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RECRUITING
NCT07748624
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Arumakimig

Arumakimig Injection

DRUG

Placebo

Placebo Injection

DRUG

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