A Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa
This research is investigating a treatment named secukinumab for individuals living with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. The study focuses on participants who have already responded well to secukinumab in earlier trials. Researchers want to understand how long the positive effects of secukinumab last and how safe and well-tolerated it is over a longer period. Some participants will continue with secukinumab, while others will switch to a placebo (a dummy treatment) to help scientists understand the long-term benefits and possible side effects. The main goal is to see how much time passes before someone's HS symptoms worsen again.
At a glance
What is this study about?
This study is a continuation of previous research looking into a medicine called secukinumab for a skin condition called hidradenitis suppurativa, often shortened to HS. HS is a long-term condition that causes painful lumps, boils, and abscesses under the skin, mainly in areas like the armpits and groin. This particular study is for people who have already been taking secukinumab in an earlier trial and whose HS symptoms have improved. It's designed to see if the medicine continues to help them over a longer time, going up to two years.
The main aim is to understand how long it takes for a person's HS symptoms to get worse again after they've shown improvement. To do this, some people will continue to receive secukinumab, while others will be given a placebo, which looks like the medicine but contains no active drug. This is often done to compare the effects of the active medicine more clearly. The researchers will be closely monitoring any changes in their symptoms, looking especially at new lumps and painful spots.
Besides tracking how long the positive effects last, the study will also keep a close eye on the safety of secukinumab over this longer period. This means carefully recording any side effects people experience, checking important health measurements like blood tests and blood pressure, to ensure the medicine is still safe to use. This kind of study, called a Phase III trial, is often one of the last steps before a new medicine can be widely approved for use, as it helps confirm its benefits and safety for many patients.
Key takeaways
- This study is for adults with moderate to severe hidradenitis suppurativa (HS).
- It's an extension for those who previously responded well to secukinumab treatment.
- The main goal is to understand how long secukinumab's positive effects last.
- It will also track the long-term safety and side effects of the medicine.
- Some participants will continue with secukinumab, while others will receive a placebo for comparison.
Who may be eligible?
This study is looking for adults aged 18 years and older. There is no upper age limit, meaning older adults are welcome to participate as long as they meet other study requirements.
Participants must have been involved in earlier studies of secukinumab for hidradenitis suppurativa (HS) and have shown good improvement in their symptoms by the 52-week mark of those core studies. This means their HS symptoms, particularly the number of abscesses and inflammatory nodules, must have reduced by at least 50% without an increase in other specific symptoms.
If you're unsure whether you meet these criteria, it's best to discuss this with your doctor or the study team. They can help you understand all the requirements and determine if this particular research study might be suitable 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?
- Do you have moderate to severe hidradenitis suppurativa?
- Have you previously taken part in a secukinumab study for HS?
- Did your HS symptoms improve by at least 50% in the earlier study (after 52 weeks)?
- Are you willing to have regular injections and clinic visits for up to two years?
What does participation involve?
If you join this study, your participation will involve continuing treatment for your hidradenitis suppurativa. Since this is an 'extension' study, you would have already participated in an earlier trial of secukinumab. During this phase, you will either continue to receive regular doses of secukinumab or switch to a placebo (a dummy medicine) through injections under the skin. You will have scheduled visits to the clinic where study staff will check your health, assess your HS symptoms, and record any side effects you might be experiencing. These assessments will involve counting specific skin lesions like abscesses and nodules. You'll also have blood tests, blood pressure checks, and other routine examinations. The study aims to follow participants for up to 104 weeks (about two years) from when this extension study begins to see how your condition progresses and how well the treatment is working long-term. You will be closely monitored throughout this period.
Potential risks and benefits
Locations (14)
- —UnverifiedAustria
- —UnverifiedCroatia
- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedSlovakia
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedLithuania
- —UnverifiedNetherlands
- —UnverifiedBulgaria
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, boils, and abscesses, typically in areas where skin rubs together, like armpits and groins.
What is secukinumab?
Secukinumab is a medicine given by injection under the skin that targets a specific part of the body's immune system to reduce inflammation associated with conditions like HS.
What does 'placebo' mean in a study?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the true effects of the active medicine.
What is the main thing the study is looking for?
The study's main goal is to see how long it takes for someone's HS symptoms to start getting worse again after they've responded well to secukinumab in an earlier study.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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