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
- Badalona, Barakaldo, Barcelona, L'Hospitalet de Llobregat, Madrid, Málaga, Murcia, Pamplona, Salamanca, Santiago de Compostela, Terrassa, and Valencia, SpainSee the 17 sites
- Phase
- Phase 3
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital Universitario de CrucesBarakaldo, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- Hospital General Universitario Morales MeseguerMurcia, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Fundacio Assistencial De Mutua De Terrassa FpcTerrassa, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking 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.