A Phase 2, randomized, double-blind, placebo-controlled, parallel group, proof-of-concept study assessing the efficacy and safety of amlitelimab in adult participants with moderate to severe hidradenitis suppurativa.
This important study is looking into a new medicine called amlitelimab for adults who have moderate to severe hidradenitis suppurativa, a long-term skin condition. It's a 'Phase 2' study, meaning researchers are trying to understand how well the medicine works and if it's safe. Some participants will receive the real medicine, while others will get a placebo (a dummy drug with no active ingredients) to make sure results are fair. Nobody, not even the doctors, will know who gets which until the study ends. The main goal is to see how many people show a significant improvement in their HS symptoms after 16 weeks of treatment with amlitelimab.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called amlitelimab for adults living with hidradenitis suppurativa (HS). HS is a chronic skin condition that causes painful lumps and abscesses. The study aims to find out if amlitelimab can help reduce these symptoms and improve the quality of life for people with HS.
This is a 'Phase 2' study, which means it's an early stage of testing. Researchers are trying to get a better understanding of how effective the medicine is and to check its safety profile. They'll be comparing amlitelimab to a 'placebo,' which is a treatment that looks exactly like the study drug but contains no active medicine. This helps ensure that any improvements seen are genuinely due to the amlitelimab and not just other factors.
The study is 'randomised' and 'double-blind.' This means that participants are randomly assigned to either receive amlitelimab or the placebo, like flipping a coin. Also, neither the participants nor their doctors will know whether they're getting the active drug or the placebo. This setup helps prevent any bias in the study results, ensuring the findings are as reliable as possible. The main thing they'll be looking for is a significant improvement in HS symptoms (called HiSCR50) after 16 weeks.
Key takeaways
- This study is testing a new medicine for moderate to severe hidradenitis suppurativa.
- It's an early-stage study to check effectiveness and safety.
- Some participants will receive the real medicine, others a dummy drug (placebo).
- Neither you nor your doctor will know which treatment you receive (double-blind).
- The main goal is to see how much improvement in HS symptoms occurs after 16 weeks.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
More specifically, they are looking for adults who have hidradenitis suppurativa (HS) that is considered moderate to severe. This means your HS symptoms are affecting your daily life significantly. There will be specific medical checks to confirm your HS severity and overall health, to make sure the study is right for you and safe.
The research team will also look at your full medical history and current medications to see if there's anything that might prevent you from safely taking part in the study. It's important to be completely honest about your health and any other treatments you're receiving.
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 hidradenitis suppurativa (HS)?
- Is your HS considered moderate to severe by your doctor?
- Are you willing to attend regular clinic visits for 16 weeks and beyond?
- Are you comfortable with the possibility of receiving a placebo instead of the active drug?
What does participation involve?
If you decide to participate, you will be randomly assigned to either receive the study medicine (amlitelimab) or a dummy treatment (placebo). Neither you nor your doctor will know which one you are receiving during the study. You'll take the treatment for 16 weeks.
During these 16 weeks, you'll have several visits to the clinic. At these visits, doctors will regularly monitor your hidradenitis suppurativa symptoms and check how you're feeling. This will involve physical examinations, taking blood and urine samples, and asking you to fill out questionnaires about your pain, itching, and how your HS affects your daily life.
They will also monitor for any side effects and ensure your overall health is stable. After the 16-week treatment period, there will be follow-up visits to continue tracking your health and any long-term effects of the treatment. The exact number of visits and their frequency will be explained in detail by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedPortugal
- —UnverifiedItaly
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, abscesses, and scarring, typically in areas where skin rubs together, like armpits and groin.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
What does 'double-blind' mean?
It means neither you nor your study doctor will know whether you are receiving the active medicine or the placebo during the trial. This helps make the study results more reliable.
How long will the study treatment last?
The main treatment period for this study is 16 weeks.
Will I have to pay to be in the study?
No, you should not have to pay to participate in the clinical trial. Any study-related treatments and assessments are usually covered by the study sponsor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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