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INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Sponsor: Ono Pharmaceutical Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-05-25
Completion Date
2031-01
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Sapablursen
Administered subcutaneously (SC)
Placebo
Administered SC
Locations (38)
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
Regis Clinical Research LLC.
Miami, Florida, United States
Florida Clinical Trials Group
Plantation, Florida, United States
Florida Clinical Trials Group
Tamarac, Florida, United States
Central Georgia Cancer Care
Macon, Georgia, United States
The Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Montefiore Medical Center
The Bronx, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Perth Blood Institute
West Perth, Western Australia, Australia
Austin Health
Heidelberg, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, Australia
Medizinische Universität Graz, Klinische Abteilung für Hämatologie
Graz, Austria
Hospital Ophir Loyola
Belém, Pará, Brazil
Meso Clinic Servicos Medicos Ltda
Blumenau, Santa Catarina, Brazil
Instituto Joinvilense de Hematologia e Oncologia LTDA
Santa Catarina, Brazil
Centre Hospitalier Universitaire d'Angers
Angers, France
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Cortex Study Center
Budapest, Hungary
Gyor-Moson-Sopron County Petz Aladar University Teaching Hospital
Győr, Hungary
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Institute of Science Tokyo Hospital
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Aidport Sp. z. o. o.
Skórzewo, Poland
MICS Centrum Medyczne Torun
Torun, Poland
Pratia Onkologia Wroclaw
Wroclaw, Poland
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
The New Castle upon Tyne Hospital
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
GensisCare
Oxford, United Kingdom
Genesis Care Windsor
Windsor, United Kingdom