A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Hidradenitis suppurativa is a long-term skin condition that causes painful boils, lumps, and scarring, usually around the armpits, groin, and buttocks. Current treatments do not work well for everyone, so researchers are searching for better options. This clinical study is testing a new medicine called eltrekibart in adults with moderate to severe symptoms. Researchers want to find out how well it works and how safe it is compared with an inactive substance known as a placebo. A placebo looks like the real treatment but contains plain salt water. Participants will receive either eltrekibart or the placebo. Doctors will track their skin changes over 16 weeks to see if the medicine reduces painful swelling and lumps by at least half. Taking part helps doctors learn whether this medicine could become a helpful future treatment.
Överblick
Vad handlar denna studie om?
Hidradenitis suppurativa is a painful, long-lasting condition that causes inflamed lumps, sores, and abscesses to form in areas where skin rubs together, such as under the arms or around the groin. These lumps can burst, leak fluid, and leave deep scars. Living with this condition can be physically uncomfortable and emotionally challenging, and many people struggle to find a treatment that brings lasting relief.
This trial is looking at an experimental medicine called eltrekibart. It is designed to calm down the body's immune signals that cause inflammation in the skin. The main goal is to discover whether eltrekibart can significantly reduce the number of painful bumps and flare-ups compared to a harmless dummy treatment, also known as a placebo.
This is a Phase 2 study, which means the medicine has already passed early safety checks in smaller groups of people. Researchers now need to test it in a larger group of adults to see how well it works and to watch closely for any side effects. The results could help scientists develop better, more targeted therapies for people living with hidradenitis suppurativa in the future.
Viktiga punkter
- The study tests a new medicine called eltrekibart for moderate to severe hidradenitis suppurativa.
- It aims to see if the drug can reduce painful skin lumps and swelling by half over 16 weeks.
- Participants are randomly chosen to receive either eltrekibart or a salt-water placebo.
- Open to adults aged 18 and older with active symptoms.
- Att delta är frivilligt, och du kan dra dig ur när som helst.
Vem kan vara berättigad?
This study is open to adults aged 18 and over who have been diagnosed with moderate to severe hidradenitis suppurativa. Both men and women are welcome to take part.
To join, participants generally need to have active skin lumps and sores that are not well controlled by standard skin washes or basic antibiotics. You will need to attend regular clinic appointments so the study doctors can check your skin and health.
People who are currently managing certain other severe medical conditions, active serious infections, or who are taking specific medicines that affect the immune system may not be able to join. The clinic team will review your full medical history to make sure taking part is safe for you.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am at least 18 years old.
- I have been diagnosed with hidradenitis suppurativa.
- My skin condition is currently moderate to severe with active, painful lumps.
- I am willing to attend regular hospital check-ups and skin assessments.
- I am open to receiving either the study medicine or a dummy treatment (placebo).
Vad innebär deltagande?
If you take part, you will be placed into one of two groups by chance, like flipping a coin. One group receives the study medicine, eltrekibart, while the other receives a placebo made of sterile salt water. Neither you nor the study team will know which one you are receiving during the main study period. The treatment is given at set times throughout the study.
You will attend regular hospital or clinic visits over several months, with key skin checks taking place around week 16. During these visits, doctors will examine your skin, count any active lumps, take blood and urine samples, and ask about your symptoms and quality of life. The full study duration, including health check-ups before starting and safety visits after finishing the medicine, will be explained in detail by the research team.
Potentiella risker och fördelar
Platser (3)
- —ObekräftadTyskland
- —ObekräftadPolen
- —ObekräftadGrekland
Vanliga frågor
Vad är en placebo?
A placebo is a harmless dummy treatment that looks just like the real medicine but contains no active drug. In this study, it is a simple salt water solution. It helps researchers prove whether the new medicine really works.
Do I have to pay to take part?
No, clinical trials in the UK do not cost you anything. The study medicine and all trial-related tests are provided free of charge, and travel expenses are often covered.
Can I choose to receive the real medicine instead of the placebo?
No. A computer assigns participants to either eltrekibart or the placebo by chance. This ensures the results of the trial remain fair and unbiased.
Can I carry on seeing my regular GP or dermatologist?
Yes. Your usual healthcare team will be kept informed, and you can continue seeing them for your routine medical care.
Vad händer om jag ändrar mig under studien?
You can leave the study at any point without giving a reason. Your doctors will make sure you move safely back to your standard treatments.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Intresserad av att delta?
Diskussion
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