A Phase 2 interventional study of delgocitinib in Mycosis Fungoides and Cutaneous T-cell Lymphoma, sponsored by Aarhus University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Aarhus University Hospital · Phase 2, Interventional, and Treatment
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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.
This is an investigator-initiated, descriptive, proof-of-concept, open-label, single-arm phase II pilot study evaluating topical Janus kinase (JAK) inhibition with delgocitinib 20 mg/g cream (Anzupgo) in adults with stable, early-stage mycosis fungoides (MF stage IA, IB, or IIA), the most common subtype of cutaneous T-cell lymphoma (CTCL).
CTCL is a rare, incurable malignancy of unknown etiology. Dysregulated JAK/STAT signaling has repeatedly been linked to malignant T-cell proliferation, drug resistance, and skin barrier deterioration in CTCL. Delgocitinib is a pan-JAK inhibitor (JAK1, JAK2, JAK3, TYK2) already approved by the European Medicines Agency for chronic hand eczema, with a well-characterized local safety profile and minimal systemic absorption following topical application. This study investigates its off-label use in CTCL.
Approximately 15 participants will complete an up-to 4-week screening phase, a 16-week treatment phase with delgocitinib applied topically twice daily to affected skin areas, and a 4-week observational follow-up phase, for a total study duration of approximately 24 weeks per participant.
The primary objective is to evaluate the safety and tolerability of topical delgocitinib in this population, including incidence, severity, and causality of treatment-emergent adverse events and serious adverse events, local tolerability, and clinically relevant laboratory or vital sign abnormalities.
The secondary objective is to explore preliminary evidence of clinical activity and biological effects, including overall response rate. Exploratory mechanistic analyses will be performed on lesional and non-lesional skin biopsies to characterize malignant T-cell populations, the tumor microenvironment, and skin barrier changes in response to treatment.
There is no safety monitoring committee due to the small sample size; a certified dermatologist will monitor all adverse events, vital signs, and physical examination findings throughout the study. The study will be discontinued if more than three participants experience unacceptable adverse effects judged related to delgocitinib, or if more than seven participants experience disease progression requiring alternative therapy.
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
This study's planned enrollment of 15 is below the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.
Browse Mycosis Fungoides studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants apply delgocitinib 20 mg/g cream (Anzupgo) topically to affected skin areas twice daily for 16 weeks.
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.
Also known as: Anzupgo
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)
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)
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)
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)
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)
Change in Spatial Gene and Protein Expression Profile by Spatial Transcriptomics
Change from baseline in spatially resolved gene and protein expression in lesional and non-lesional skin biopsies, assessed by spatial transcriptomics platforms (Nanostring GeoMx digital spatial profiling and 10x Genomics Xenium in situ analysis), used to characterize the tumor microenvironment and skin barrier gene expression changes. Reported as normalized expression counts per region of interest.
Time frame: From baseline (day 0) to end of treatment, week 16 (day 112)
Change in Immune Cell Composition by Imaging Mass Cytometry
Change from baseline in single-cell protein marker expression and immune cell subset composition in lesional and non-lesional skin biopsies, assessed by imaging mass cytometry (Hyperion). Reported as percentage of cells positive for each marker and/or cells per mm².
Time frame: From baseline (day 0) to end of treatment, week 16 (day 112)
Malignant T-Cell Clonality and Immune Cell Subset Composition by CITE-Seq
Change from baseline in malignant T-cell clonality and immune cell subset composition in lesional and non-lesional skin biopsies, assessed by CITE-seq (single-cell RNA sequencing combined with surface protein detection and T-cell receptor clonotyping). Reported as percentage of clonal T-cell frequency and relative frequency of immune cell subsets.
Time frame: From baseline (day 0) to end of treatment, week 16 (day 112)
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Jun 2028, 21 months later.
Of 33 non-industry phase 2 interventional studies under Mycosis Fungoides, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 119. This study's planned 21 months is below that.
Counting every sponsor, half of 42 studies reached it within 64 months; a quarter within 39 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Delgocitinib