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
Cutaneous T-cell lymphoma (CTCL), which includes a common type called mycosis fungoides, is a rare condition where certain white blood cells collect in the skin. It often leads to dry, red, itchy patches that can be difficult to treat and distressing to manage. This early-stage clinical trial is testing a prescription cream named Anzupgo (a type of medicine known as a JAK inhibitor). JAK inhibitors work by blocking specific signals inside cells that trigger inflammation. Over 16 weeks, researchers want to see how well the cream clears skin patches and whether it eases severe itching. Because this is an 'open-label' study, all participants will receive the active cream rather than a dummy treatment (placebo). The study will also collect small skin samples to see how the cream repairs the skin's protective barrier.
At a glance
What is this study about?
Cutaneous T-cell lymphoma (CTCL) is a rare, long-term condition where certain white blood cells (T-cells) become abnormal and travel to the skin. The most common form is called mycosis fungoides. It often starts as dry, red, scaly patches that look similar to eczema or psoriasis. Alongside visible rashes, many people experience intense, persistent itching that can disrupt sleep and make everyday life challenging.
Treating CTCL often involves creams, light therapy, or medicines that work throughout the whole body. This clinical trial is exploring a targeted approach using Anzupgo cream. Anzupgo belongs to a family of drugs called JAK inhibitors. These medicines work by blocking chemical pathways that tell the immune system to create inflammation. By applying the treatment directly to the skin, doctors hope to calm the overactive cells right where they cause trouble, with fewer side effects than oral tablets.
During the study, researchers will closely track changes in participants' skin patches over 16 weeks. They will also look at how much the cream reduces itching and whether it improves daily well-being. Additionally, doctors will study small skin samples under a microscope to understand how the cream restores the skin's natural barrier. If successful, this trial could help pave the way for a gentle, effective new option for people living with CTCL.
Key takeaways
- The trial tests Anzupgo cream, a targeted anti-inflammatory medicine, for cutaneous T-cell lymphoma.
- Treatment lasts for 16 weeks with regular check-ups to track your skin and symptoms.
- Everyone in this study receives the active cream; there is no dummy treatment.
- The study measures how well the cream clears patches, calms itch, and improves quality of life.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with cutaneous T-cell lymphoma (CTCL), including the mycosis fungoides subtype. Both men and women can take part.
To be suitable, participants need to have active skin patches that can be measured and monitored by the study team. You must also be able and willing to apply the cream as directed and attend regular check-ups at the study clinic.
Certain people may not be able to join. For example, if you are currently using other specific skin treatments, have active skin infections, or have other serious medical conditions, this trial might not be safe for you. The study doctor will review your full medical history to confirm whether it is safe to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a confirmed diagnosis of cutaneous T-cell lymphoma or mycosis fungoides.
- I currently have visible, active skin patches or lesions.
- I am able to attend regular hospital or clinic appointments over 16 weeks.
- I am willing to apply a medicated cream and have small skin samples (biopsies) taken.
What does participation involve?
If you take part, your involvement will last for around 16 weeks. You will be given Anzupgo cream to apply directly to the affected areas of your skin at home, following instructions from the medical team.
You will need to attend regular clinic appointments so the team can monitor your health. During these visits, doctors will examine your skin using a standard scoring system to see if the patches are shrinking or fading. You will be asked to rate your itching and complete short questionnaires about your quality of life. The team will also check your skin's moisture barrier and take small skin samples (biopsies) under local anaesthetic to study the medicine's effects in the laboratory.
Potential risks and benefits
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Common questions
What is cutaneous T-cell lymphoma?
It is a rare condition where T-cells (a type of white blood cell that normally fights infection) build up in the skin, causing red patches, plaques, and itching.
Will I receive a dummy treatment (placebo)?
No. This is an open-label pilot study, meaning every person who joins will receive the active Anzupgo cream.
Do I have to pay for the study treatment?
No, clinical trial medicines and study-related tests are provided free of charge.
Will having a skin biopsy hurt?
Skin biopsies are done using a local anaesthetic injection to numb the area completely, so you should only feel a small pinch from the needle.
What happens if my skin gets worse during the trial?
Your safety comes first. The medical team will check your skin regularly, and if the condition worsens or you experience severe side effects, they will stop the cream and discuss alternative treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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