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Comparing lenalidomide and methotrexate for patients with difficult-to-treat cutaneous lupus erythematosus

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study involves cutaneous lupus erythematosus, which is a condition that causes skin problems such as rashes and lesions. It can occur on its own or together with a broader condition called systemic lupus erythematosus. The study will compare two different medications to see which one works better for people whose skin symptoms have not improved enough with their current treatments. One group of participants will take lenalidomide capsules by mouth once daily, while the other group will take methotrexate tablets by mouth once weekly. Both medications are being tested to see if they can reduce the active skin lesions caused by this condition.

The purpose of this study is to find out if lenalidomide is better than methotrexate at improving active skin lesions after sixteen weeks of treatment. During the study, participants will continue taking their medication for several months while doctors regularly check their skin condition using a scoring system that measures how active and severe the skin lesions are. The doctors will look at whether the skin lesions have decreased by at least half compared to the start of the study. Participants may also continue using their current medications such as antimalarials, low-dose steroids, or creams if their doses have been stable before joining the study.

Throughout the study, doctors will also measure other aspects of the condition, including how much the skin lesions improve at different time points, changes in quality of life, and whether the broader lupus condition becomes more or less active. The study will track any side effects that occur during treatment and follow-up periods. Women who can become pregnant will need to use effective birth control methods and have monthly pregnancy tests, as these medications can cause harm to an unborn baby. The study will continue for several years to gather enough information about how well these treatments work and how safe they are for people with difficult-to-treat skin lupus.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period begins

    At the start of the trial, you will be assigned to receive one of two treatment options.

    You will receive either lenalidomide at a dose of 5 mg per day taken by mouth, or methotrexate at a dose of 15 to 20 mg per week taken by mouth. The exact dose of methotrexate will depend on your body weight.

    Both medications are taken in capsule or tablet form.

    You will continue taking the assigned medication as directed throughout the treatment period.

  2. Step 2

    Week 16 assessment

    At week 16, your skin condition will be evaluated to measure changes in your lupus skin lesions.

    The assessment will use a scoring system called CLASI-A, which measures the activity level of skin lupus lesions.

    Your quality of life will also be assessed using a questionnaire called DLQI.

    If you have systemic lupus in addition to skin lupus, your overall lupus activity will be measured using scoring systems called SLEDAI and SFI.

    Any changes in the dose of corticosteroids you may be taking will be recorded.

    Any side effects or health problems will be documented.

  3. Step 3

    Week 24 assessment and end of treatment

    At week 24, your skin condition will be evaluated again using the same scoring systems.

    The CLASI-A score will be used to measure activity of your skin lesions, and CLASI-D will be used to measure any permanent skin damage.

    Your quality of life will be assessed again using the DLQI questionnaire.

    If you have systemic lupus, your overall lupus activity will be measured again.

    Changes in your corticosteroid dose since the beginning of the trial will be recorded.

    Any side effects or health problems that occurred during treatment will be documented.

    This marks the end of the active treatment period.

  4. Step 4

    Follow-up period

    After completing the treatment at week 24, you will enter a follow-up period.

    During this time, any ongoing or new side effects will continue to be monitored and recorded.

    The trial is expected to continue until May 2029.

Who can join the trial?

9 criteria

  • You must be at least 18 years of age or older
  • You must have a confirmed diagnosis of cutaneous lupus erythematosus, which is a condition that causes skin rashes and lesions, with or without systemic lupus erythematosus, which is a disease that can affect multiple organs in the body. This diagnosis must be confirmed by examining a small sample of your skin tissue under a microscope, either in the past or during the screening visit
  • Your skin disease must be currently active with a score of at least 8 on the CLASI-A scale, which is a measurement system doctors use to assess how severe and widespread your skin lesions are
  • Your skin condition must still be active despite being treated with antimalarial medications, which are drugs originally used for malaria but also help with lupus skin problems, for at least 3 months at a stable dose for at least 30 days before joining the study, or you previously had to stop these medications because they caused side effects or you could not tolerate them
  • If you are taking corticosteroids, which are medications that reduce inflammation, you must be on a stable dose of no more than 15 milligrams per day taken by mouth
  • If you are using topical corticosteroids, which are anti-inflammatory creams or ointments applied to the skin, or topical tacrolimus, which is another type of cream that suppresses the immune system on the skin, you must have been using a stable dose for at least 30 days before joining the study
  • If you are a woman who can become pregnant, you must agree to have monthly blood pregnancy tests and use highly effective contraception, which are methods to prevent pregnancy, for at least 4 weeks before starting the study treatment and until 4 weeks after the treatment ends
  • If you are a man, you must use contraceptive methods from the start of treatment until 1 month after the treatment ends
  • You must be able to understand and provide written informed consent, which means signing a document showing you understand the study and agree to participate

Who cannot join the trial?

4 criteria

  • The study document does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in participating, a doctor will need to review your complete medical history to determine if this study is appropriate for you
  • General exclusion reasons in clinical trials may include having certain other medical conditions, taking medications that could interfere with the study drug, being pregnant or planning to become pregnant, or having abnormal laboratory test results
  • Only a healthcare provider conducting this study can provide you with the complete list of reasons that would prevent participation
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Investigated drugs

  • Lenalidomide

    is a medicine that affects the immune system and helps reduce inflammation. In this trial, it is being tested to see if it can improve skin lesions caused by cutaneous lupus erythematosus, which is a condition that causes rashes and sores on the skin.

  • Methotrexate

    is a medicine that is commonly used to treat various inflammatory and autoimmune conditions. It works by slowing down the immune system's activity. In this trial, it is being compared to lenalidomide to see which medicine works better for treating difficult cases of skin lupus.

What is already known about the treatment

  • Lenalidomide

    Lenalidomide is a medication taken orally in capsule form, typically at a dose of 5 mg per day, and it belongs to a class of drugs called immunomodulatory agents that work by modifying the immune system's response. This medication is being studied in clinical trials for the treatment of cutaneous lupus erythematosus, a condition where the immune system attacks the skin causing rashes and lesions. At the molecular level, lenalidomide works by affecting certain immune cells and reducing inflammation, while also preventing the formation of new blood vessels that can contribute to disease activity. It has been approved for other conditions such as certain blood cancers, and researchers are now investigating whether it can help patients with difficult-to-treat skin lupus who have not responded well to standard treatments.

  • Methotrexate

    Methotrexate is an oral medication taken once weekly at doses of 15 to 20 mg, depending on the patient's weight, and it belongs to a class of drugs known as antimetabolites and immunosuppressants. This medication is widely used in medicine for various autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriasis, and lupus, and is considered a standard treatment option for cutaneous lupus erythematosus. At the molecular level, methotrexate works by blocking an enzyme needed for cells to multiply and by reducing the activity of the immune system, which helps decrease inflammation and prevent the immune system from attacking healthy skin tissue. It is an established treatment that has been used for decades and serves as a comparison treatment in this clinical trial to evaluate whether lenalidomide might offer better results for patients with skin lupus.

Investigated diseases

  • Cutaneous Lupus Erythematosus

    Cutaneous lupus erythematosus is a skin condition that causes inflammation and lesions on areas of the skin. The disease can occur on its own or as part of systemic lupus erythematosus, which affects multiple body systems. Common symptoms include red, scaly patches or raised bumps on the skin, particularly in areas exposed to sunlight. The lesions may appear on the face, scalp, ears, and other parts of the body. The condition tends to flare up and improve over time, with periods of increased activity followed by calmer phases. Over time, active skin lesions may lead to permanent scarring and changes in skin color or texture.

  • Systemic Lupus Erythematosus

    Systemic lupus erythematosus is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues throughout the body. The disease can affect multiple organs and systems including the skin, joints, kidneys, heart, lungs, and blood vessels. Symptoms vary widely from person to person and may include fatigue, joint pain, skin rashes, and fever. The condition typically follows a pattern of flare-ups, when symptoms worsen, alternating with periods of remission when symptoms improve or disappear. The severity and progression of the disease differ greatly among individuals. Over time, inflammation caused by the disease can lead to permanent damage in affected organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520089-70-00Protocol codeAPHP240920Estimated enrolment122 patientsSponsorAssistance Publique Hopitaux De Paris

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