A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)
This study is testing a new medicine called lebrikizumab for people who have a skin condition called localised scleroderma. This condition causes patches of skin to become hard and tight. Researchers want to find out if this new medicine, given as an injection, can help improve these skin changes and if it's safe to use. Half the people taking part will receive lebrikizumab, while the other half will receive a 'dummy' injection (placebo) that looks the same but contains no medicine. Neither the patients nor their doctors will know who is getting which treatment. The main goal is to see how much the skin patches change after 24 weeks of treatment.
At a glance
What is this study about?
This research study is looking into a new treatment for a skin condition called localised scleroderma. If you have this condition, your skin can become thick and hard in certain areas. This study is testing a new medicine called lebrikizumab to see if it can help soften the skin and reduce other symptoms.
Researchers want to see if lebrikizumab is effective and safe to use. To do this, they will compare it to a 'dummy' treatment, also known as a placebo. This means some people in the study will get the new medicine, and others will get an injection that looks exactly like the study medicine but doesn't contain any active drug. Neither you nor your study doctor will know which one you are receiving – this is a common way to make sure the results are fair and unbiased.
The main thing researchers will be looking at is how your skin patches change over 24 weeks. They will use a special scoring system to measure these changes. By comparing those who received lebrikizumab with those who received the placebo, they can understand how well the new medicine works. This is a Phase II study, which means it’s still in the earlier stages of testing new medicines to understand their effects and appropriate doses.
Key takeaways
- This study tests a new medicine (lebrikizumab) for localised scleroderma.
- It aims to see if the medicine improves skin and is safe.
- Half of participants get the new medicine, half get a dummy (placebo).
- Neither you nor your doctor will know which treatment you receive.
- The main goal is to measure skin changes over 24 weeks.
- You must be 18 or older to join.
Who may be eligible?
To be able to join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.
Beyond basic age and sex requirements, the detailed rules for who can join are quite specific to make sure the study includes people who will benefit most and can safely take part. For example, you would need to have localised scleroderma to be considered.
Your study doctor will discuss all the specific details with you to confirm if this study is suitable for your individual health situation. They will make sure it's the right fit for you to take part.
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 localised scleroderma?
- Are you able to attend regular clinic appointments?
- Are you willing to take an injected medicine?
- Are you prepared not to know if you are receiving the active medicine or a placebo?
What does participation involve?
If you decide to join this study, you will have regular visits to the clinic over several months. You will receive either the study medicine (lebrikizumab) or a placebo as an injection in a pre-filled syringe. You'll be shown how to use this safely. Throughout the study, doctors and nurses will carry out various checks and assessments, including carefully measuring changes in your skin patches regularly. These assessments will help the researchers understand how the treatment is working and if it's safe for you. The study will last for a specific period, but the length isn't fully detailed here, so your study team will tell you the exact duration and how many follow-up appointments there will be after you stop taking the medicine.
Potential risks and benefits
Locations (1)
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Common questions
What is localised scleroderma?
It's a skin condition where patches of skin become hard, thick, and sometimes discoloured. It's different from the more widespread form of scleroderma that can affect internal organs.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks exactly like the real study medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know which treatment you are receiving during the study. This is called 'double-blind' and helps ensure the study results are fair.
How will the doctors know if the medicine is working?
They will regularly measure changes in your skin patches using a special scale, and compare these changes between those who received the active medicine and those who received the placebo.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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