A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Enrollment reopened
    • Site details revised at 39 of 39 sites
  2. Primary endpoint(s) modified Show 7 more changesShow less
    • Enrollment increased: 78 → 156 participants
    • Study completion pushed from May 22, 2028 to May 22, 2030
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 104 words
    • Site details revised at 2 of 39 sites
    • Publications: details revised at 1 of 1 entry
  3. Enrollment closed, study ongoing
    • Site details revised at 39 of 39 sites
    v15
  4. Study sites: 40 to 39v14
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 40 of 40 sites
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Aug 2027 to Dec 30, 2026
    • Study completion date: Aug 2027 to May 22, 2028
    v12
  2. Trial status: Recruiting to Active, Not Recruitingv11 Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (13)
    • Study description expanded, about 54 words
    • Site details revised at 40 of 40 sites
  3. Site details revised at 5 of 40 sitesv10
  4. Re-verified, no change to tracked fieldsv9
  5. Site details revised at 25 of 40 sitesv8
  6. Start date changed from estimate of May 2025 to May 28, 2025
    • Site details revised at 3 of 40 sites
    v7
  7. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 40 of 40 sites
    v6
  8. Re-verified, no change to tracked fieldsv5
  9. Study sites: 36 to 40v4
  10. Study sites: 37 to 36v3
  11. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i.e., Vacuoles in myeloid progenitors, E1 ubiquitin-activating enzyme, X-linked, autoinflammatory manifestations, and somatic) syndrome. In phase 2a, approximately 78 participants will be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. In Phase 2b, approximately 78 participants will be randomized. Phase 2b participants will initially be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. After dose selection, Phase 2b further participants will be randomized to either the selected pacritinib dose or placebo. Randomization will be stratified by prescribed GC dose on the day of randomization.
Trial Details
NCT Number NCT06782373
Lead Sponsor Swedish Orphan Biovitrum
Collaborators: PSI CRO
Conditions
(from sponsor)		 VEXAS, VEXAS Syndrome
Related terms Hematologic Neoplasms, Myelodysplastic Syndromes, VEXAS syndrome
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov