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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.
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

Full criteria on ClinicalTrials.gov

Sites (115)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Steiermaerkische Krankenanstalten Ges.m.b.H.
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LeobenAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Oberoesterreichische Gesundheitsholding GmbH
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SteyrAustriaRecruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
Icon Cancer Centre Kurralta Park
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Kurralta ParkAustraliaRecruiting
Perth Blood Institute
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West PerthAustraliaRecruiting
Hospital Ophir Loyola
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BelémBrazilRecruiting
Meso Clinic Servicos Medicos Ltda
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BlumenauBrazilRecruiting
Instituto Joinvilense de Hematologia e Oncologia LTDA
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Santa CatarinaBrazilRecruiting
University Hospital Olomouc
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OlomoucCzechiaNot yet recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaNot yet recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaNot yet recruiting
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
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DeggendorfGermanyNot yet recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyNot yet recruiting
Centrum für Hämatologie und Onkologie Bethanien
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FrankfurtGermanyNot yet recruiting
Universitätsmedizin Greifswald
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GreifswaldGermanyNot yet recruiting
Universitatsklinikum Halle - Innere Medizin IV Hämatologie und Onkologie
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HalleGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyNot yet recruiting
Universitätsklinikum Mannheim
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MannheimGermanyNot yet recruiting
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
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MutlangenGermanyNot yet recruiting
Rostock University Medical Center
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RostockGermanyNot yet recruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire De Rennes
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Rennes Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Royal Devon University Healthcare NHS Foundation Trust
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ExeterUnited KingdomRecruiting
Imperial College Healthcare NHS Trust
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LondonUnited KingdomRecruiting
The New Castle upon Tyne Hospital
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Newcastle upon TyneUnited KingdomRecruiting
Royal Gwent Hospital
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NewportUnited KingdomRecruiting
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomRecruiting
GensisCare
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OxfordUnited KingdomRecruiting
Genesis Care Windsor
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WindsorUnited KingdomRecruiting
Cortex Study Center
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Budapest IIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryRecruiting
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
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AlexandriaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyNot yet recruiting
Azienda Unita Sanitaria Locale Della Romagna
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CesenaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
Azienda Unita Sanitaria Locale Della Romagna
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Forli'ItalyNot yet recruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyNot yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyNot yet recruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyNot yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyNot yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyNot yet recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyNot yet recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyNot yet recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyNot yet recruiting
Azienda Sanitaria Territoriale di Pesaro e Urbino
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PesaroItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyNot yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyNot yet recruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyNot yet recruiting
Azienda Unita Locale Socio Sanitaria N 8 Berica
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VicenzaItalyNot yet recruiting
Japanese Red Cross Nagasaki Genbaku Hospital
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NagasakiJapanRecruiting
Osaka Metropolitan University Hospital
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OsakaJapanRecruiting
Tokyo Women's Medical University Hospital
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TokyoJapanRecruiting
Institute of Science Tokyo Hospital
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TokyoJapanRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandRecruiting
Pratia S.A.
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WroclawPolandRecruiting
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
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AveiroPortugalNot yet recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalNot yet recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalNot yet recruiting
Unidade Local De Saude Do Alto Minho E.P.E.
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Viana do CasteloPortugalNot yet recruiting
The Center for Cancer & Blood Disorders
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BethesdaUnited StatesRecruiting
Gabrail Cancer Center Research
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CantonUnited StatesRecruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University
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ColumbusUnited StatesRecruiting
Hematology Oncology Associates of Fredericksburg
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FredericksburgUnited StatesRecruiting
The Cancer and Hematology Centers
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Grand RapidsUnited StatesRecruiting
University of Texas M.D. Anderson Cancer Center
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HoustonUnited StatesRecruiting
Central Georgia Cancer Care
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MaconUnited StatesRecruiting
Regis Clinical Research LLC
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MiamiUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Florida Clinical Trials Group.
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PlantationUnited StatesRecruiting
Florida Clinical Trials Group
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TamaracUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.