Clinical Research Directory
Browse clinical research sites, groups, and studies.
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate clinical efficacy and safety of arumakimig (MAS825) compared to placebo in patients with Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome. In addition, the study will evaluate the long-term efficacy, safety and tolerability of arumakimig in this population.
Official title: VEX-AR: Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase 2 Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome, Followed by an Open-Label Extension Period
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10-30
Completion Date
2031-04-15
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Arumakimig
Arumakimig Injection
Placebo
Placebo Injection
Oral glucocorticoids
Background therapy with glucocorticoids. After the first 2 weeks of the study, participants may begin with glucocorticoid tapering depending on the disease status and the Investigator's judgement.
Locations (3)
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan