A Phase 2, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of LAD603 in patients with systemic lupus erythematosus
Systemic lupus erythematosus, usually called lupus, is a long-term condition where the immune system mistakenly attacks healthy tissue. This can cause joint pain, tiredness, and skin rashes. This Phase 2 clinical trial is looking at a new experimental medicine called LAD603 to see if it can help reduce these symptoms. Researchers are comparing LAD603 against a placebo, which looks identical but contains no active medicine. Neither you nor the study team will know which one you receive. The main goal is to measure how much the treatment improves lupus skin symptoms using a standard medical scoring system. The study will also carefully check for any side effects to make sure the medicine is safe. Taking part is completely voluntary and will not affect your standard NHS care.
At a glance
What is this study about?
Lupus is an autoimmune condition where the body's natural defence system gets confused and attacks healthy parts of the body instead of fighting off bugs. It can affect many organs, but it very commonly causes painful joints, extreme fatigue, and red or inflamed skin rashes that can flare up unpredictably. While there are treatments available today, they do not work well for everyone, and better options are urgently needed.
This trial is exploring a new treatment called LAD603. It is designed to help calm the overactive immune response that drives lupus. Because this is a Phase 2 trial, scientists already have some early safety data, but they now need to test it in a larger group of people with lupus to see how well it works and monitor side effects closely.
A key focus of the study is measuring improvements in skin rashes and sores using a tool called the CLASI-A score. Doctors use this score to rate how active and severe lupus skin symptoms are before and after treatment. If LAD603 shows good results, it could move on to larger trials and potentially become a new treatment option in the future.
Key takeaways
- Testing a new medicine, LAD603, for adults with systemic lupus erythematosus.
- Compares the study drug to a dummy pill (placebo) to test its safety and effectiveness.
- A main focus is seeing if it reduces lupus-related skin rashes and inflammation.
- Participants will receive regular, detailed health checks from specialist doctors.
- Participation is entirely voluntary, and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with systemic lupus erythematosus. Because the trial specifically tracks changes in skin rashes, participants will usually need to have active lupus symptoms that affect their skin.
You may not be able to take part if you have other severe medical conditions, active severe infections, or if you are currently taking certain other experimental drugs. Pregnant or breastfeeding women are typically excluded to protect the baby.
The research team at the hospital will review your medical history and run standard health checks to confirm whether this study is safe and suitable for you.
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 medical diagnosis of systemic lupus erythematosus (lupus).
- I have active lupus symptoms, such as skin rashes.
- I am able and willing to attend regular hospital check-ups.
- I am not currently pregnant or planning to become pregnant during the study.
What does participation involve?
If you decide to join, you will first attend a screening visit to check your general health, blood, and lupus symptoms. If you qualify, you will be randomly placed into one of two groups: one group receives the study drug LAD603, and the other receives a matching placebo (a dummy treatment). Neither you nor your study doctor can choose your group, ensuring the results are fair.
During the trial, you will need to attend regular clinic visits. At these visits, doctors will check your skin rashes, test your blood and urine, ask about your symptoms, and check for any side effects. You will receive clear instructions on how the study medicine is taken. The study lasts for several months, followed by a safety check-up after treatment finishes.
Potential risks and benefits
Locations (4)
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedBulgaria
Common questions
What is a placebo?
A placebo looks just like the real study drug but contains no active medicine. It helps researchers prove whether any improvements are truly caused by LAD603.
Can I carry on taking my usual lupus medication?
Often you can stay on certain stable background medicines, but some treatments may need to be paused. The study doctor will review your current prescriptions.
Will taking part cost me anything?
No, the study medicine and all tests are provided free of charge. Most trials also help cover reasonable travel expenses to and from the clinic.
What happens if I change my mind?
Joining is completely voluntary. You are free to withdraw from the trial at any point, and it will never affect the quality of your normal medical care.
Why is this called a Phase 2 trial?
Phase 2 trials test a new treatment in a moderate number of patients to see if it is effective for a specific condition and to find the safest dose.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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