A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa
This research study is looking for people aged 18 and over with moderate to severe hidradenitis suppurativa, a long-term skin condition causing painful lumps and abscesses. The main goal is to test a new investigational medicine called VAY736, to see how well it works and if it's safe. Participants will receive either the new medicine or a placebo (a dummy treatment that looks the same but has no active drug). Neither you nor your study doctor will know which one you are receiving. The study will check if patients' symptoms improve after 16 weeks of treatment. Researchers will also be carefully monitoring for any side effects.
At a glance
What is this study about?
This research study is focused on a skin condition called hidradenitis suppurativa, often shortened to HS. If you have HS, you might experience painful lumps, boils, or abscesses, usually in areas where skin folds, like the armpits or groin. These can be very uncomfortable and affect daily life. This particular study is for people who have a moderate to severe form of HS.
The main idea behind this study is to test out a new medicine, called VAY736. Scientists want to see how effective it is at reducing the symptoms of HS and whether it is safe to use. To do this fairly, some people in the study will receive the new medicine, while others will receive something called a placebo. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps researchers understand if any improvements seen are truly due to the new medicine or to other factors.
Throughout the study, doctors and nurses will closely monitor your health and your HS symptoms. They will specifically be looking at how many people show a 'clinical response' after 16 weeks, which means a noticeable improvement in their HS symptoms according to a specific measure. They will also be meticulously tracking any side effects or changes in your overall health to ensure your safety.
Key takeaways
- Tests a new medicine (VAY736) for moderate to severe hidradenitis suppurativa.
- Compares the new medicine to a placebo (dummy treatment).
- Aims to see if HS symptoms improve after 16 weeks.
- Includes regular health checks and monitoring for side effects.
- Open to adults aged 18 and over with HS.
Who may be eligible?
To join this study, you need to be at least 18 years old. There is no upper age limit, meaning people of all adult ages may be considered.
Both men and women are welcome to take part in this study. The study is particularly looking for people who have been diagnosed with moderate to severe hidradenitis suppurativa.
There might be other specific health requirements or conditions that could prevent someone from joining, even if they meet the age and gender criteria. These will be discussed in detail by the study team to make sure the study is right and safe for you.
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 moderate to severe hidradenitis suppurativa?
- Are you willing to potentially receive a placebo (dummy treatment)?
- Are you able to attend regular clinic visits for about 16 weeks and beyond?
What does participation involve?
If you decide to take part, you'll be given either the new study medicine (VAY736) or a placebo, which is a dummy treatment. You won't know which one you're getting, and neither will your doctor for a fair comparison. The medicine will be given as an injection or infusion.
Over the course of 16 weeks, you will have regular visits to the clinic so the study team can check on your health and how your hidradenitis suppurativa is responding. These visits will involve physical examinations, taking your vital signs like blood pressure, having blood tests (to check safety), and sometimes an ECG (a simple heart check). After the 16 weeks of treatment, there will likely be follow-up appointments to continue monitoring your health and any long-term effects. The total duration of your involvement will include the treatment period and follow-up.
Potential risks and benefits
Locations (6)
- —UnverifiedHungary
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedBelgium
Common questions
What is hidradenitis suppurativa?
It's a long-term skin condition that causes painful lumps, boils, or abscesses, often in skin folds like the armpits or groin.
What does 'placebo controlled' mean?
It means some people will get the new medicine, and others will get a dummy treatment (placebo) that looks the same but has no active drug, to fairly test the new medicine.
What is VAY736?
VAY736 is the investigational medicine being tested in this study to see if it can help improve hidradenitis suppurativa.
What is a 'clinical response'?
In this study, it means a noticeable improvement in your HS symptoms, as measured by specific medical criteria, after 16 weeks of treatment.
How long will I be in the study?
The main treatment period is 16 weeks, but your full involvement will include follow-up appointments after this.
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.