Study of Subcutaneous Risankizumab Compared to Adalimumab for Treating Juvenile Psoriatic Arthritis in Children Aged 5 to 17

What this Trial Is About

Juvenile psoriatic arthritis jPsA is a form of arthritis where the immune system attacks healthy joints, causing pain, stiffness, and swelling. This condition starts before age 16 and can worsen or improve over time. Researchers are studying how safe risankizumab is for treating jPsA and how it affects disease symptoms compared with adalimumab, which is already approved for this condition. This is a Phase 3 interventional trial enrolling about 40 children worldwide to evaluate these treatments. Participants are randomly assigned to receive either risankizumab or adalimumab given as subcutaneous injections based on their body weight. The study has two periods Period 1 lasts 24 weeks, where participants receive the assigned treatment. Those who respond continue with the same treatment for another 100 weeks in Period 2. Participants who worsen in Period 2 will stop the study treatment. After finishing treatment, there is a safety follow-up lasting 140 days for risankizumab and 70 days for adalimumab. During the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers will measure improvements using criteria such as the Juvenile Idiopathic Arthritis American College of Rheumatology response and track adverse events up to week 144. The total participation time includes treatment periods plus safety follow-up, lasting several years.

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab