Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
Doctors are studying a new drug called brivekimig for people with moderate to severe hidradenitis suppurativa (HS). This study, called a Phase 2 trial, aims to find out if brivekimig is effective and safe. Participants will be given either brivekimig or a placebo (a dummy medicine with no active drug) to see if it helps improve their HS. Everyone involved, including the patients and doctors, won't know who is getting the real drug until the study is over. The study will also test different doses of brivekimig. This research is important to find better ways to manage HS symptoms.
Överblick
Vad handlar denna studie om?
This study is looking into a new medicine called brivekimig for people who have moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition that causes painful lumps, boils, and abscesses. The main goal of this research is to see if brivekimig can help reduce these symptoms and whether it's safe to use.
To find this out, some people in the study will receive brivekimig, and others will receive a 'placebo' – which looks like the real medicine but contains no active drug. This allows the researchers to fairly compare the effects of brivekimig. Neither you nor your study doctor will know whether you are getting the real medicine or the placebo, which helps make sure the results are unbiased. The study will also help doctors figure out the best dose of brivekimig to use.
This kind of study, called a Phase 2 trial, is a crucial step in developing new medicines. It helps us understand more about how the drug works, its potential benefits, and any side effects. By taking part, you could be helping to find a new treatment option for people living with HS.
Viktiga punkter
- Tests a new medicine (brivekimig) for moderate to severe HS.
- Compares brivekimig to a dummy medicine (placebo).
- Aims to check safety and how well it reduces HS symptoms.
- Study lasts up to about 60 weeks.
- You won't know if you're getting the active drug or placebo.
Vem kan vara berättigad?
To join this study, you need to have been diagnosed with moderate to severe hidradenitis suppurativa (HS) for at least 6 months. Your HS must affect at least two different body areas, and at least one of these areas must be quite severe (Hurley Stage II or III). You also need to have tried and not responded well to oral antibiotics for your HS, or couldn't take them for some reason.
You might be able to join if you haven't taken 'biologic' medicines before for your HS, or if you have tried them. At the start of the study, you should have at least 5 painful lumps or inflamed nodules, and no more than 20 draining tunnels (tunnels under the skin that release pus or fluid).
However, you cannot join if you have other serious skin conditions that might make it hard to tell if the HS is improving, or if you have a history of serious infections, weakened immune system, previous organ or stem cell transplants, or certain heart problems. You also can't participate if you have a history of specific neurological conditions or certain types of cancer that haven't been fully treated.
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.
- Do I have moderate to severe HS diagnosed for at least 6 months?
- Does my HS affect at least two body areas, with one being quite severe?
- Have I tried oral antibiotics for HS but they didn't work well, or I couldn't take them?
- Do I have at least 5 painful lumps/inflamed nodules and no more than 20 draining tunnels?
- Do I have any other serious health conditions like severe heart failure or a weakened immune system?
Vad innebär deltagande?
If you decide to take part in this study, your involvement could last for just under a year, specifically up to about 60 weeks. However, if you are invited to continue into a longer-term part of the study, your initial participation might be shorter, around 52 weeks.
Throughout the study, you'll have regular visits to the clinic where you'll be given the study medicine (either brivekimig or placebo). The main treatment period, where you'll receive the study drug, will last for up to about 48 weeks. During these visits, the study team will carefully check your HS symptoms, ask about your general health, and carry out tests to make sure the medicine is safe and working as expected.
Potentiella risker och fördelar
Platser (85)
- Medical Dermatology Specialists- Site Number : 8400019Verifierat postnummerPhoenix, USA· Rekrytering
- Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014Verifierat postnummerScottsdale, USA· Rekrytering
- Northridge Clinical Trials - Northridge- Site Number : 8400005Verifierat postnummerNorthridge, USA· Rekrytering
- Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001Verifierat postnummerFort Myers, USA· Rekrytering
- FXM Clinical Research - Miami- Site Number : 8400017Verifierat postnummerMiami, USA· Rekrytering
- FXM Clinical Research - Miramar- Site Number : 8400004Verifierat postnummerMiramar, United States· Rekrytering
- Advanced Medical Research - Atlanta- Site Number : 8400011Verifierat postnummerAtlanta, USA· Rekrytering
- Georgia Skin & Cancer Clinic- Site Number : 8400009Verifierat postnummerSavannah, USA· Rekrytering
- The Iowa Clinic West Des Moines Campus- Site Number : 8400007Verifierat postnummerWest Des Moines, United States· Rekrytering
- Louisiana Dermatology Associates- Site Number : 8400006Verifierat postnummerBaton Rouge, United States· Rekrytering
- Washington University- Site Number : 8400010Verifierat postnummerSt Louis, USA· Rekrytering
- JDR Dermatology Research- Site Number : 8400012Verifierat postnummerLas Vegas, USA· Rekrytering
Vanliga frågor
What is brivekimig?
Brivekimig is a new medicine being tested to see if it can help people with moderate to severe hidradenitis suppurativa (HS).
Vad är en placebo?
A placebo is a dummy medicine that looks just like the real drug but contains no active ingredients. It helps doctors compare the real drug's effects.
Kommer jag att veta om jag får den riktiga medicinen eller placebo?
No, both you and your study doctor won't know which you are receiving until the study is finished. This helps to keep the study fair and accurate.
Hur länge kommer jag att vara med i studien?
Your involvement could last up to about 60 weeks, or around 52 weeks if you join a longer-term part of the study afterwards.
Kan jag sluta delta om jag vill?
Yes, you are free to leave the study at any time, and it won't affect your regular medical care.
Hur du får reda på mer
Trial Transparency email recommended (Toll free for US & Canada)
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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