Tests sapablursen with standard care in polycythemia vera
Tests sapablursen added to usual care in adults with polycythemia vera.
Plain-language title generated from the registry record
Registry title: INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Key facts
- Where
- Deggendorf, Dresden, Frankfurt, Greifswald, Halle, Hamburg, Heidelberg, Jena, Mannheim, Mutlangen, and Rostock, GermanySee the 11 sites
- Phase
- Phase 3
Where in Germany
- DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKUDeggendorf, GermanyNot yet recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyNot yet recruiting
- Centrum für Hämatologie und Onkologie BethanienFrankfurt, GermanyNot yet recruiting
- Universitätsmedizin GreifswaldGreifswald, GermanyNot yet recruiting
- Universitatsklinikum Halle - Innere Medizin IV Hämatologie und OnkologieHalle, GermanyNot yet recruiting
- University Medical Center Hamburg-EppendorfHamburg, GermanyNot yet recruiting
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyNot yet recruiting
- Universitaetsklinikum Jena KöRJena, GermanyNot yet recruiting
- Universitätsklinikum MannheimMannheim, GermanyNot yet recruiting
- Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen RechtsMutlangen, GermanyNot yet recruiting
- Rostock University Medical CenterRostock, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT07429266EU 2025-524669-25-00
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
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.
Inclusion: Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV; Participants must be phlebotomy-dependent; Hct less than (<) 45% at study start; Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start; Adequate organ function and electrolytes.
Exclusion: Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics; Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization; Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements; Participants who require phlebotomy at Hct levels <45%; Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.