Not Yet RecruitingPhase 2/3

A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome

192 participantsStarted 2026-08-05

Plain-language summary

This study will assess the efficacy and safety of momelotinib in participants with a diagnosis of VEXAS.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Documented evidence of a canonical, pathogenic Ubiquitin-like modifier activating enzyme 1 (UBA1) mutation
✓. Inflammatory manifestations: current or documented past involvement within 6 months of at least one organ system
✓. Is a Participant of non-childbearing potential (PONCBP) OR
✓. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective

✕. VEXAS-directed therapies (washout period) up to 5 half-lives or up 14 days if half-life is \<3 days
✕. Other non-GC anti-inflammatory therapies: for non-biologics): 14 days or five half-lives, whichever is longer; for biologics): 28 days or two half-lives whichever is longer.
✕. Hematologic support therapy (e.g., ESAs, danazol, luspatercept, G-CSF): 4 weeks
✕. Cell-depleting therapies such as anti-CD20 (rituximab): 12 months
✕. Investigational agent from a class not otherwise specified: 5 half-lives or 60 days, whichever is longer
✕. Unstable angina pectoris
✕. Symptomatic congestive heart failure
✕. Uncontrolled cardiac arrhythmia

ORR (Objective response rate) at Week 26

Timeframe: At Week 26

NCT IDNCT07569081

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-06

US GSK Clinical Trials Call Center