Phase 2Status unknown
A study evaluating the safety and effectiveness of SIR9900 compared with placebo in adults with VEXAS syndrome
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of SIR9900 in Patients with VEXAS Syndrome (SIVEX)
- Sponsor
- Sironax USA, Inc.
- Enrolment
- 110 planned
- Conditions
- VEXAS syndrome; Inflammatory and Immune System - Autoimmune diseases; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Blood - Other blood disorders
- Interventions
- Participants will be randomised to receive SIR9900 20 mg, SIR9900 30 mg, or matching placebo orally once daily, together with permitted background treatment
- Ages
- adults, older adults
- Registry
- ACTRN12626001126303
Full record on ANZCTRSource: WHO ICTRP, processed 14 September 2026
Primary outcomes
- Proportion of participants achieving Overall Clinical Response (clinical response or better)[Overall Clinical Response is assessed as a yes/no outcome based on a sustained absence of VEXAS-related flare, glucocorticoid use and, where applicable, C-reactive protein (CRP). VEXAS-related inflammatory m
History
Started
Last registry update
Registered