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NCT07429266PHASE3Recruiting

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

Ono Pharmaceutical Co., Ltd.

Start Date

5/25/2026

Completion Date

1/1/2031

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). Participants may receive treatment for up to 156 weeks.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sapablursen

DRUG

Placebo

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Conditions

Polycythemia Vera

Locations

Regis Clinical Research LLC.

Miami, Florida 33126

United States

Florida Clinical Trials Group

Plantation, Florida 33322

United States

Florida Clinical Trials Group

Tamarac, Florida 33321

United States

The Center for Cancer & Blood Disorders

Bethesda, Maryland 20817

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Gabrail Cancer Center Research

Canton, Ohio 44718

United States