A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
Start Date
11/3/2025
Completion Date
5/17/2028
Summary
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
Detailed Description
This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included. This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.
Eligibility Criteria
Age Range: 1 years to 100 years
Interventions
MAS825
Conditions
Locations
Cincinnati Childrens Hospital
Cincinnati, Ohio 45229
United States
Legacy Emanuel Research Hosp Portland
Portland, Oregon 97232
United States
Novartis Investigative Site
Montreal, Quebec H3T 1C5
Canada
Novartis Investigative Site
Montreal, Quebec H4A 3J1
Canada
Novartis Investigative Site
Bordeaux, 33076
France
Novartis Investigative Site
Bron, 69677
France
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
France
Novartis Investigative Site
Lille, 59037
France
Novartis Investigative Site
Paris, 75015
France
Novartis Investigative Site
Paris, 75970
France
Novartis Investigative Site
Sankt Augustin, North Rhine-Westphalia 53757
Germany
Novartis Investigative Site
Heidelberg, 69120
Germany
Novartis Investigative Site
Münster, 48149
Germany
Novartis Investigative Site
Florence, FI 50139
Italy
Novartis Investigative Site
Genova, GE 16147
Italy
Novartis Investigative Site
Roma, RM 00165
Italy
Novartis Investigative Site
Utrecht, 3584 CX
Netherlands
Novartis Investigative Site
Esplugues, Barcelona 08950
Spain
Novartis Investigative Site
Madrid, 28046
Spain
Novartis Investigative Site
Valencia, 46026
Spain
Novartis Investigative Site
Istanbul, Fatih 34098
Turkey (Türkiye)
Novartis Investigative Site
Ankara, Sihhiye-Altindag 06230
Turkey (Türkiye)