Phase II Study of MAS825 to Assess Safety and Effectiveness in Children and Adults with Stills Disease

What this Trial Is About

Researchers are conducting a phase II trial to evaluate the clinical benefit, safety, and tolerability of MAS825 arumakimig in both children and adults diagnosed with Stills disease who have not responded adequately to IL-1 andor IL-6 or other available treatments. The study also includes participants with associated lung disease or macrophage activation syndrome. This trial is open-label and single-arm, aiming to assess MAS825 in this patient group. Participants will receive the experimental drug MAS825 during two treatment periods following an initial screening phase. The total study duration for each participant is approximately 16 months. The trial is designed with three periods Screening, Treatment Period 1, and Treatment Period 2. MAS825 administration is the focus throughout the treatment periods, with no placebo or comparator groups. During the study, participants will undergo assessments including clinical response evaluations based on specific criteria by Day 85, biomarker level measurements, physician assessments, and quality of life evaluations. Researchers will monitor changes in glucocorticoid dosage and disease activity over time. Safety and tolerability are closely followed, and inactive disease status while on low-dose corticosteroids will be assessed by 15 months. The study is sponsored by Novartis Pharmaceuticals and includes both pediatric and adult participants aged 1 to 100 years.

A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease