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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
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Sapablursen
Administered subcutaneously (SC)
Placebo
Administered SC
Locations (17)
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
Perth Blood Institute
West Perth, Western Australia, Australia
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
MICS Centrum Medyczne Torun
Torun, Poland
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
The New Castle upon Tyne Hospital
Newcastle upon Tyne, United Kingdom
Genesis Care Windsor
Windsor, United Kingdom