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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Polycythemia Vera

In brief

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.

Key facts

Study ID

NCT07429266

Run by

Ono Pharmaceutical Co., Ltd.

People needed

250

Starts

2026-05-25

Expected to finish

2031-01-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Regis Clinical Research LLC. — Miami, Florida, United States (enrolling)
• Florida Clinical Trials Group — Plantation, Florida, United States (enrolling)
• Florida Clinical Trials Group — Tamarac, Florida, United States (enrolling)
• The Center for Cancer & Blood Disorders — Bethesda, Maryland, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Gabrail Cancer Center Research — Canton, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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