AuthorisedTherapeutic confirmatory (Phase III)Interventional

LEISURE : Lenalidomide vs methotrexate in difficult-to-treat cutaneous lupus erythematosus (LEISURE trial): An assessor-blinded randomized clinical trial

The LEISURE study is a clinical trial investigating two treatments, methotrexate and lenalidomide, for people living with skin lupus that has been difficult to treat. The main goal is to find out if either medicine can reduce the activity of skin lupus by at least half after 16 weeks of treatment. Researchers will compare these two medicines to understand which is more effective at improving skin symptoms, such as rashes and lesions. They will also look at how these treatments affect a person's quality of life and general lupus activity, while also monitoring for any side effects. This study aims to find better ways to help people manage their skin lupus.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

122

Start

14 Nov 2025

Cutaneous lupus erythematosus

What is this study about?

The LEISURE trial focuses on a condition called cutaneous lupus erythematosus, which is a type of lupus that mainly affects the skin, causing rashes, sores, and other skin problems. Sometimes, these skin issues can be very stubborn and hard to treat, making everyday life challenging for those affected.

This study is designed to compare two different medicines: methotrexate and lenalidomide. Both are used to treat certain conditions, and researchers want to see which one might be more effective and safer for people with difficult-to-treat skin lupus. The main goal is to find out if either medicine can reduce the skin issues by at least 50% after a certain period. This is an important step towards finding better ways to help people manage their skin lupus symptoms.

Throughout the study, doctors will carefully track how participants' skin lupus changes, looking for improvements in rashes and sores. They will also check on participants' general health, quality of life, and any side effects from the medicines. The information gathered from this study will help doctors understand more about these treatments and could lead to improved care for people with skin lupus.

Key takeaways

This study compares two medicines for severe skin lupus.
It aims to find better treatments for difficult skin lupus symptoms.
Participation involves regular check-ups and monitoring of your skin and overall health.
The study assesses how treatments affect skin condition and quality of life.
All participants are adults (18+ years old) with active, hard-to-treat skin lupus.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with skin lupus. Both men and women are welcome to take part.

To be eligible, your skin lupus needs to be active and severe enough to be considered 'difficult to treat'. This means your doctors will use a special scoring system to confirm your skin lupus is causing significant problems that the study aims to address.

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.

Are you 18 years old or older?
Have you been diagnosed with cutaneous lupus erythematosus (skin lupus)?
Is your skin lupus currently active and considered difficult to treat by your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either methotrexate or lenalidomide, and your doctors won't know which one you're receiving (though you will receive one of these active drugs). You’ll have regular visits with the study team for medical check-ups, blood tests, and to assess your skin lupus. Specialists will use a specific scoring system to track changes in your skin condition. They will also ask you about your quality of life and any other symptoms you might have. The study will involve several visits over a number of weeks, with follow-up appointments to see how you are doing over time. The total duration of your participation, including treatment and follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in this study could potentially help improve your skin lupus symptoms, but there's no guarantee the treatment will work for you. Like all medicines, methotrexate and lenalidomide can have side effects, which the study team will monitor closely. You will be given full information about these potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'cutaneous lupus erythematosus'?

It's a form of lupus that mainly affects your skin, causing rashes and sores, especially on parts of your body exposed to the sun.

What is the study hoping to achieve?

The study aims to see if either methotrexate or lenalidomide can significantly reduce the skin problems caused by lupus in people whose condition has been hard to treat.

Will I know which medicine I'm getting?

No, this is an 'assessor-blinded' study, meaning the doctors assessing you won't know which treatment you are receiving, but you will know you are getting one of the active drugs being tested and not a placebo.

What does 'Phase III' mean?

Phase III means that if these medicines have already shown promise in earlier studies, this larger trial will confirm how effective they are and check for any side effects before they might become more widely available.

How long will I be in the study if I participate?

The study involves treatment over 16 to 24 weeks, with follow-up visits. The exact duration of your involvement will be thoroughly explained by the study team.