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

RecruitingPhase 3

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
2. Participants must be phlebotomy-dependent.
3. Hct less than (\<) 45% at study start.
4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.
5. Adequate organ function and electrolytes.

Exclusion Criteria:

1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.
2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.
3. Participants who require phlebotomy at Hct levels \<45%.
4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.

About the study

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.

What is being tested

Sponsor: Ono Pharmaceutical Co., Ltd. · Participants: 250 · Started: May 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07429266

Locations in the U.S.

FloridaRegis Clinical Research LLC., Miami
Florida Clinical Trials Group, Plantation
Florida Clinical Trials Group, Tamarac
GeorgiaCentral Georgia Cancer Care, Macon
MarylandThe Center for Cancer & Blood Disorders, Bethesda
MichiganThe Cancer and Hematology Centers, Grand Rapids
New YorkMontefiore Medical Center, The Bronx
OhioGabrail Cancer Center Research, Canton

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.