A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-302)
This important study is looking into a new treatment called sonelokimab for adults living with moderate to severe hidradenitis suppurativa (HS). It's designed to see if sonelokimab is both safe and effective. Participants will randomly receive either sonelokimab or a placebo (a dummy treatment that looks the same but has no active medicine) for 16 weeks. Researchers will carefully check how well the treatment reduces HS symptoms and monitor for any side effects. This type of study, called a Phase 3 trial, is a crucial step before a new medicine can be considered for wider use, helping us understand if it can make a real difference for people with HS.
At a glance
What is this study about?
Hidradenitis suppurativa (HS) is a long-term skin condition that causes painful lumps and boils, often in areas where skin rubs together, like the armpits or groin. These can sometimes break open, leading to scars and infection. Living with HS can be very challenging and impact daily life significantly.
This study, named M1095-HS-302, is a Phase 3 clinical trial. This means it's one of the final stages of testing a new medicine before it can be considered for approval. The new medicine being tested is called sonelokimab, and it's given as an injection under the skin. We want to find out if sonelokimab can help improve the symptoms of HS, making it less severe for people who have it.
The study aims to compare sonelokimab with a placebo, which is a 'dummy' treatment that contains no active medicine. This comparison is vital because it helps researchers understand if any improvements seen are genuinely due to the new medicine or if they might happen anyway. All medicines can have side effects, so researchers will also be carefully monitoring the safety of sonelokimab throughout the study.
Key takeaways
- This study evaluates sonelokimab for moderate to severe HS.
- It's a Phase 3 study, comparing sonelokimab to a dummy treatment (placebo).
- The main goal is to see how well the medicine improves HS symptoms over 16 weeks and if it's safe.
- Participants will receive injections under the skin and have regular health checks.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women can take part.
You would need to have moderate to severe hidradenitis suppurativa (HS). This usually means you've had HS for some time and it's impacting your life significantly, and your doctor would confirm that your HS meets the study's specific criteria.
There might be other health conditions or medicines you are taking that would mean this study isn't right for you. The study team will discuss all of these details with you during a screening visit to make sure it's safe and appropriate for you to participate.
- Are you 18 years old or older?
- Have you been diagnosed with moderate to severe hidradenitis suppurativa (HS)?
- Are you prepared to attend regular study visits for 16 weeks and follow-up?
- Are you able to give informed consent (understand and agree to take part)?
- Are you willing to receive injections under the skin regularly?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would be randomly assigned to one of two groups: one receiving sonelokimab or one receiving the placebo (a dummy medicine). You wouldn't know which one you're getting, and neither would the study team, until the study is over. This helps ensure fair results.
The medicine is given as an injection under the skin, similar to how some people with diabetes take insulin. You would have regular visits to the clinic over a period of 16 weeks. During these visits, the study team would monitor your hidradenitis suppurativa, check your overall health through physical exams, blood and urine tests, and ask you questions about your symptoms and how you're feeling. They will also keep a close eye on any side effects you might experience. After the 16-week treatment period, there will be follow-up visits to continue monitoring your health.
Potential risks and benefits
Locations (10)
- —Netherlands
- —Slovakia
- —Czechia
- —France
- —Bulgaria
- —Spain
- —Poland
- —Ireland
- —Belgium
- —Germany
Common questions
What is hidradenitis suppurativa (HS)?
HS is a chronic skin condition causing painful bumps and boils, often in body folds like armpits or groin.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used for comparison.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor the study team will know during the study. This is called 'double-blind' to keep results fair.
How is the study medicine given?
The medicine is given as an injection under the skin, using a pre-filled syringe.
What does 'Phase 3' mean for a clinical trial?
Phase 3 is a late-stage trial, confirming safety and effectiveness in a larger group of people before a medicine can be considered for approval.
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.