A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
This study is exploring a new medicine called ritlecitinib for children aged 6 to 11 who have severe alopecia areata, a condition where people lose a lot of their hair. The main goal is to find out if this medicine is safe and effective in helping hair grow back. Some children will receive a higher dose of ritlecitinib, some a lower dose, and others a placebo – which looks like the medicine but contains no active drug. This helps researchers compare the effects. Participants will take the medicine daily as a capsule for 6 months and will have regular clinic visits and phone calls to check on their progress and well-being. It’s important to see if ritlecitinib can improve hair regrowth and daily life for children with this condition.
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¿De qué trata este estudio?
This research study is looking at a new medicine called ritlecitinib, which could potentially help children aged 6 to 11 who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss. In severe cases, people can lose a lot of hair from their scalp, and sometimes from other parts of the body. The purpose of this study is to carefully check if ritlecitinib is safe for children and if it can help their hair grow back.
To understand how well ritlecitinib works, participants will be put into three groups. One group will receive a higher dose of ritlecitinib, another group will get a lower dose, and the third group will receive a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active drug. This comparison helps the researchers to clearly see if any improvements are due to the medicine itself or other factors. All participants will take the study medicine as a capsule by mouth once a day.
By comparing the experiences of children taking ritlecitinib with those taking the placebo, the study hopes to learn more about the potential benefits and any side effects of the medicine. This information is crucial for deciding if ritlecitinib could eventually become a treatment option for children with severe alopecia areata. The study also aims to understand how the medicine affects a child's overall well-being and daily life.
Puntos clave
- Study for children aged 6-11 with severe alopecia areata.
- Investigates a new medicine called ritlecitinib.
- Compares ritlecitinib to a placebo (dummy medicine).
- Participation involves taking a daily capsule for 6 months.
- Includes 8 clinic visits and 8 phone check-ups.
- Aims to assess safety and hair regrowth.
¿Quién puede ser elegible?
This study is looking for children aged 6 to 11 years old. They need to have severe alopecia areata, meaning they've lost at least half of their scalp hair, and this hair loss hasn't improved in the last year. For children living in the UK or EU, they'll also need to have tried other alopecia areata treatments that didn't work well.
All children joining the study must have either had two chickenpox vaccinations or show signs in a blood test that they've had chickenpox before. This is because certain medications can interact with the chickenpox virus.
There are also some reasons why a child might not be able to join the study. For example, if they have certain other types of hair loss, serious medical conditions like some cancers, a history of significant depression, or untreated infections like tuberculosis or hepatitis. Also, if they've had a 'live' vaccine recently, they might need to wait before joining.
¿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.
- Is your child between 6 and 11 years old?
- Has your child lost at least half of their scalp hair due to alopecia areata and it hasn't regrown in the last year?
- For UK/EU children: Have other alopecia treatments not worked for your child?
- Has your child had two chickenpox jabs, or have they had chickenpox before (confirmed by a blood test)?
- Does your child have any other serious medical conditions like certain severe infections or past cancers?
¿En qué consiste la participación?
If your child takes part in this study, they will receive a study medicine (ritlecitinib) or a placebo, which is a dummy medicine, in the form of a capsule to take by mouth once a day at home. This will continue for 6 months. During this time, you and your child will attend the study clinic for 8 appointments. These visits are important for the study team to check your child's health, see how the medicine is working, and look for any side effects. The study team will also call you about 8 times over the phone to check in and see how things are going. After the 6 months, if your child meets certain conditions, they might have the option to join a longer-term part of the study.
Riesgos y beneficios potenciales
Locations (83)
- UCI Dermatology Clinical ResearchCódigo postal verificadoIrvine, United States
- Southern California Clinical ResearchCódigo postal verificadoSanta Ana, United States
- Hospital de Niños de ColoradoCódigo postal verificadoAurora, Estados Unidos
- Children's National Medical CenterCódigo postal verificadoWashington D.C., Estados Unidos
- Pediatric Skin ResearchCódigo postal verificadoMiami, United States
- Endeavor Health Audiology -CHICAGOCódigo postal verificadoChicago, Estados Unidos
- Endeavor Health Behavioral Health - EvanstonCódigo postal verificadoEvanston, United States
- Endeavor Health Clinical OperationsCódigo postal verificadoEvanston, United States
- Endeavor Health Audiology -LAKE BLUFFCódigo postal verificadoLake Bluff, United States
- Endeavor Health Audiology-NORTHBROOKCódigo postal verificadoNorthbrook, United States
- Endeavor Health Audiology-SKOKIECódigo postal verificadoSkokie, United States
- Endeavor Health Clinical OperationsCódigo postal verificadoSkokie, United States
Preguntas comunes
¿Qué es la alopecia areata?
Alopecia areata is a condition where your immune system, which normally fights off infections, mistakenly attacks your hair follicles, leading to hair loss on the scalp and sometimes other parts of the body.
¿Qué es un 'placebo'?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare if the real medicine is having an effect.
¿Cuánto dura el estudio?
The main part of the study will last for 6 months for your child. During this time, there will be 8 clinic visits and about 8 phone calls with the study team.
Will my child know if they are getting the real medicine or the placebo?
No, neither you, your child, nor the study team will know which treatment your child is receiving during the main 6-month period. This is to ensure the results are fair and unbiased.
What if my child feels unwell during the study?
Any concerns about your child's health must be reported immediately to the study team, who will provide guidance and care.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.