A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
This study is looking into a new medicine called lutikizumab for adults and teenagers (aged 12 and up) with moderate to severe hidradenitis suppurativa (HS). HS is a skin condition causing painful lumps and scars. Participants will receive injections of either lutikizumab or a dummy medicine (placebo) over several weeks. The main aim is to see how well lutikizumab works to improve HS symptoms and if it's safe to use. Everyone will eventually get the active medicine. Taking part means regular hospital visits for assessments, blood tests, and to record side effects in diaries. This helps researchers understand the potential benefits and risks of this new treatment.
At a glance
What is this study about?
This study, called a clinical trial, is looking at a new medicine named lutikizumab. It's designed for people who have a skin condition called hidradenitis suppurativa, or HS for short. HS can cause painful lumps, abscesses (pus-filled pockets), and scars in places like armpits, groin, and under the breasts. This trial wants to find out if lutikizumab can help reduce these symptoms and improve the lives of people with HS.
Researchers want to see if lutikizumab works better than a 'placebo', which is a dummy treatment with no active medicine. This helps them understand the true effect of lutikizumab. Around 1280 adults and teenagers with moderate to severe HS will take part in this study across many locations worldwide. The study will look closely at how the medicine affects the disease and whether it's safe.
The study is divided into different periods. In the first period, half of the participants will receive lutikizumab and the other half will receive the placebo. Later on, everyone will eventually receive lutikizumab, so no one will be on the placebo for the entire study. This setup helps scientists measure the medicine's effects carefully. By joining, you'll be helping doctors learn more about HS and potentially find new ways to treat it.
Key takeaways
- It's a study testing a new medicine (lutikizumab) for moderate to severe HS.
- Compares lutikizumab with a dummy medicine (placebo) at first.
- Open to adults and teenagers aged 12 and up.
- Involves regular injections and hospital visits.
- Aims to check effectiveness and safety of lutikizumab.
- Participants will eventually all receive the active medicine.
Who may be eligible?
To join this study, you would need to have been diagnosed with moderate to severe hidradenitis suppurativa (HS) for at least six months. This means your doctor has identified HS lesions (lumps and inflamed areas) in at least two different parts of your body, and that some of your HS is considered quite active.
There are also some reasons why you might not be able to join. For example, if you have certain infections like Hepatitis B or C, or HIV, or if you show signs of active tuberculosis, you wouldn't be able to participate. This helps keep everyone in the study safe.
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 12 years old or older?
- Have you been diagnosed with moderate to severe HS for at least 6 months?
- Do you have HS lumps and inflamed areas in at least two separate body areas?
- Do you have at least 5 active lumps or inflamed areas (abscesses/nodules)?
- Do you NOT have Hepatitis B or C, or HIV, or active tuberculosis?
What does participation involve?
If you decide to join this study, you'll be involved for a long time. You'll get the study medicine as injections just under your skin, initially once a week. This will be either lutikizumab or a dummy medicine (placebo) in the first phase of the study. After a few months, everyone will receive lutikizumab, either weekly or every other week.
You'll need to go to regular appointments at a hospital or clinic. These visits will involve various medical checks, blood tests, looking for any side effects, and filling out questionnaires and diaries. This helps the study team understand how the medicine is working and how you're feeling. The study involves several stages, with some participants potentially continuing for over three years (156 weeks) to assess the treatment's long-term effects. This is a bigger commitment than standard care but helps gather important information.
Potential risks and benefits
Locations (279)
- Cahaba Dermatology & Skin Health Center /ID# 263795Verified postcodeBirmingham, United States
- Medical Dermatology Specialists /ID# 263394Verified postcodePhoenix, United States
- Banner University Medicine Dermatology /ID# 263557Verified postcodeTucson, United States
- Dermatology Trial Associates /ID# 264587Verified postcodeBryant, United States
- Arkansas Research Trials /ID# 263901Verified postcodeNorth Little Rock, United States
- Private Practice - Dr. Tooraj Raoof /ID# 263756Verified postcodeEncino, United States
- Dermatology Research Associates - Los Angeles /ID# 263765Verified postcodeLos Angeles, United States
- Stanford University School of Medicine - Redwood City /ID# 263711Verified postcodeRedwood City, United States
- Norcal Clinical Research /ID# 279008Verified postcodeRocklin, United States
- Integrative Skin Science and Research /ID# 264600Verified postcodeSacramento, United States
- Clinical Trials Research Institute /ID# 263743Verified postcodeThousand Oaks, United States
- Yale University School of Medicine /ID# 263695Verified postcodeNew Haven, United States
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-lasting skin condition that causes painful lumps, abscesses, and scars, often in places where skin rubs together like the armpits or groin.
What is lutikizumab?
Lutikizumab is a new medicine being tested to see if it can help treat HS. It's an 'investigational drug,' meaning it's not yet approved for general use.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.
Will I definitely get the active medicine?
Eventually, yes. In the first part of the study, there's a 1 in 2 chance you'll get the placebo. However, everyone will receive lutikizumab in the later stages of the study.
How long will I be in the study?
The study involves different phases. Some participants may be involved for over three years to look at the long-term effects of the medicine.
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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