A randomized, double-blind, placebo-controlled, proof of concept study assessing the efficacy and safety of an anti-TNF-OX40L NANOBODY® molecule, SAR442970, in participants with moderate to severe hidradenitis suppurativa
This research study is looking into a new medication called SAR442970 for people who have moderate to severe hidradenitis suppurativa (HS). This condition causes painful lumps and boils under the skin. The study wants to find out how well SAR442970 works to improve HS symptoms and reduce pain, and if it's safe to use. Half of the participants will receive SAR442970, and the other half will receive a 'dummy' treatment (placebo) that looks the same but contains no active medicine. Neither the participants nor the doctors will know who is getting which treatment until the study ends. This helps ensure the results are fair and accurate.
At a glance
What is this study about?
This study is a Phase II clinical trial, which means it's an important early step in testing a new medicine called SAR442970. The medicine is designed to treat hidradenitis suppurativa (HS), a long-term skin condition that causes painful abscesses, boils, and scarring, mostly in areas like the armpits and groin. The main goal is to see if SAR442970 is effective in reducing the impact of HS on people's lives and to check its safety.
To do this, some participants will receive the new medicine, while others will receive a 'placebo' – a dummy treatment that looks identical but has no active drug. This is a common and important way to test new medicines fairly, as it helps researchers understand if any improvements are due to the medicine itself or other factors. Neither you nor your study doctor will know which treatment you are getting. Researchers will carefully compare how both groups of people feel and how their HS symptoms change.
The study will especially look at how many participants experience a significant improvement in their HS symptoms, measured by something called the Hidradenitis Suppurativa Clinical Response (HiSCR50). This means a 50% or more reduction in certain types of HS lesions. They will also track how quickly these improvements happen, overall changes in the severity of HS, and how much pain people experience. Safety is also a top priority, so any side effects will be closely monitored.
Key takeaways
- This study is testing a new medicine, SAR442970, for moderate to severe HS.
- It's a Phase II trial, focusing on whether the medicine works and is safe.
- Participants will receive either the new medicine or a dummy treatment (placebo).
- People who haven't used certain immune-suppressing drugs before may be eligible.
- The study will closely monitor improvements in HS symptoms, pain, and any side effects.
- Participation involves regular clinic visits and health assessments.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
Crucially, you should not have previously taken certain types of strong medications that affect your immune system, known as 'biologics' or 'small molecule immunosuppressives'. This is because the study wants to understand how effective SAR442970 is on its own before people have tried these other treatments.
Further specific criteria will be checked by the study team, but generally, if you have moderate to severe hidradenitis suppurativa and haven't used those particular types of medicines before, you might be a suitable candidate.
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 moderate to severe hidradenitis suppurativa (HS)?
- Have you *not* taken biologic or small molecule immune-suppressing medicines for your HS before?
- Are you comfortable with regular clinic visits and various health assessments?
What does participation involve?
If you decide to take part in this study, you will be assigned to either receive the new medicine, SAR442970, or a placebo (dummy treatment). This will be decided randomly, like flipping a coin. You will have regular visits to the clinic where doctors and nurses will monitor your health, assess your HS symptoms, and record any changes. You'll likely have physical exams, blood tests, and scans. You'll also be asked to report on your pain levels and any side effects you might experience. The total duration of your participation in the study, including follow-up appointments, will be clearly explained by the study team.
Potential risks and benefits
Locations (11)
- —UnverifiedBelgium
- —UnverifiedNetherlands
- —UnverifiedSweden
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedPoland
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, boils, and abscesses, often in areas where skin rubs together like the armpits and groin.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to fairly compare a new medicine's effects.
What is a 'Phase II' study?
Phase II means it's an early stage of testing a new medicine. Researchers are looking to see if it works and to further check its safety in a small group of people.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor your doctor will know which treatment you are receiving. This is called 'double-blind' and helps make the study results more reliable.
What does 'HiSCR50' mean?
HiSCR50 is a way for doctors to measure if your HS symptoms have improved by 50% or more, based on specific criteria for lesions and abscesses.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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