A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants with Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations.
Cutaneous lupus erythematosus is an autoimmune condition that causes skin inflammation, painful sores, and scaly rashes. Current treatments do not work for everyone, so researchers are searching for better options. This Phase 2b study is testing an investigational drug called IMVT-1402. The main goal is to find out if the treatment is safe, well tolerated, and capable of calming active skin flare-ups. Adults aged 18 and older with active subacute or chronic skin lupus can join. Participants will be randomly chosen to receive either IMVT-1402 or an identical dummy treatment (a placebo). Neither you nor your study doctor will know which one you receive. Doctors will measure changes in your skin over 12 weeks using a standard scoring system to see if the medicine clearly clears up rashes and sores.
At a glance
What is this study about?
Cutaneous lupus erythematosus is a long-term condition where the body's immune system mistakenly attacks healthy skin. This can lead to painful, itchy rashes, scaly patches, and sometimes permanent scarring. There are different forms, including subacute cutaneous lupus (which often causes ring-shaped rashes on sun-exposed areas) and chronic cutaneous lupus (which can cause thick, disc-shaped sores). For many people, existing medicines like steroid creams or standard pills do not give enough relief or cause difficult side effects.
This clinical trial is testing a new medicine called IMVT-1402. The drug is designed to lower specific proteins in the immune system that drive inflammation in the skin. Because this is a Phase 2b trial, researchers already have some early safety data, but they now need to test how well the medicine works across a larger group of people and find out what dose is most effective.
To make sure the results are fair and reliable, this is a 'double-blind, placebo-controlled' study. This means some participants will receive IMVT-1402, while others will receive a placebo, which looks identical but contains no active medicine. A computer decides who gets which treatment by chance, and neither you nor the trial team will know your group until the study ends.
Doctors will track your progress closely, focusing on whether your skin symptoms improve over the first 12 weeks. They will use a recognised medical tool called the CLASI-A score, which measures the redness, swelling, and surface area of lupus rashes. If IMVT-1402 successfully reduces these scores, it could lead to an important new treatment option for people living with skin lupus.
Key takeaways
- Tests a new medicine, IMVT-1402, for adults with active subacute or chronic skin lupus.
- A Phase 2b trial comparing the active drug against an inactive dummy treatment (placebo).
- The main goal is to measure how much skin rashes and sores improve over 12 weeks.
- Open to adults aged 18 and over, whether lupus affects only the skin or the whole body.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with active skin lupus. This includes two main types: subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE), such as discoid lupus. Both men and women can join.
You may be able to take part whether your lupus only affects your skin or also causes symptoms elsewhere in your body (systemic lupus), as long as your skin is currently active and inflamed. The study team will need to confirm that you have visible rashes or sores that can be measured at the start of the study.
You might not be eligible if you have certain other severe medical conditions, active serious infections, or if you are taking specific medications that could interfere with the study drug. The trial doctors will review your complete medical history and carry out health checks before you can be accepted onto the study.
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 subacute or chronic cutaneous lupus (such as discoid lupus).
- I currently have active, visible skin rashes or sores.
- I am able and willing to attend regular clinic appointments over several months.
- I am open to receiving either the study drug or a dummy treatment (placebo).
What does participation involve?
If you decide to join, you will first attend a screening visit where doctors check your health, examine your skin, and take blood and urine samples. If you qualify, you will enter the 12-week main study period. During this time, you will receive either IMVT-1402 or the placebo. You will have regular appointments at the study clinic so doctors can monitor your vital signs, check for any side effects, and score your skin's healing progress. Total participation involves several clinic visits over a few months, and you will have follow-up checks after treatment ends to ensure you stay well.
Potential risks and benefits
Locations (5)
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedBulgaria
Common questions
What is a placebo and why is it used?
A placebo is a dummy treatment that looks just like the real medicine but has no active ingredients. Researchers use it to see whether changes in health are truly caused by the new drug rather than everyday changes or psychological factors.
What is the CLASI-A score mentioned in the study?
CLASI-A stands for Cutaneous Lupus Erythematosus Disease Area and Severity Index (Activity). It is a simple scoring checklist doctors use to grade how red, swollen, and widespread your skin rashes are.
Can I carry on seeing my usual GP or specialist?
Yes. The trial team will work alongside your normal healthcare providers, and you should keep attending your routine appointments unless your doctor advises otherwise.
Will taking part cost me anything?
No. The study medication and all trial tests are provided free of charge. Most clinical trials also cover reasonable travel costs and parking expenses for clinic visits.
What happens if I change my mind during the trial?
You can leave the study at any time, for any reason. You do not need to give an explanation, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.