Estudio Pediátrico de Apremilast en Niños con Úlceras Orales Activas Asociadas con la Enfermedad de Behçet

To be considered for this study, your child must be between 2 and 17 years old. They need to have a confirmed diagnosis of Behçet's disease and have experienced mouth ulcers at least three times in the year before the study starts. Importantly, they must also have at least two active mouth ulcers both when they are first screened and on the day they officially join the study.

Your child should also have tried at least one other non-biologic treatment for their Behçet's disease in the past, such as steroid creams for their mouth or other general medications. This research is not suitable if your child has severe Behçet's disease affecting major organs like their lungs, gut, or brain, or if their eyes are badly affected and require strong immune-suppressing medicines right now. However, if these severe issues happened a while ago (at least a year) and are currently stable, they might still be able to join. Mild eye problems or Behçet's-related joint pain or skin rashes are generally allowed.

If your child takes part, they will receive either apremilast tablets or a placebo, which they will take regularly. Over a 12-week period, they will have several visits to the study clinic where the medical team will check their overall health, monitor their mouth ulcers, and record any changes. These visits will involve physical examinations, potentially blood tests, and discussions about how your child is feeling and how their ulcers are progressing. After the initial 12 weeks, there will be further follow-up appointments to ensure continued safety and gather more information about the long-term effects of the treatment. The total duration of participation in the study will be explained in full detail by the study team.