A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
This research study is looking into a new oral medication called brepocitinib for adults living with a form of hair loss known as lichen planopilaris (LPP). LPP causes inflammation that damages hair follicles, leading to permanent hair loss. The main goal of this study is to find out if brepocitinib is a safe and effective treatment. Participants will either receive the active medication or a placebo, which is a dummy pill with no active ingredients. This helps researchers understand the true effects of the new medicine. The study will carefully check how well the medicine works to reduce symptoms and if there are any side effects. It's a key step in potentially finding new ways to help people with LPP.
At a glance
What is this study about?
Lichen planopilaris (LPP) is a skin condition that affects the scalp, leading to sore, itchy patches and eventually permanent hair loss. It happens when the body's immune system mistakenly attacks healthy hair follicles. There isn't a simple cure for LPP, and current treatments aim to manage symptoms and slow down hair loss. This is why researchers are constantly looking for new and better ways to help people living with this condition.
This study, called a Phase 2/3 trial, is investigating a new medicine called brepocitinib. The goal is to see if brepocitinib can safely and effectively reduce the inflammation and symptoms associated with LPP. In this type of study, some participants will receive the active medication, while others will receive a placebo (a tablet that looks the same but contains no medicine). This is a common and important way to test new medicines, as it helps scientists accurately understand the medicine's true effects compared to receiving no specific treatment.
By taking part, you would be contributing to scientific understanding about LPP and helping to explore potential new treatments. The information gathered from this study will be used to determine if brepocitinib could menjadi a safe and useful option for people with LPP in the future. All information collected from participants is kept confidential.
Key takeaways
- This study is testing a new oral medicine (brepocitinib) for lichen planopilaris (LPP).
- It aims to find out if the medicine is safe and effective for adults with LPP.
- Participants will receive either the study drug or a placebo (dummy pill).
- You will have regular check-ups and medical tests if you participate.
- Taking part helps advance understanding and potential new treatments for LPP.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. You must have been diagnosed with lichen planopilaris (LPP) based on a scalp biopsy, and your LPP needs to be active and causing symptoms when you join the study. Also, your weight should be between 40 kg and 130 kg (about 6 stone 4 pounds to 20 stone 6 pounds), and your Body Mass Index (BMI) should be 45 or less.
There are also some reasons why you might not be able to join. For example, if you've had certain types of blood or immune system disorders, or most types of cancer within the last five years, you wouldn't be eligible. Some minor skin cancers or certain early-stage cancers might be exceptions.
The study also can't include people who have a high risk of blood clots, heart disease, or shingles (a viral infection). If you currently have an infection or have had a recent infection, you might not be able to participate. These rules are in place to help keep participants safe and ensure the study results are clear.
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 lichen planopilaris (LPP) by a doctor, confirmed by a scalp biopsy?
- Is your LPP currently active and causing symptoms?
- Do you weigh more than 40 kg (about 6 stone 4 pounds) but less than 130 kg (about 20 stone 6 pounds), with a BMI of 45 or less?
- Have you had certain types of cancer or serious heart/blood clotting problems in the recent past (these might prevent you from joining)?
- Do you have an active or recent infection, or a high risk of shingles?
What does participation involve?
If you decide to take part in this study, you would primarily be taking a study medication, which will be either the active drug (brepocitinib) or a placebo (a dummy pill), both taken by mouth. You wouldn't know which one you are taking. You would need to attend several visits to the study clinic for assessments. These visits will likely involve physical examinations, discussions about your symptoms and any side effects, blood tests, and possibly photographs of your scalp or further biopsies to track your condition. The study team will monitor your health very closely throughout your participation.
The total length of your participation in the study, including the treatment period and follow-up, could vary, but clinical trials typically involve several months to over a year of regular visits. After you finish taking the study medication, there will usually be a follow-up period to monitor your health. The research team will give you a detailed schedule of visits and what each visit will involve.
Potential risks and benefits
Locations (61)
- Clinical Trial SiteVerified postcodeBirmingham, United States· Recruiting
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- Clinical Trial SiteVerified postcodeMiami, United States· Recruiting
- Clinical Trial SiteVerified postcodeChicago, United States· Recruiting
Common questions
What is lichen planopilaris (LPP)?
LPP is a condition that causes inflammation in the scalp, leading to itching, soreness, and often permanent hair loss.
What is brepocitinib?
Brepocitinib is a new medication being tested to see if it can help treat the inflammation and symptoms of LPP.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the new drug.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you are taking brepocitinib or the placebo.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and this will not affect your future medical care.
How to find out more
Clinical Trial Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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