J5D-MC-FPAD: A Phase 2a, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Non-Segmental Vitiligo
This research study, called J5D-MC-FPAD, is looking into a new medicine, LY4005130, for adults who have non-segmental vitiligo. This type of vitiligo causes white patches on the skin, often in various places on the body. The main goal is to find out if this new medicine can help improve vitiligo on the face and if it's safe to use. We want to see how many people experience a significant improvement in their facial vitiligo. The study will last for 24 weeks (about 6 months). Some participants will receive the active medicine, while others will receive a placebo (a dummy treatment that looks like the real medicine but has no active ingredients). This helps researchers understand the true effect of the new medicine. It's a 'proof-of-concept' study, meaning it's an early step to see if the idea behind the medicine is promising.
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¿De qué trata este estudio?
Vitiligo is a long-term condition where patches of skin lose their colour. This happens because the cells that produce skin pigment, called melanocytes, are destroyed. Non-segmental vitiligo is the most common type, affecting different parts of the body, often symmetrically. While not physically harmful, it can significantly impact how people feel about their appearance and their quality of life.
This study, called J5D-MC-FPAD, is testing a new medicine called LY4005130. It's designed to explore if this medicine can help restore colour to the white patches, particularly on the face. Face vitiligo can be particularly distressing, so finding effective treatments is a priority. The study is a 'Phase 2a' trial, which means it's an early stage of testing where researchers are looking closely at how well the medicine works and if it has any side effects, rather than just confirming basic safety.
Over 24 weeks, participants will either receive the new medicine or a placebo. This setup helps researchers fairly compare the effects of the active medicine against no active treatment. By carefully measuring changes in facial vitiligo and monitoring participants' health, the study aims to gather important information that could lead to new treatment options for people living with vitiligo in the future.
Puntos clave
- This study is for adults with non-segmental vitiligo.
- It's testing a new medicine (LY4005130) to see if it helps facial vitiligo.
- The study lasts about 6 months and involves regular clinic visits.
- You might receive the new medicine or a dummy treatment (placebo).
- All study costs for medicines and tests are covered.
- Taking part helps advance research for vitiligo treatments.
¿Quién puede ser elegible?
To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
The most important requirement is that you must have non-segmental vitiligo. This means your white patches of skin are spread across different areas of your body, rather than being limited to just one side or segment.
There will be other medical checks and tests to make sure that taking part in the study is safe for you and that the results of the study are clear and reliable. These checks will be explained in detail by the study team.
¿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?
- Do you have non-segmental vitiligo?
- Are you able to attend regular clinic visits for 6 months?
- Are you willing to potentially receive a placebo?
- Are you both male or female?
¿En qué consiste la participación?
If you decide to join this study, your participation will last for approximately 24 weeks (about 6 months). You'll be randomly assigned to either receive the new medicine, LY4005130, or a placebo (a dummy treatment). You won't know which one you're receiving, and neither will the study doctors – this is called 'double-blind' and helps ensure fair results.
Throughout the study, you'll have several scheduled visits to the clinic. These visits will involve various assessments, such as physical examinations, blood tests, and detailed photographs or measurements of your vitiligo patches, especially on your face. You'll also be asked to report any changes in your health or any side effects you experience. All study medication and assessments will be provided at no cost to you.
Riesgos y beneficios potenciales
Ubicaciones (2)
- —No verificadoPolonia
- —No verificadoBélgica
Preguntas comunes
What type of vitiligo is this study for?
This study is specifically for people who have non-segmental vitiligo.
¿Cuánto tiempo durará el estudio?
If you join, your participation in the study will last for about 24 weeks, which is about 6 months.
Will I know if I'm getting the real medicine or a dummy treatment?
No, neither you nor the doctors will know if you're getting the active medicine or a placebo. This is to ensure fair and unbiased results.
Are there any costs involved for me?
No, all study-related medications and assessments will be provided to you free of charge.
¿Puedo abandonar el estudio en cualquier momento?
Yes, you are free to withdraw from the study at any point, and it will not affect your usual medical care.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.