A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa – The CEDAR Study
The CEDAR study is a research project looking into a new medication called brensocatib for people aged 18 and over who have moderate to severe hidradenitis suppurativa (HS). This is a skin condition that causes painful lumps and abscesses. The study aims to see how well brensocatib works compared to a placebo, which is a dummy pill with no active medicine, and if it's safe to use. Half the participants will receive brensocatib, and the other half will receive the placebo. Doctors won't know who is getting what until the study ends. The main goal is to check if the new medicine helps reduce the number of painful lumps and swelling after 16 weeks.
At a glance
What is this study about?
This research study, called the CEDAR Study, is focused on finding new ways to help people living with hidradenitis suppurativa (HS). HS is a long-term skin condition that causes painful lumps, boils, and abscesses, most often in places where skin rubs together, like the armpits or groin. These can be very uncomfortable and affect daily life.
The study is testing a new medicine called brensocatib. Researchers want to understand if this new medicine can reduce the number of these painful skin problems in adults who have moderate to severe HS. It's a 'Phase 2b' study, which means it's an important step in developing new medicines. It aims to get a better idea of how well the medicine works and if it has any side effects, before it moves on to even larger studies.
To make sure the results are fair and accurate, some participants will receive brensocatib, and others will receive a 'placebo.' A placebo looks exactly like the real medicine but contains no active drug. Neither the patients nor their doctors will know who is getting which tablet until the study is over. This helps researchers truly see if brensocatib is making a difference rather than other factors. The main goal is to measure the change in the number of painful lumps and inflamed areas after 16 weeks of treatment.
Key takeaways
- Tests a new medicine (brensocatib) for moderate to severe HS.
- Compares the new medicine to a dummy pill (placebo).
- Focuses on reducing painful skin lumps and swelling.
- Participation involves clinic visits and taking daily medication for 16 weeks.
- Open to adults aged 18 and over with HS.
Who may be eligible?
This study is looking for adult volunteers to take part. To be considered, you need to be at least 18 years old – there's no upper age limit.
Both men and women are welcome to participate. The key requirement is that you have a diagnosis of moderate to severe hidradenitis suppurativa (HS).
There might be other specific health requirements or conditions that would prevent you from joining, but these would be discussed in detail by the study team if you express interest.
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 a diagnosis of moderate to severe hidradenitis suppurativa (HS)?
- Are you willing to attend regular clinic visits?
- Are you able to take study medication as instructed for 16 weeks?
What does participation involve?
If you join this study, you'll be given a study medication (either brensocatib or a placebo) to take regularly. You won't know which one you're receiving, and neither will your doctor, which is common in these types of studies to ensure fair results. You'll have several visits to the clinic over a period of 16 weeks, where the study team will monitor your health, check your skin, and record any changes in your HS symptoms, particularly the number of painful lumps and swollen areas. You may also be asked to provide blood samples or complete questionnaires. After the main 16-week treatment period, there will be follow-up observations to track your progress and safety. The total duration of your involvement, including follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedGreece
Common questions
What is hidradenitis suppurativa (HS)?
HS is a chronic skin condition causing painful lumps and boils, often in body folds like armpits or groin.
What is brensocatib?
Brensocatib is a new medicine being tested to see if it can help reduce the painful symptoms of HS.
What is a placebo?
A placebo is a 'dummy' pill that looks like the real medicine but contains no active drug. It helps compare the new medicine's effects fairly.
How long will the main treatment part of the study last?
The main treatment period where you take the study medication and have assessments is 16 weeks.
Can I choose which treatment I get?
No, you will be randomly assigned to either brensocatib or the placebo. Neither you nor your doctor will know which you are receiving.
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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