OncoMatch/Clinical Trials/NCT07098936
Momelotinib in VEXAS Syndrome
Is NCT07098936 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Momelotinib treatment for vexas syndome.
Treatment: Momelotinib treatment — Multicenter, phase II trial with safety run-in to evaluate the efficacy and safety of momelotinib in patients with VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome with or without associated myelodysplastic syndrome (MDS). The study will consist of two consecutive steps, a dose-finding safety run-in and a single-arm prospective phase II. During safety run-in phase, three fixed dose levels will be tested according to a 3+3 design, using cohorts of size 3 in order to establish the maximum tolerated dose. After this safety run-in phase, patients included in phase II will be treated with momelotinib at the maximum tolerated dose preliminary fixed. Patients included in the phase II will receive momelotinib continuously until disease progression or loss of response, at physician's discretion. All patients included in the study will receive glucocorticoids (prednisone/prednisolone equivalent) at baseline (at least \> 10mg/day). Response assessment regarding VEXAS related symptoms will be evaluated after 4, 12, 24 and 48 weeks. Response assessment regarding MDS features will be evaluated at 12 and 24 weeks.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: UBA1 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunosuppressive therapy (steroids)
Patients with uncontrolled symptoms related to VEXAS with prior treatment line(s) (including steroids)
Cannot have received: Janus Kinase (JAK) inhibitor
Patients who are or have been already treated with Janus Kinase (JAK) inhibitors for VEXAS syndrome or another indication
Lab requirements
Kidney function
creatinine clearance with MDRD formula > 30 ml/min
Liver function
serum transaminases ≤ 3 x ULN, Bilirubin ≤ 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin fractionated and direct bilirubin < 35%)
Adequate liver function (serum transaminases ≤ 3 x ULN (Upper Limits of Normal), Bilirubin ≤ 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin fractionated and direct bilirubin < 35%)); Adequate renal function (creatinine clearance with MDRD (Modification of Diet in Renal Disease) formula > 30 ml/min)
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