781449 on ClinicalTrials.gov