A parallel-group treatment, Phase 2, double-blind, placebo controlled study to evaluate the efficacy and safety of SAR444656 in adult participants with moderate to severe hidradenitis suppurativa.
This research study is looking at a new drug called SAR444656 for people who have moderate to severe hidradenitis suppurativa, often called HS. HS is a long-term skin condition that causes painful lumps, boils, and scarring. The main goal of this study is to find out if SAR444656 is effective in reducing these painful skin problems and if it's safe to use. Half of the people taking part will receive the new drug, while the other half will receive a dummy medicine (a placebo). This is a common way to properly compare the effects of the new treatment. Researchers will carefully watch for any changes in skin lumps and how participants feel, including any side effects, throughout the study.
At a glance
What is this study about?
Hidradenitis suppurativa (HS) is a long-lasting skin condition that causes painful lumps, boils, and sometimes channels under the skin, often in areas where skin rubs together, like the armpits or groin. It can be very uncomfortable and affect daily life. Treatment for HS isn't always easy, and doctors are always looking for new and better ways to help people manage their symptoms.
This study is testing a new medicine called SAR444656. It's a Phase 2 study, which means it’s one of the earlier stages of testing. At this point, we're trying to get a better idea of how well the medicine works and if it has any unwanted side effects when used by people with HS. The researchers will be looking closely at how the medicine affects the number of sore lumps and spots people have, and whether it makes a difference to their pain levels and overall quality of life.
To make sure the study results are as clear and accurate as possible, it's called a 'double-blind, placebo-controlled' study. This means that neither you nor your study doctor will know whether you are receiving the new medicine or a dummy treatment (placebo). This helps make sure everyone is treated the same way and that any changes observed are truly due to the medicine and not expectations. Once the study is over, the researchers will compare the results from both groups to see if SAR444656 is a promising new treatment for HS.
Key takeaways
- This study tests a new medicine for moderate to severe hidradenitis suppurativa (HS).
- It aims to see if the medicine is safe and reduces painful HS symptoms.
- Participants will either receive the new medicine or a dummy medicine.
- Both participants and doctors won't know who gets which treatment.
- Close medical monitoring will be provided throughout the study.
- Your pain levels and skin lumps will be regularly checked.
Who may be eligible?
To be able to take part in this study, you need to be an adult, meaning you are 18 years old or older. There is no upper age limit for joining.
The study is open to both men and women. The researchers will also have some other specific health requirements for you to meet to ensure your safety in the study and that the results they get are reliable. These will be discussed with you by the study team.
It's important that you have a diagnosis of moderate to severe hidradenitis suppurativa. If your HS symptoms are very mild or very severe, this study might not be the right fit for you. The study team will check your medical history and current health to see if you meet all the necessary criteria.
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 18 years old or older.
- I have been diagnosed with hidradenitis suppurativa.
- My hidradenitis suppurativa is considered moderate to severe.
- I am prepared to attend regular clinic visits.
- I am willing to potentially receive a dummy medicine instead of the new drug.
What does participation involve?
Taking part in this study would involve regularly visiting the study clinic. These visits will allow the medical team to monitor your health, check for any improvement in your HS, and look for any side effects. You will receive either the investigational medicine or a dummy pill (placebo) according to the study plan. You'll likely have blood tests, physical examinations, and answer questions about your pain and how you're feeling. You'll also be asked to keep track of your daily worst pain using a special scale. The total time you'll spend in the study and how often you need to attend visits will be clearly explained by the study team before you decide to join. There will also be a follow-up period after you stop taking the study medication to make sure you are well.
Potential risks and benefits
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Common questions
What is hidradenitis suppurativa?
It's a long-lasting skin condition causing painful lumps, boils, and spots, often in areas like armpits or groin.
What is a 'Phase 2' study?
It's an early stage of testing a new medicine to see if it's safe and how well it works before it can be widely used.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you're getting the new medicine or a dummy pill, to make the results fair.
Will I definitely get the new medicine?
No, you have a 50/50 chance. Half of the participants get the active medicine, and half get a dummy medicine (placebo).
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your 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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