A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This study is testing a new medication, SAR445399, for adults who have troublesome skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps and boils, often in areas like the armpits and groin. The study wants to find out if this new medicine is safe and helps to improve HS symptoms. Participants will be given either the new medicine or a dummy treatment (a placebo) to see if the medicine works better. The study is also trying to figure out the right amount (dose) of the medicine to use. It's a phase 2 study, meaning it's still in the earlier stages of research, checking for effectiveness and safety in a larger group of people.
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¿De qué trata este estudio?
This study is looking into a new treatment called SAR445399 for a skin condition called Hidradenitis Suppurativa (HS). HS is a long-term (chronic) condition that causes painful lumps, boils, and scarring, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. Living with HS can be very challenging and impact daily life significantly.
The researchers want to see if SAR445399 can help improve the symptoms of moderate to severe HS and if it's safe to use. To do this, some participants will receive SAR445399, while others will receive a 'placebo' – this is an inactive substance that looks just like the real medicine but has no medical effect. This is a common way to test new medicines, as it helps doctors understand if any changes are truly due to the new medicine or if they might happen naturally or from other influences.
This is a 'Phase 2' study, which means it's an important step in developing new treatments. In this phase, doctors are primarily focused on finding the most effective and safest dose of the new medicine for HS. The study involves hospitals and clinics across different countries and is carefully designed to ensure it's as fair and accurate as possible.
Puntos clave
- Tests a new medicine (SAR445399) for moderate to severe HS.
- Compares the new medicine to a dummy treatment (placebo).
- Aims to find out if the medicine is safe and effective.
- Also looking to find the best dose.
- Participation involves 16 visits over approximately 46 weeks.
- You have the right to withdraw from the study at any time.
¿Quién puede ser elegible?
To join this study, adult participants must have been diagnosed with Hidradenitis Suppurativa (HS) for at least six months. Your HS needs to be affecting at least two different body areas, and at least one of these areas should be classified as moderate or severe. You also need to have at least five active inflamed lumps or painful bumps at the very start of the study.
Another important point is that your doctors must have tried giving you antibiotics for your HS symptoms, and they either didn't work well enough, your symptoms came back after you stopped taking them, or you couldn’t tolerate the antibiotics, or you couldn't take them for other medical reasons. Also, some participants may not have tried any 'biologic' medicines before for HS, while others will have a history of using at least one type of biologic therapy for their HS in the past.
You would not be able to join the study if you have other active skin conditions that might make it hard to check your HS, or if you have certain infections, problems with your immune system, or experienced certain serious health conditions in the past. This includes a history of cancer (unless it was completely treated skin cancer), or if you've had an organ or stem cell transplant.
¿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.
- ¿Eres un adulto de 18 años o más?
- Have you had HS for at least 6 months?
- Does your HS affect at least two body areas, with at least one moderate to severe?
- Do you currently have at least 5 active inflamed lumps or painful bumps from HS?
- Have standard antibiotics for your HS not worked well enough, or could you not take them?
- Do you not have other serious health conditions that might interfere with the study?
¿En qué consiste la participación?
If you decide to take part in this study, your journey will last about 46 weeks, which is a bit under a year. During this time, you will have a total of 16 visits to the study clinic or hospital. For the first 32 weeks, you'll be actively receiving either the study medicine (SAR445399) or the dummy treatment (placebo). This 32-week period is split into two halves: for the first 16 weeks, neither you nor your study doctor will know if you're getting the active medicine or the placebo. For the second 16 weeks, you will continue to receive treatment, but during this time, the study team will still be carefully monitoring your progress. Throughout the study duration, you'll have regular appointments where the doctors will check your general health, assess your HS symptoms, and make sure the treatment is safe for you. This will likely involve physical examinations and perhaps some blood tests.
Riesgos y beneficios potenciales
Locations (58)
- Scottsdale Clinical Trials- Site Number : 8400006Código postal verificadoScottsdale, Estados Unidos· Reclutamiento
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400017Código postal verificadoNorth Hollywood, United States· Reclutamiento
- Encore Medical Research of Boynton Beach- Site Number : 8400005Código postal verificadoBoynton Beach, United States· Reclutamiento
- FXM Clinical Research - Fort Lauderdale- Site Number : 8400013Código postal verificadoFort Lauderdale, United States· Reclutamiento
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007Código postal verificadoFort Myers, United States· Reclutamiento
- Encore Medical Research - Hollywood- Site Number : 8400004Código postal verificadoHollywood, Estados Unidos· Reclutamiento
- Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014Código postal verificadoMiami, United States· Reclutamiento
- Florida International Research Center- Site Number : 8400002Código postal verificadoMiami, United States· Reclutamiento
- Florida Research Center- Site Number : 8400009Código postal verificadoMiami, United States· Reclutamiento
- Advanced Clinical Research Institute- Site Number : 8400021Código postal verificadoTampa, Estados Unidos· Reclutamiento
- Cleaver Medical Group Dermatology- Site Number : 8400008Código postal verificadoCumming, United States· Reclutamiento
- First Georgia Physician Group- Site Number : 8400033Código postal verificadoFayetteville, United States· Reclutamiento
Preguntas comunes
What is Hidradenitis Suppurativa (HS)?
HS is a long-term skin condition causing painful lumps and boils, mainly in areas where skin rubs together like armpits and inner thighs.
What is a 'placebo' in this study?
A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers see if the actual medicine truly works.
¿Cuánto tiempo estaré en el estudio?
The study will last for up to 46 weeks, with 32 weeks of active treatment (either medicine or placebo).
¿Sabré si estoy recibiendo el medicamento real o el placebo?
For the first 16 weeks, neither you nor your study doctor will know. This is called a 'double-blind' study to ensure fair results.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.
Cómo obtener más información
Correo electrónico de Transparencia de Prueba recomendado (Llamada gratuita para EE. UU. y Canadá)
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.