A Phase 3 Long-term Extension Study of Apremilast in Pediatric Patients with Behçet’s Disease-Associated Oral Ulcers or Juvenile Psoriatic Arthritis

The primary objective is to evaluate the long-term safety of apremilast in pediatric subjects aged 2 years or older with oral ulcers associated with Behçet’s disease or subjects aged 5 years or older with active juvenile psoriatic arthritis. 4

This study involves 24 participants diagnosed with either Behçet’s disease or juvenile idiopathic arthritis. The study population consists of pediatric and adolescent patients, including both males and females, who are considered a vulnerable population. Participants must be at least 2 years of age with oral ulcers associated with Behçet’s disease or at least 5 years of age with active juvenile idiopathic arthritis. Inclusion requires that subjects are under 18 years of age and have completed specific previous treatment phases. Additionally, subjects must maintain a body mass index no lower than the 5th percentile according to the CDC growth chart at enrollment.

This Phase 3, multicenter, open-label, long-term extension study is designed to evaluate the long-term safety of apremilast in pediatric subjects. The study includes children aged 2 years or older with oral ulcers associated with Behçet’s disease or children aged 5 years or older with active juvenile psoriatic arthritis who have completed previous treatment phases. The primary objectives involve monitoring adverse events, assessing the Columbia-Suicide Severity Rating Scale, Tanner Staging, body mass index, vital signs, and laboratory parameters. Participants must have a body mass index no lower than the 5th percentile on the CDC growth chart at enrollment. Inclusion requires the completion of a 52-week active treatment phase in prior specific studies. The study period is estimated to conclude by December 2032.

The experimental treatment consists of apremilast administered in a 60 mg dose. The medication is provided in either film coated tablet or oral solution pharmaceutical forms. The route of administration is oral.

The assessment of efficacy and safety in this clinical trial involves the monitoring of several parameters. The primary endpoints include the evaluation of adverse events, specifically regarding their type, frequency, severity, and relationship to apremilast. Clinical assessments are conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS) and Tanner Staging. Additional measurements include body weight, height, and body mass index (BMI), as well as vital signs and laboratory parameters.