Adalimumab Treatment for Patients with Hidradenitis Suppurativa at high risk of Progressing to Severe Disease: An Unblinded Randomized, Controlled Trial
Hidradenitis suppurativa (HS) is a long-term skin condition that causes painful lumps, boils, and scarring, usually in areas like the armpits and groin. Some people are at higher risk of their condition becoming severe over time. This trial aims to find out if using a biological medicine called adalimumab early on can stop HS from worsening. Participants will be placed into one of two treatment groups. One group receives adalimumab, which works by reducing inflammation in the immune system. The other group receives usual standard care, which may include an antibiotic called doxycycline and a medicated cream called resorcinol. Over two years, doctors will monitor participants to see which approach works best at keeping the skin clear and preventing severe flare-ups. Taking part helps researchers find better ways to protect people from long-term skin damage.
At a glance
What is this study about?
Hidradenitis suppurativa (HS) can be an uncomfortable and distressing skin condition. It leads to recurrent, painful swellings and abscesses that can break open and leave deep scars under the skin. For many people, the condition starts off mild or moderate, but over time it can worsen and become much harder to treat.
At the moment, standard care often relies on long courses of antibiotic tablets and creams applied to the skin. While these can help manage symptoms, they do not always stop the condition from advancing. Adalimumab is a specialised medicine that targets a specific protein involved in body inflammation. It is already used for severe HS, but researchers want to know if giving it sooner to people at high risk can stop severe disease from developing in the first place.
In this study, doctors are comparing adalimumab directly against standard treatments over a two-year period. By tracking how participants' skin changes over time, the trial aims to show whether earlier, targeted treatment can prevent deep tunnels, severe sores, and lasting tissue damage, ultimately improving long-term quality of life.
Key takeaways
- The study tests whether the medicine adalimumab can stop hidradenitis suppurativa from becoming severe.
- It compares adalimumab against standard care, which includes antibiotics and creams.
- The trial lasts for two years and includes approximately 10 hospital or clinic visits.
- It is open to adults aged 18 and over with non-severe HS who are at risk of disease progression.
- Taking part is completely voluntary and you can withdraw at any point.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with hidradenitis suppurativa. To take part, your condition must currently be considered non-severe, but your doctor must have identified that you are at a higher risk of it progressing to a severe stage.
Both men and women can join. Because the study focuses on preventing severe disease, people whose HS has already reached an advanced, severe stage—such as having widespread interconnected tunnels under the skin—may not be suitable for this specific trial.
Other general health conditions and current medications will also be checked by the study team to make sure it is completely safe for you to take part. A member of the research team can talk you through the full medical checklist.
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.
- I am aged 18 or over.
- I have been diagnosed with hidradenitis suppurativa (HS).
- My HS is not currently classed as severe.
- My doctor has told me my skin condition is at risk of worsening.
- I am able to attend regular clinic appointments over a two-year period.
What does participation involve?
If you decide to take part, you will be randomly assigned to one of two treatment groups. One group will take adalimumab, which is given as an injection under the skin. The other group will receive standard NHS care, which may involve taking doxycycline antibiotic tablets by mouth and using resorcinol cream on the skin.
You will be in the study for about two years (104 weeks). During this time, you will attend roughly 10 clinic visits. At these visits, the study team will examine your skin, count any lumps or boils, and ask you how your symptoms are affecting your day-to-day life. You will also have regular routine checks, such as blood tests, to ensure the treatment is safe for you.
Potential risks and benefits
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Common questions
What is adalimumab?
Adalimumab is a biologic medicine that calms down the immune system by blocking a specific protein that causes painful inflammation in your skin.
How is the medicine given?
Adalimumab is given as a gentle injection under the skin, usually into the thigh or tummy. The study nurses will show you how to do this safely at home.
Will I definitely get the new treatment?
No. A computer randomly decides whether you receive adalimumab or standard care (antibiotics and creams), giving each person a fair chance of being in either group.
Will I have to pay to take part?
No, all study-related treatments, clinic visits, and health checks are provided free of charge, and you may be able to claim back travel expenses.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without giving a reason, and your normal healthcare will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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