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Topical delgocitinib safety study in patients with cutaneous T‑cell lymphoma (mycosis fungoides)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on a rare skin cancer called Cutaneous T-cell lymphoma, which often appears as a form known as Mycosis fungoides. Participants will use a cream that contains the active ingredient delgocitinib, a type of JAK inhibitor that works by blocking signals that can cause inflammation and abnormal cell growth. The purpose of the study is to evaluate the safety and tolerability of this topical treatment.

People who join the study will apply the cream to affected skin areas twice each day for about four months. During this time they will attend regular clinic visits where doctors will look at the skin and record changes using a scoring system called mSWAT, which rates how much of the skin is involved and how severe the patches are. Participants will also answer simple questionnaires about itching (called pruritus) and how the skin condition affects daily life. Small skin samples may be taken to explore how the medicine works, and a gentle test may be performed to see if the skin barrier improves. The study ends after the treatment period, and the collected information helps researchers understand whether the cream is safe and how well it works for this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    After joining the study you will have an initial visit where you sign the consent form and confirm that you have cutaneous t‑cell lymphoma (ctcl).

    The study team will record your medical history, take photographs of the skin lesions, and ask you to complete questionnaires about itching and quality of life.

  2. Step 2

    Baseline assessments

    A skin assessment using the modified severity‑weighted assessment tool (mswat) will be performed to establish a baseline score.

    Skin biopsies may be taken from both affected and unaffected areas to allow later laboratory analysis.

  3. Step 3

    Start of medication

    You will receive anzupgo 20 mg/g cream, which contains the active substance delgocitinib.

    Each application should contain the amount that provides 2 mg of delgocitinib per gram of cream, as instructed by the study team.

    The cream is for topical use only; do not ingest or apply to mucous membranes.

  4. Step 4

    Home treatment period (weeks 1‑16)

    You will apply the cream to the designated skin areas for a total duration of 16 weeks.

    The exact frequency of application (for example, once or twice daily) will be explained by the study staff and must be followed exactly.

    Keep a daily log of each application and any skin changes or side effects you notice.

  5. Step 5

    Scheduled follow‑up visits

    You will return to the clinic at regular intervals, typically every four weeks (week 4, week 8, week 12, and week 16).

    During each visit the study team will repeat the mswat skin assessment, review your itching score, and check for any adverse reactions.

    Additional questionnaires about skin‑related quality of life may be completed at these visits.

  6. Step 6

    Final assessment (week 16)

    At the end of week 16 the study will perform the final skin assessment to determine the change in the mswat score from baseline.

    The overall skin response (complete response, partial response, stable disease, or progressive disease) will be categorized based on predefined criteria.

    Final questionnaires and any required biopsies will be collected.

  7. Step 7

    Study completion

    After the final assessment you will be informed that your participation in the study is complete.

    The study team will discuss the results of the safety and tolerability evaluation and any next steps for your care.

Who can join the trial?

5 criteria

  • Be a man or a woman who is at least 18 years old when you agree to join the study.
  • Have a diagnosis of mycosis fungoides that has been histologically confirmed (meaning a doctor looked at a tissue sample under a microscope to be sure) and be in an early stage called IA, IB, or IIA.
  • Your disease should be stable (not getting worse quickly) and you should need palliative treatment (therapy that helps relieve symptoms rather than cure the disease).
  • You must not have changed any of your medicines for at least 2 months before starting the study.
  • You need to be willing to take part, understand what the study involves, and be able to give informed consent (agreeing after being fully explained), with this consent obtained before any study procedures begin.

Who cannot join the trial?

8 criteria

  • You are allergic (hypersensitive) to the study drug or any of its inactive ingredients (excipients) such as benzyl alcohol, butylhydroxyanisole, or cetostearyl alcohol.
  • You have Sézary syndrome, a type of blood cancer where abnormal T‑cells (a kind of white blood cell) are found in the bloodstream.
  • You are using other skin‑directed treatments at the same time (concomitant treatment), such as light therapy (phototherapy), radiation therapy (radiotherapy), chlormethine gel, or steroid creams (topical corticosteroids).
  • You have a mental health condition, disability, or social situation that could make it unsafe for you to join the study or prevent you from giving proper consent (psychiatric illness, disability).
  • You have a past history of non‑melanoma skin cancer (NMSC), which is a skin cancer that is not melanoma.
  • You have eczema (atopic dermatitis) or another skin disease that is important for your health.
  • You have other serious medical problems, such as an ongoing skin infection that needs antibiotics or abnormal lab results or vital signs that the doctor (investigator) thinks could put you at risk or affect the study results (vital sign abnormalities).
  • You are pregnant or are breastfeeding.
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Investigated drugs

Anzupgo is a skin‑applied cream that contains a medication known as a JAK inhibitor. In this study, the cream is being tested as a new way to treat cutaneous T‑cell lymphoma, a type of skin cancer that involves immune cells. By blocking specific signals inside the skin cells, the cream aims to reduce the abnormal growth of these cells and improve skin symptoms. Participants in the trial will apply the cream to the affected areas, and researchers will watch closely for any side effects and how well the skin responds to the treatment.

What is already known about the treatment

Anzupgo 20 mg/g cream - Anzupgo 20 mg/g cream is applied topically to the skin as a thin layer and gently rubbed in. It contains delgocitinib, a JAK inhibitor that is approved in some countries for inflammatory skin conditions and is being studied in medical literature for its safety and effectiveness. The cream is used to treat cutaneous T‑cell lymphoma, especially mycosis fungoides, a rare skin cancer. Delgocitinib works by blocking the Janus kinase enzymes inside cells, which reduces signaling that leads to inflammation and abnormal cell growth, placing it in the class of topical Janus kinase inhibitors.

Investigated diseases

Mycosis fungoides - Mycosis fungoides is a type of skin lymphoma that originates from T‑cells in the outer layer of the skin. It usually begins as flat, red patches that may be itchy or scaly. Over time the patches can become thicker plaques and later develop into raised tumors. The disease can spread from the skin to nearby lymph nodes and, in later stages, to internal organs. Skin changes may become more widespread as the condition advances.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523472-23-01Estimated enrolment15 patientsSponsorRegion Midtjylland

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).