Topical JAK-Inhibition of Early-Stage CTCL

NCT07781449 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 2025-523472-23-012025
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

JAK inhibitor; Delgocitinib; Anzupgo; Early-stage mycosis fungoides; Cutaneous T-cell Lymphoma; Pan-JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Safety and Tolerability of Topical Delgocitinib]

  Severity and causal relationship to study treatment will be assessed for all TEAEs and SAEs. Local tolerability will be evaluated based on application-site reactions. Vital signs, physical examination findings, and laboratory parameters will be assessed for clinically relevant abnormalities

  From baseline (day 0) to end of treatment week 16 (day 112)

Secondary Outcomes (7)

• Overall Response Rate (mSWAT)

  From baseline (day 0) to end of treatment (day 112)

• Change in Patient-Reported Pruritus (NRS)

  From baseline (day 0) to end of treatment, week 16 (day 112)

• Change in Skin-Related Quality of Life (Skindex-29)

  From baseline (day 0) to end of treatment, week 16 (day 112)

• Change in Immune Cell Infiltrate Density by Immunohistochemistry

  From baseline (day 0) to end of treatment, week 16 (day 112)

• Change in Spatial Gene and Protein Expression Profile by Spatial Transcriptomics

  From baseline (day 0) to end of treatment, week 16 (day 112)

Study Arms (1)

Delgocitinib

EXPERIMENTAL

Participants apply delgocitinib 20 mg/g cream (Anzupgo) topically to affected skin areas twice daily for 16 weeks.

Drug: delgocitinib

Interventions

delgocitinib DRUG

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.

Also known as: Anzupgo

Delgocitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 or older at the time of consent
• Histologically confirmed diagnosis of mycosis fungoides (stage IA, IB, or IIA)
• Stable disease requiring palliative treatment
• No change in medication for 2 months prior to study entry
• Willing and able to give informed consent, obtained prior to any study-related procedures

You may not qualify if:

• Hypersensitivity to the active substance or to any of the excipients (Benzyl alcohol, Butylhydroxyanisole, Cetostearyl alcohol)
• Sézary syndrome (cancerous T-cells found in the blood)
• Concomitant treatment with other topical/skin-directed therapies (phototherapy, radiotherapy, chlormethine gel, topical corticosteroids)
• Psychiatric illness, disability, or social situation that would compromise subject safety or ability to provide consent
• History of non-melanoma skin cancer (NMSC)
• Atopic dermatitis or other clinically relevant dermatological diseases
• Other clinically significant medical conditions, including:
• Ongoing skin infections requiring antibiotics
• Physical, laboratory, or vital sign abnormalities that would, in the investigator's opinion, put the subject at undue risk or interfere with interpretation of study results
• Pregnancy or breastfeeding
• Women of childbearing potential must use a highly effective contraceptive method

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Johannes Kepler University of Linz: collaborator
• LEO Foundation: collaborator
• GCP-unit at Aarhus University Hospital, Aarhus, Denmark: collaborator

Related Publications (32)

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Related Links

• Heads of Medicines Agencies - Clinical Trials Coordination Group. Recommendations related to contraception and pregnancy testing in clinical trials. Version 1.2. HMA; 2024

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous

Interventions

delgocitinib

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rikke Bech, MD, PhD

  Department of Dermatology and Venerology, Aarhus University Hospital

  STUDY DIRECTOR

• Elisabeth Linde Grove, MD

  Department of Dermatology and Venerology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Linde Grove, MD

CONTACT

+45 42484614; au553240@uni.au.dk

Rikke Bech, MD, PhD

CONTACT

+45 24 94 62 40; Rikke.Bech@aarhus.rm.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD-student

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 26, 2026

Record last verified: 2026-08