A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
This study is about a new medicine, Zasocitinib, for adults with Hidradenitis Suppurativa (HS). HS is a skin condition that causes deep, painful bumps, especially in areas where skin rubs together. These bumps can swell, become red, and sometimes fill with pus, leading to abscesses that can burst. Over time, this can result in scars and tunnels under the skin. It's thought that HS might start when hair follicles get blocked, triggering the body's immune system and allowing bacteria to grow, making the condition worse. This study aims to find out how safe Zasocitinib is, how well it helps, and if people can take it without too many problems, compared to a dummy pill (placebo).
De un vistazo
¿De qué trata este estudio?
This study is focused on a skin condition called Hidradenitis Suppurativa, or HS for short. HS causes painful, deep bumps on the skin, often in places where skin rubs together, like armpits or groin. These bumps can start small but become swollen, red, and sometimes fill with pus, forming what are called abscesses. When these abscesses burst, they can be quite uncomfortable, and over time, the affected skin can develop scars and even tunnels beneath the surface.
Recent research suggests that HS might begin when hair follicles (the tiny pockets in your skin where hair grows) become damaged and blocked. This blockage can then irritate the skin and activate your body's immune system, which is its way of fighting off germs. When this happens, bacteria can grow more easily on the skin, making the condition worse and leading to those uncomfortable abscesses.
The main goal of this particular study is to test a new medicine called Zasocitinib. We want to see how safe Zasocitinib is, how effectively it treats HS, and how well people can tolerate taking it. To do this, some participants will receive Zasocitinib, while others will receive a placebo, which is a pill that looks exactly like Zasocitinib but contains no active medicine. We hope to learn if Zasocitinib can be a helpful new treatment option for adults living with HS.
Puntos clave
- This study is testing a new medicine called Zasocitinib for adults with Hidradenitis Suppurativa (HS).
- It aims to find out if Zasocitinib is safe, effective, and well-tolerated.
- Participants will receive either Zasocitinib or a dummy pill (placebo) for the first 4 months, then everyone gets Zasocitinib for 8 more months.
- You'll have regular visits (12 in total) to the clinic over approximately a year.
- You must have had HS for at least 6 months and tried antibiotics for it without success.
- Participation is voluntary, and you can leave the study at any time.
¿Quién puede ser elegible?
To join this study, you need to be an adult, aged 18 or older. It's important that you've had symptoms of Hidradenitis Suppurativa (HS) for at least six months before the study starts, and a skin doctor (dermatologist) must have confirmed your HS diagnosis. Your HS symptoms should have been stable for about two months before joining.
You also need to have HS affect at least two different parts of your body, and at least one of these areas should have more serious symptoms, as judged by the study doctor. You should also have at least five active inflamed bumps (abscesses or painful lumps) when you join. Additionally, you must have tried an oral antibiotic for your HS in the past, but it didn't work well enough, or you couldn't take it due to side effects or other reasons.
There are also some requirements about birth control for people who could become pregnant, to make sure everyone is safe during the study. The study doctors will discuss all these details with you carefully to see if this study is suitable for you.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- Has a skin doctor (dermatologist) confirmed you have HS?
- Have you had HS symptoms for at least 6 months?
- Do you have HS in at least two different body areas?
- Do you currently have at least 5 active inflamed bumps (abscesses or nodules)?
- Have you tried an oral antibiotic for your HS before, but it didn't work well or you couldn't tolerate it?
¿En qué consiste la participación?
If you decide to take part in this study, you will first receive either the study medicine, Zasocitinib, or a dummy pill (placebo) for about 4 months (16 weeks). The placebo looks just like the real medicine but contains no active ingredients. After these first 4 months, everyone in the study, including those who initially received the placebo, will then take Zasocitinib for up to 8 additional months (36 weeks).
During the study, you will need to visit the study clinic 12 times in total. These visits will allow the study team to monitor your health, check how your HS is responding to the treatment, and ask about any side effects you might be experiencing. The total time you would be involved in the study could be up to 12 months.
Riesgos y beneficios potenciales
Locations (49)
- Mayo ClinicCódigo postal verificadoScottsdale, Estados Unidos· Aún no reclutando
- Johnson DermatologyCódigo postal verificadoFort Smith, United States· Reclutamiento
- First OC Dermatology ResearchCódigo postal verificadoFountain Valley, Estados Unidos· Reclutamiento
- Direct Helpers Research CenterCódigo postal verificadoHialeah, Estados Unidos· Aún no reclutando
- Advanced Clinical Research InstituteCódigo postal verificadoTampa, Estados Unidos· Reclutamiento
- Beth Israel Deaconess Medical CenterCódigo postal verificadoBoston, Estados Unidos· Aún no reclutando
- Wayne State UniversityCódigo postal verificadoDetroit, Estados Unidos· Aún no reclutando
- Hamzavi DermatologySolo ciudadFort Gratiot, United States· Reclutamiento
- StracSkin, PLLCCódigo postal verificadoGreenland, United States· Reclutamiento
- Northwell Health Physician PartnersCódigo postal verificadoLake Success, Estados Unidos· Aún no reclutando
- Mount Sinai DoctorsCódigo postal verificadoNueva York, Estados Unidos· Aún no reclutando
- Apex Clinical Research Center, LLC.Código postal verificadoMayfield Heights, United States· Aún no reclutando
Preguntas comunes
What is Hidradenitis Suppurativa (HS)?
HS is a long-term skin condition causing painful bumps, spots, and abscesses (boils) in areas where skin rubs together, like armpits, groin, or under the breasts.
What is Zasocitinib?
Zasocitinib is a new medicine being tested to see if it can help improve HS symptoms and is safe for people to take.
¿Qué es un 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects.
¿Cuánto tiempo estaré en el estudio?
You will be in the study for up to 4 months on either Zasocitinib or placebo, followed by up to 8 more months on Zasocitinib, for a total of up to 12 months.
Are there any costs for joining?
You should not have to pay for any study-related medicines or appointments.
Cómo obtener más información
Takeda Contact
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.