Topical JAK-Inhibition of Early-Stage CTCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
delgocitinib
DrugDelgocitinib 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: DelgocitinibExperimental treatment 1 intervention
Trial outcomes
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
Time frame
From baseline (day 0) to end of treatment week 16 (day 112)Secondary outcomes
1
Overall Response Rate (mSWAT)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD), based on clinical and molecular assessment using the modified Severity-Weighted Assessment Tool (mSWAT). The mSWAT is a clinician-assessed measure of skin disease burden calculated from body surface area (BSA) affected by patches, plaques, and tumors, weighted by lesion type (patch ×1, plaque ×2, tumor ×4). Scores range from 0 (no skin involvement) to a theoretical maximum of 400 (100% BSA, all tumor), with higher scores indicating more extensive/severe skin disease (worse outcome)
Time frame
From baseline (day 0) to end of treatment (day 112)2
Change in Patient-Reported Pruritus (NRS)
Change from baseline in pruritus intensity, assessed using the Numeric Rating Scale (NRS), a patient-reported single-item scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity (worse outcome).
Time frame
From baseline (day 0) to end of treatment, week 16 (day 112)3
Change in Skin-Related Quality of Life (Skindex-29)
Change from baseline in skin-related quality of life, assessed using the Skindex-29, a 29-item dermatology-specific quality-of-life questionnaire covering three domains (symptoms, emotions, and functioning). Each domain score is standardized to a 0-100 scale, where 0 indicates no impact on quality of life and 100 indicates maximum negative impact, with higher scores indicating worse skin-related quality of life.
Time frame
From baseline (day 0) to end of treatment, week 16 (day 112)4
Change in Immune Cell Infiltrate Density by Immunohistochemistry
Change from baseline in density of immune cell markers, including malignant T-cell markers, in lesional and non-lesional skin biopsies, assessed by immunohistochemistry (IHC). Reported as cells per mm² and/or percentage of positively stained area.
Time frame
From baseline (day 0) to end of treatment, week 16 (day 112)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Collaborator
Johannes Kepler University of Linz
Collaborator
LEO Foundation
Collaborator
Source ClinicalTrials.gov
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