Stills disease

Clinical Trial Title An open-label phase II trial to evaluate the clinical efficacy, safety and tolerability of MAS825 in pediatric and adult participants with Still’s disease
Trial Status Open to Enrollment
Start Date 07/22/2025
Location Randall Children’s Rheumatology
Trial Type Pediatric Rheumatology
Specific Condition Still’s disease
Description

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.

This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.

This site will only be enrolling pediatric patients.
Eligibility Criteria
  • Age ≥ 1 with a diagnosis of Still's Disease
  • Active diseases defined as:
  • CRP or ferritin levels greater than ULN, and any of:
    • 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
    • Serositis or
    • Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator
  • Intolerance or inadequate response to available biologic therapy
IRB Number 10912
Notes A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
Principal Investigator Daniel Kingsbury, MD
Contact Name Brenna Bogle
Contact Phone 503-413-3508
Contact Fax 503-413-3543
Contact E-Mail bbogle@lhs.org