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
- Alexandria, Ancona, Bergamo, Bologna, Cesena, Florence, Forli', Genoa, Meldola, Milan, Monza, Naples, Novara, Pavia, Pesaro, Rome, Turin, Udine, Verona, and Vicenza, ItalySee the 23 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, ItalyTaking people
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaCesena, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaForli', ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people
- Azienda Unita Locale Socio Sanitaria N 8 BericaVicenza, ItalyTaking people
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.