A Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the efficacy and safety of daxdilimab subcutaneous injection in reducing disease activity in adult participants with moderate-to-severe primary discoid lupus erythematosus.
This research study is testing a new medication called daxdilimab for adults living with moderate to severe primary discoid lupus erythematosus. This condition mainly affects the skin, causing rashes and scarring. The study aims to find out if daxdilimab, given as an injection under the skin, can effectively reduce the symptoms of the disease and make people feel better. Researchers will also be checking if the treatment is safe to use. Some participants will receive the actual medication, while others will receive a 'dummy' treatment (placebo) to fairly compare the results. The study will look closely at changes in skin affected by lupus over about 24 weeks.
At a glance
What is this study about?
This study is about a condition called discoid lupus erythematosus, which is a type of lupus that mainly causes problems with your skin. It can lead to red, scaly patches, often on the face, scalp, and ears, which can sometimes result in scarring and hair loss. If you have this condition, you'll know how much it can affect your daily life and confidence.
Doctors are exploring a new medicine called daxdilimab. They want to see if this new treatment, given as an injection under the skin, can help reduce the severity of these skin problems. The main way they'll measure this is by looking at how much your skin symptoms improve over a period of 24 weeks, comparing those who get daxdilimab with those who get a dummy treatment.
This is a 'Phase 2' study, which means it's an important step in testing new medicines. It's designed to get a clearer idea of how well the drug works and any side effects it might have. This information will help decide if daxdilimab should be tested in even larger studies in the future, hopefully leading to a new treatment option for people with discoid lupus.
Key takeaways
- This study is testing a new medicine for skin lupus.
- It aims to see if the medicine improves skin symptoms and is safe.
- Participation involves injections and regular check-ups over 6 months.
- Some participants will receive a dummy treatment (placebo).
- You have the right to withdraw from the study at any point.
- This is a Phase 2 trial, an important step in drug development.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women. You must also have primary discoid lupus erythematosus that is considered moderate to severe – this means your skin symptoms are affecting you quite a bit.
The research team will need to check your medical history and do some tests to make sure that the study is safe for you and that your specific type of discoid lupus matches what they are looking for. They might need to check if you're taking certain other medications or if you have any other health conditions that could affect the study results or your safety.
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?
- Do you have discoid lupus erythematosus?
- Are your skin symptoms considered moderate to severe?
- Are you prepared to attend regular clinic visits for about 6 months?
What does participation involve?
If you join this study, it would involve several visits to a clinic over about 24 weeks, which is roughly six months. During these visits, the research team would give you the study medication, which is an injection under your skin. You will either receive the active medication, daxdilimab, or a placebo (a dummy injection that looks the same but contains no medicine).
At your visits, the doctors and nurses will carefully check your skin, take measurements of your symptoms, and ask you about how you are feeling. They will also take blood samples to see how the medicine is working in your body and to check for any side effects. You will have regular follow-up appointments to monitor your progress and safety throughout the study duration.
Potential risks and benefits
Locations (7)
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedGreece
- —UnverifiedBulgaria
Common questions
What is discoid lupus erythematosus?
It's a long-term skin condition and a type of lupus that causes red, scaly patches, often on the face and scalp, which can lead to scarring.
What does 'placebo-controlled' mean?
It means some people will get the new medicine, and others will get a 'dummy' injection without any active drug. This helps doctors see if the new medicine really works better than no treatment.
How will they know if the medicine is working?
Doctors will regularly check your skin symptoms using special scoring systems and ask you about how you feel over 24 weeks.
What is 'daxdilimab'?
Daxdilimab is the name of the new medication being tested in this study. It's designed to potentially help with discoid lupus symptoms.
Can I stop being in the study if I change my mind?
Yes, you are free to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.