The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease
Age ≥ 1 with a diagnosis of Still's Disease
Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or
Rash attributed to Still's Disease activity or
Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or
Patients out of weight range
Ongoing or previous treatment with immunomodulatory drugs
A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study
Glucocorticoid dose exceeding a set limit
Single group
MAS825
DrugExperimental drug
Number of participants with clinical response based on one set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Number of participants with clinical response based on another set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Response based on a biomarker level
To evaluate the efficacy of MAS825 in reducing clinical disease activity
Change in physician assessment based on laboratory features of MAS825
To assess the effect of MAS825 on macrophage activation syndrome
Change from baseline in Glucocorticoid (GC) dose
To evaluate the efficacy of MAS825 as a glucocorticoid-sparing agent
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