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Mycosis FungoidesPhase 2NCT07781449

Topical JAK-Inhibition of Early-Stage CTCL

A Phase 2 study testing delgocitinib in people with Mycosis Fungoides and Cutaneous T-cell Lymphoma, run by Aarhus University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mycosis Fungoides, Cutaneous T-cell Lymphoma
What is being tested?
delgocitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Sep 2026to Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
delgocitinib
Keywords
JAK inhibitor, Delgocitinib, Anzupgo, Early-stage mycosis fungoides, Cutaneous T-cell Lymphoma, Pan-JAK inhibitor
Medical subject headings
Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • delgocitinibDrug

    Also called Anzupgo

    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.

Study groups in NCT07781449
Study groupRoleWhat they receive
DelgocitinibExperimentalParticipants apply delgocitinib 20 mg/g cream (Anzupgo) topically to affected skin areas twice daily for 16 weeks.
Receives: Drug: delgocitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  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)

    Measured: 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).

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07781449
Sponsor's protocol ID
2025-523472-23-01
Other IDs
2025
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.

    PubMed 17540844

  • Soerensen SBT, Nagy D, Odum N, Iversen L, Lindahl LM. Chronic Obstructive Pulmonary Disease and Risk of Cutaneous T-cell Lymphoma: A Danish Population-based Cohort Study. Acta Derm Venereol. 2023 Aug 22;103:adv5238. doi: 10.2340/actadv.v103.5238. No abstract available.

    PubMed 37606154

  • Fredholm S, Willerslev-Olsen A, Met O, Kubat L, Gluud M, Mathiasen SL, Friese C, Blumel E, Petersen DL, Hu T, Nastasi C, Lindahl LM, Buus TB, Krejsgaard T, Wasik MA, Kopp KL, Koralov SB, Persson JL, Bonefeld CM, Geisler C, Woetmann A, Iversen L, Becker JC, Odum N. SATB1 in Malignant T Cells. J Invest Dermatol. 2018 Aug;138(8):1805-1815. doi: 10.1016/j.jid.2018.03.1526. Epub 2018 May 8.

    PubMed 29751003

  • Munir S, Andersen GH, Woetmann A, Odum N, Becker JC, Andersen MH. Cutaneous T cell lymphoma cells are targets for immune checkpoint ligand PD-L1-specific, cytotoxic T cells. Leukemia. 2013 Nov;27(11):2251-3. doi: 10.1038/leu.2013.118. Epub 2013 Apr 18. No abstract available.

    PubMed 23660624

  • Krejsgaard T, Vetter-Kauczok CS, Woetmann A, Kneitz H, Eriksen KW, Lovato P, Zhang Q, Wasik MA, Geisler C, Ralfkiaer E, Becker JC, Odum N. Ectopic expression of B-lymphoid kinase in cutaneous T-cell lymphoma. Blood. 2009 Jun 4;113(23):5896-904. doi: 10.1182/blood-2008-09-181024. Epub 2009 Apr 7.

    PubMed 19351960

  • Buus TB, Willerslev-Olsen A, Fredholm S, Blumel E, Nastasi C, Gluud M, Hu T, Lindahl LM, Iversen L, Fogh H, Gniadecki R, Litvinov IV, Persson JL, Bonefeld CM, Geisler C, Christensen JP, Krejsgaard T, Litman T, Woetmann A, Odum N. Single-cell heterogeneity in Sezary syndrome. Blood Adv. 2018 Aug 28;2(16):2115-2126. doi: 10.1182/bloodadvances.2018022608.

    PubMed 30139925

  • Peiffer L, Gambichler T, Buus TB, Horny K, Gravemeyer J, Furtmann F, Spassova I, Kubat L, Susok L, Stranzenbach R, Srinivas N, Odum N, Becker JC. Phenotypic plasticity of malignant T cells in blood and skin of a Sezary syndrome patient revealed by single cell transcriptomics. Front Oncol. 2023 Jan 25;13:1090592. doi: 10.3389/fonc.2023.1090592. eCollection 2023.

    PubMed 36761972

  • Buus TB, Herrera A, Ivanova E, Mimitou E, Cheng A, Herati RS, Papagiannakopoulos T, Smibert P, Odum N, Koralov SB. Improving oligo-conjugated antibody signal in multimodal single-cell analysis. Elife. 2021 Apr 16;10:e61973. doi: 10.7554/eLife.61973.

    PubMed 33861199

  • Herrera A, Cheng A, Mimitou EP, Seffens A, George D, Bar-Natan M, Heguy A, Ruggles KV, Scher JU, Hymes K, Latkowski JA, Odum N, Kadin ME, Ouyang Z, Geskin LJ, Smibert P, Buus TB, Koralov SB. Multimodal single-cell analysis of cutaneous T-cell lymphoma reveals distinct subclonal tissue-dependent signatures. Blood. 2021 Oct 21;138(16):1456-1464. doi: 10.1182/blood.2020009346.

    PubMed 34232982

  • Solimani F, Meier K, Ghoreschi K. Emerging Topical and Systemic JAK Inhibitors in Dermatology. Front Immunol. 2019 Dec 3;10:2847. doi: 10.3389/fimmu.2019.02847. eCollection 2019.

    PubMed 31849996

  • Lindahl LM, Willerslev-Olsen A, Gjerdrum LMR, Nielsen PR, Blumel E, Rittig AH, Celis P, Herpers B, Becker JC, Stausbol-Gron B, Wasik MA, Gluud M, Fredholm S, Buus TB, Johansen C, Nastasi C, Peiffer L, Kubat L, Bzorek M, Eriksen JO, Krejsgaard T, Bonefeld CM, Geisler C, Mustelin T, Langhoff E, Givskov M, Woetmann A, Kilian M, Litman T, Iversen L, Odum N. Antibiotics inhibit tumor and disease activity in cutaneous T-cell lymphoma. Blood. 2019 Sep 26;134(13):1072-1083. doi: 10.1182/blood.2018888107. Epub 2019 Jul 22.

    PubMed 31331920

  • Blaizot R, Ouattara E, Fauconneau A, Beylot-Barry M, Pham-Ledard A. Infectious events and associated risk factors in mycosis fungoides/Sezary syndrome: a retrospective cohort study. Br J Dermatol. 2018 Dec;179(6):1322-1328. doi: 10.1111/bjd.17073. Epub 2018 Oct 12.

    PubMed 30098016

  • Willerslev-Olsen A, Krejsgaard T, Lindahl LM, Bonefeld CM, Wasik MA, Koralov SB, Geisler C, Kilian M, Iversen L, Woetmann A, Odum N. Bacterial toxins fuel disease progression in cutaneous T-cell lymphoma. Toxins (Basel). 2013 Aug 14;5(8):1402-21. doi: 10.3390/toxins5081402.

    PubMed 23949004

  • Castillo DE, Romanelli P, Lev-Tov H, Kerdel F. A case of erythrodermic mycosis fungoides responding to upadacitinib. JAAD Case Rep. 2022 Oct 15;30:91-93. doi: 10.1016/j.jdcr.2022.10.010. eCollection 2022 Dec. No abstract available.

    PubMed 36411841

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing delgocitinib in people with Mycosis Fungoides and Cutaneous T-cell Lymphoma, run by Aarhus University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elisabeth Linde Grove, MD (+45 42484614, au553240@uni.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Safety and Tolerability of Topical Delgocitinib] (time frame: From baseline (day 0) to end of treatment week 16 (day 112)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07781449, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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