A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years or Older With Juvenile Psoriatic Arthritis

What this Trial Is About

Researchers are evaluating the long-term safety of apremilast in children aged 2 years or older with oral ulcers linked to Behçet's disease, and in children aged 5 years or older with active juvenile psoriatic arthritis who have completed prior related studies. This phase 3, multicenter, open-label extension study aims to monitor safety outcomes over an extended period. Participants receive apremilast orally in doses based on body weight: those weighing between 12 kg and less than 20 kg receive 10 mg twice daily, those between 20 kg and less than 50 kg receive 20 mg twice daily, and those weighing 50 kg or more receive 30 mg twice daily. The study continues treatment and observation over approximately four years, focusing on long-term effects. During the study, researchers will monitor participants for adverse events, changes in vital signs, laboratory parameters, growth measures such as height, weight, and BMI, and assess suicide risk using the Columbia-Suicide Severity Rating Scale. Tanner staging will also be evaluated to assess physical development. Participants are expected to attend scheduled visits and adhere to protocol requirements throughout the study period, which may last up to around four years.

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis