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-301)
This study is looking at a new medicine called sonelokimab. It's for adults who have hidradenitis suppurativa (HS) that is moderate to severe. The main aim is to see if sonelokimab helps improve HS symptoms more than a dummy treatment (placebo). Researchers will also be checking if the medicine is safe. Participants will receive either sonelokimab or the placebo as an injection under the skin. The study will look at how many people have a significant improvement in their HS at 16 weeks, and will also monitor how everyday life is affected, alongside any side effects.
At a glance
What is this study about?
This research study is about a new way to treat a skin condition called hidradenitis suppurativa, often shortened to HS. HS causes painful lumps, boils, and abscesses, usually in places where skin rubs together, like the armpits or groin. This study is testing a new medication called sonelokimab to see if it can help adults who have moderate to severe HS.
The study wants to find out two main things: firstly, if sonelokimab is effective at reducing the symptoms of HS, and secondly, if it is safe for people to use. To do this, some participants will receive sonelokimab, while others will receive a 'placebo', which looks exactly like the real medicine but contains no active drug. This helps researchers understand the true effects of the new medicine.
Researchers will specifically look at how many people experience a major improvement in their HS symptoms after 16 weeks of treatment. They will also check if the medicine improves quality of life, reduces pain, and carefully record any side effects that people might experience.
Key takeaways
- Tests a new medicine, sonelokimab, for moderate to severe HS.
- Compares sonelokimab to a dummy treatment (placebo).
- Looks mainly at symptom improvement after 16 weeks.
- Checks safety and how quality of life is affected.
- Participation involves regular clinic visits and assessments.
Who may be eligible?
This study is looking for adult volunteers aged 18 and over who have been diagnosed with hidradenitis suppurativa (HS). Your HS needs to be at a moderate to severe level for you to be considered for this study.
There might be other health conditions or medications that mean you wouldn't be able to join. For example, if you have certain other illnesses, or are taking particular medicines, this could affect whether you are suitable.
The research team will carry out a thorough check of your medical history to make sure the study is safe for you and that the results will be accurate.
- 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 able to attend regular clinic appointments?
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 will be randomly assigned to receive either the active study medicine, sonelokimab, or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you are receiving. The study medicine is given as an injection under the skin, using a pre-filled syringe.
Throughout the study, you will have regular visits to the clinic for assessments. These will include physical examinations, measuring your vital signs (like blood pressure and heart rate), taking blood and urine samples, and having ECGs (heart tests). You'll also be asked to complete questionnaires about your HS symptoms, pain levels, and how your quality of life is affected. The study will monitor any side effects you might experience. The total duration of your involvement will be explained by the study team, but key measurements will be taken at 16 weeks.
Potential risks and benefits
Locations (8)
- —Norway
- —Italy
- —Poland
- —Bulgaria
- —Austria
- —Portugal
- —Germany
- —Hungary
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps and boils, usually in areas where your skin rubs together.
What is sonelokimab?
Sonelokimab is a new medicine being tested to see if it can help treat moderate to severe HS.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers understand how well the actual medicine works.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving sonelokimab or the placebo. This helps ensure fair and accurate results.
How is the study medicine given?
The study medicine (sonelokimab or placebo) is given as an injection under the skin, using a pre-filled syringe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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