NCT07429266RecruitingPhase 3
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 25 May 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07429266
- EU CT number
- 2025-524669-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 250
- From 25 May 2026 to the primary completion date, 30 Sept 2028
- 115 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (115)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Steiermaerkische Krankenanstalten Ges.m.b.H. Coordinator of this site? Confirm its status | Leoben | Austria | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Oberoesterreichische Gesundheitsholding GmbH Coordinator of this site? Confirm its status | Steyr | Austria | Recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Icon Cancer Centre Kurralta Park Coordinator of this site? Confirm its status | Kurralta Park | Australia | Recruiting |
| Perth Blood Institute Coordinator of this site? Confirm its status | West Perth | Australia | Recruiting |
| Hospital Ophir Loyola Coordinator of this site? Confirm its status | Belém | Brazil | Recruiting |
| Meso Clinic Servicos Medicos Ltda Coordinator of this site? Confirm its status | Blumenau | Brazil | Recruiting |
| Instituto Joinvilense de Hematologia e Oncologia LTDA Coordinator of this site? Confirm its status | Santa Catarina | Brazil | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Not yet recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Not yet recruiting |
| DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU Coordinator of this site? Confirm its status | Deggendorf | Germany | Not yet recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Centrum für Hämatologie und Onkologie Bethanien Coordinator of this site? Confirm its status | Frankfurt | Germany | Not yet recruiting |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Not yet recruiting |
| Universitatsklinikum Halle - Innere Medizin IV Hämatologie und Onkologie Coordinator of this site? Confirm its status | Halle | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Not yet recruiting |
| Universitätsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Not yet recruiting |
| Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Coordinator of this site? Confirm its status | Mutlangen | Germany | Not yet recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Not yet recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire De Rennes Coordinator of this site? Confirm its status | Rennes Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| Royal Devon University Healthcare NHS Foundation Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The New Castle upon Tyne Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Royal Gwent Hospital Coordinator of this site? Confirm its status | Newport | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| GensisCare Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Genesis Care Windsor Coordinator of this site? Confirm its status | Windsor | United Kingdom | Recruiting |
| Cortex Study Center Coordinator of this site? Confirm its status | Budapest II | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Cesena | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Forli' | Italy | Not yet recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Not yet recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Azienda Sanitaria Territoriale di Pesaro e Urbino Coordinator of this site? Confirm its status | Pesaro | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Not yet recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
| Azienda Unita Locale Socio Sanitaria N 8 Berica Coordinator of this site? Confirm its status | Vicenza | Italy | Not yet recruiting |
| Japanese Red Cross Nagasaki Genbaku Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Recruiting |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Unidade Local De Saude Da Regiao De Aveiro E.P.E. Coordinator of this site? Confirm its status | Aveiro | Portugal | Not yet recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Not yet recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
| Unidade Local De Saude Do Alto Minho E.P.E. Coordinator of this site? Confirm its status | Viana do Castelo | Portugal | Not yet recruiting |
| The Center for Cancer & Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Gabrail Cancer Center Research Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Hematology Oncology Associates of Fredericksburg Coordinator of this site? Confirm its status | Fredericksburg | United States | Recruiting |
| The Cancer and Hematology Centers Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| University of Texas M.D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Central Georgia Cancer Care Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
| Regis Clinical Research LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Florida Clinical Trials Group. Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| Florida Clinical Trials Group Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.