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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MAS825

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators