A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: VEXAS, VEXAS Syndrome
In brief
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. 78 participants will be enrolled, randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. Randomization will be stratified by prescribed GC dose on the day of randomization.
Key facts
- Study ID
- NCT06782373
- Run by
- Swedish Orphan Biovitrum
- People needed
- 78
- Starts
- 2025-05-28
- Expected to finish
- 2028-05-22
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- Cleveland Clinic - Cleveland — Cleveland, Ohio, United States (enrolling)
- The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (enrolling)
- UT MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Utah Healthcare — Salt Lake City, Utah, United States (enrolling)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
- Vancouver Coastal Health Research Institute — Vancouver, British Columbia, Canada (enrolling)
- Queen Elizabeth II Health Sciences Center — Halifax, Nova Scotia, Canada (enrolling)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- Hospital du Sacre-Coeur in Montreal — Montreal, Quebec, Canada (enrolling)
- Lille University Hospital Center — Lille, France (enrolling)
- Saint-Antoine Hospital - APHP — Paris, France (enrolling)
- Tenon Hospital - APHP — Paris, France (enrolling)
- Hospices Civils de Lyon - Lyon Sud — Pierre-Bénite, France (enrolling)
- University Hospital Center of Poitiers — Poitiers, France (enrolling)
- IUCT-Oncopole — Toulouse, France (enrolling)
- University Hospital Tuebingen, Medical Clinic II, Hematology, Oncology, Clinical Immunology and Rheumatology — Tübingen, Baden-Wurttemberg, Germany (enrolling)
- Hospital Rechts der Isar of the Technical University of Munich, Clinic and Polyclinic for Internal Medicine III: Hematology and Internal Oncology — Munich, Bavaria, Germany (enrolling)
- University Hospital Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
- University Hospital Duesseldorf — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
- University Hospital Carl Gustav Carus Dresden, Medical Clinic and Polyclinic I — Dresden, Saxony, Germany (enrolling)
- University Hospital Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (enrolling)
Full record on ClinicalTrials.gov
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