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Polycythemia VeraPhase 3INTREPIDNCT07429266

INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)

A Phase 3 study testing Sapablursen in people with Polycythemia Vera, run by Ono Pharmaceutical Co., Ltd. at 32 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polycythemia Vera
What is being tested?
Sapablursen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
32 sitesin 7 countries
Study dates
25 May 2026to Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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.
  • Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.

Trial locations and contacts

32 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Clinical Team contact

888-724-3274

clinicaltrials@deciphera.com

32 sites in 7 countries

United States12 sites, 12 recruiting

  • The Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

    Taylor Stutzman, 301-571-0019 ext. 410, Taylor.Stutzman@aoncology.com

    Victor M Priego, MD

    Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com

    Nashat Y Gabrail, MD

    Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University

    Columbus, Ohio, 43210

    Tyler Srail, Tyler.srail@osumc.edu

    Jennifer Vaughn, MD

    Recruiting

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408

    Wendy Azucena, Wendy.Azucena@aoncology.com

    Lakshminarayanan Nandagopal, MD

    Recruiting

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49503

    616-954-9800, ClinicalTrials@chcwm.com

    Daniel Foley, MD

    Recruiting

  • Central Georgia Cancer Care

    Macon, Georgia, 31210

    Mackenzie Sanders, 4787437068, mackenzie.sanders@aoncology.com

    Bradley Sumrall, MD

    Recruiting

  • Regis Clinical Research LLC.

    Miami, Florida, 33126

    Roberto Reyes, 305-546-3952, rreyes@regisclinical.com

    Yilena Rodriguez Marrero, MD

    Recruiting

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 93868

    Kelsey Edwards, 714-509-2705, kmcabee@hs.uci.edu

    Angela Fleischman, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Jill Samaha, 215-214-3125, Jill.Samaha@fccc.edu

    Iberia Sosa, MD

    Recruiting

  • Florida Clinical Trials Group

    Plantation, Florida, 33322

    (772) 297-3057, harshamin@floridactg.com

    Harshad Amin, MD

    Recruiting

  • Florida Clinical Trials Group

    Tamarac, Florida, 33321

    Maria Abreu, (772) 297-3057, abreum@floridactg.com

    Chintan Gandhi, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Joty Rashid, 718-219-8181, jorashid@montefiore.org

    Swati Goel, MD

    Recruiting

Other trials in United States

United Kingdom7 sites, 7 recruiting

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, EX2 5DW

    April Bradbeer, 01392 402871, a.bradbeer1@nhs.net

    Jason Coppell, MD

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

    Neil Simpson, 2037034340, neil.simpson5@nhs.net

    Andrew Innes

    Recruiting

  • The New Castle upon Tyne Hospital

    Newcastle upon Tyne, NE7 7DN

    Laura Gebbie, 1912139330, l.gebbie@nhs.net

    Andrew McGregor, MD

    Recruiting

  • Royal Gwent Hospital

    Newport, NP20 2UB

    Jane McCarthey, 01633 238480, Jane.McCarthy2@wales.nhs.uk

    Ali Mahdi

    Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

    Jess Ariola, 01159691169 ext. 73474, jesusa.ariola@nhs.net

    Frances Wadelin

    Recruiting

  • GensisCare

    Oxford, OX4 6LB

    Suzanne Titcombe, 7407796352, Suzanne.titcombe@genesiscare.co.uk

    Adam Mead

    Recruiting

  • Genesis Care Windsor

    Windsor, SL4 3HD

    Dylan Sihra, 7879262807, dylan.sihra@genesiscare.co.uk

    Pratap Neelkantan, MD

    Recruiting

Other trials in United Kingdom

Japan4 sites, 4 recruiting

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Recruiting

  • Institute of Science Tokyo Hospital

    Tokyo, 113-8510

    Recruiting

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

    Recruiting

Other trials in Japan

Poland3 sites, 3 recruiting

  • Aidport Sp. z. o. o.

    Skórzewo, 60-185

    Michal Kwiatek, Michal.kwiatek@aidport.pl

    Maciej Kazmierczak, MD

    Recruiting

  • MICS Centrum Medyczne Torun

    Torun, 87-100

    Monika Gajewska, 48 665222337, monika.gajewska@mics.medicover.com

    Dominik Chraniuk, MD

    Recruiting

  • Pratia Onkologia Wroclaw

    Wroclaw, 50-019

    Natalia Sauer, natalia.sauer@pratia.com

    Elzbieta Kalicinska, MD

    Recruiting

Other trials in Poland

Australia2 sites, 2 recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037

    Cathy Murphy, +61(8)84740240, cathy.murphy@icon.team

    Stanley Ka Chun Cheung

    Recruiting

  • Perth Blood Institute

    West Perth, Western Australia, 6005

    Antonia Busby, 61 8 9200 5309, antonia@pbi.org.au

    Ross Baker, MD

    Recruiting

Other trials in Australia

Brazil2 sites, 2 recruiting

  • Meso Clinic Servicos Medicos Ltda

    Blumenau, Santa Catarina, 89010-330

    Amanda Souza, 554-799-770-0049, cp@mesoclinic.com.br

    Luiza Beatriz Goncalves Beber

    Recruiting

  • Instituto Joinvilense de Hematologia e Oncologia LTDA

    Santa Catarina, 89201-260

    Larissa Borges, 554734331855, larissa@cho-joi.com.br

    Ivan Boettcher

    Recruiting

Other trials in Brazil

Hungary2 sites, 2 recruiting

  • Cortex Study Center

    Budapest, 1026

    Zsofia Balogh, 36205141256, zsofia.balogh@cortexps.hu

    Árpád Batai, MD

    Recruiting

  • Gyor-Moson-Sopron County Petz Aladar University Teaching Hospital

    Győr, 9024

    Bernadett Lenart, 36-96-507-900/2731, lenartbernadett.study@gmail.com

    Zsolt Lazar, MD

    Recruiting

Other trials in Hungary

About this study

Official title: 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.

Being tested
Sapablursen, Placebo
Medical subject headings
Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SapablursenDrug

    Also called ONO-0530, ISIS 702843

    Administered subcutaneously (SC)

  • PlaceboDrug

    Administered SC

Study groups in NCT07429266
Study groupRoleWhat they receive
SapablursenExperimentalSapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)
Receives: Drug: Sapablursen
PlaceboExperimentalPlacebo (32 Weeks) - Sapablursen (124 Weeks Open-label)
Receives: Drug: Sapablursen; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Absence of Phlebotomy Eligibility

    Response is defined as absence of phlebotomy eligibility.

    Measured: Week 20 through Week 32

Secondary outcomes (7)

  1. Number of Phlebotomies

    Measured: Week 0 through Week 32

  2. Percentage of Participants with Hct Control

    Defined as all local laboratory Hct <45% without phlebotomy.

    Measured: Week 0 to Week 32

  3. Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score

    Measured: Baseline, Week 32

  4. Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS)

    Measured: Baseline, Week 32

  5. Percentage of Participants with Absence of Phlebotomy Eligibility

    Response is defined as absence of phlebotomy eligibility.

    Measured: Week 20 through Week 52

  6. Number of Phlebotomies

    Measured: Week 0 through Week 52

  7. Percentage of Participants with Hct Control

    Defined as all local laboratory Hct <45% without phlebotomy.

    Measured: Week 0 through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start25 May 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07429266
Sponsor's protocol ID
ONO-0530-03-001
Other IDs
2025-524669-25-00, jRCT2071260061, 2025
Acronym
INTREPID
Status last verified
Oct 2026
First submitted
18 Feb 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sapablursen in people with Polycythemia Vera, run by Ono Pharmaceutical Co., Ltd. at 32 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, United Kingdom, Japan, Poland, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Absence of Phlebotomy Eligibility (time frame: Week 20 through Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07429266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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INTREPID Clinical Trial NCT07429266 | AzTrials